Biopad biospray

8/20/2019 Biopad biospray

1/24

EURORESEARCH s.r.l. IST. ED. 1 Rev 1-MR1

Abstracts from the book:1

CCOOLLLLAAGGEENNOO EE CCIICCAATTR R IIZZZZAAZZIIOONNEE

realtà e prospettive terapeutiche

F.Beghè, M.Mian, B.Palmieri

“Collagen and wound-healing – present and future therapies“Collagen and wound healing – International Congress

Istanbul – March 1990


2/24


2

FOREWORD

In the listed clinical experiences and trials, the Euroresearch’s collagen sponge

is mentioned – other than as BIOPAD® – using different brand names andtrademarks merely for marketing purposes, amongst which Condress®,

Gelfix®, Proteita®, and sometimes with laboratory codes BG PRG, EU 10102.

All these brand names (property of Euroresearch), identify the same collagen

sponge undergoing the same manufacturing process, in the same facility and

with the same identical composition and dosage.

EURORESEARCH s.r.l.Via Larga 2 – 20122 Milan Italy

Ph + 3902 8055660 – Fax + 39 02 72011722www. euroresearch.it

[email protected]


3/24


3

IINNDDEEXX

TTIITTLLEE AANNDD AAUUTTHHOOR R ((SS)) PPaaggee

R R OOLLEE OOFF HHEETTEER R OOLLOOGGOOUUSS CCOOLLLLAAGGEENN ((CCOONNDDR R EESSSS)) IINN TTHHEE TTIISSSSUUEE R R EEPPAAIIR R PPR R OOCCEESSSS OOFF WWOOUUNNDDSS IINN R R AATT M.Mian, R.Aloisi, S.Rosini, D.Benetti, R.Fantozzi

5

COLLAGEN IN COMPLEX LOSSES OF SUBSTANCES.Cussotti, M.Carli, M.Fasciolo, E.Cardesi, E.Teta

5

CLINICAL EXPERIENCE ON THE USE OF LYOPHILIZED COLLAGEN INGYNAECOLOGICAL SURGERY

S.Mancuso

6

THE REPAIR OF TRAUMATIC LESIONS OF THE SKIN MEDICATED WITH COLLAGEN R.Rambaldi, A.Lazzerini

7

COLLAGEN IN ORTHOPEDY AND TRAUMATOLOGY G.Soncini, E.Rinaldi

8

CLINICAL AND SURGICAL TESTS WITH COLLAGEN IN ORTHOPEDY E.Tozzi, A.Zampieri, M.Benifei

9

TOPICAL COLLAGEN: RANK AND MECHANISMS M.Mian. E.Mian

10

CLASSIFICATION OF VASCULAR ULCERS. TREATMENT OF VASCULAR ULCERSWITH HETEROLOGOUS COLLAGEN

C.Corsi, S.Giordano

11

OUR EXPERIENCE IN THE TREATMENT OF TROPHIC LESIONS OF LOWER LIMBSUSING HETEROLOGOUS COLLAGEN B. Borreani, L. Brizio, A. Mannari, F. Toniutti

12

CONSERVATIVE TREATMENT OF LEG ULCERS OF DIFFERENT ETIOLOGY. CLINICAL COMPARISON BETWEEN HETEROLOGOUS LYOPHILIZED COLLAGEN ANDHYDROCOLLOID L.Cangiotti, A.Vinco,C.Codignola, A.Coniglio, P.Mujesan, E.Teta,G.A.Tiberio

13

USE OF HETEROLOGOUS COLLAGEN (CONDRESS) IN THE TREATMENT OFMALLEOLAR ULCERS IN THALASSEMIC SUBJECTS N.G.Cavallesco, G.F.Azzena, L. Lupi

14

THE USE OF COLLAGEN IN ANGIOSURGERY G. de Donato, M. Placino, P. De Nicola 15


4/24


4

HETEROLOGOUS COLLAGEN IN THE TREATMENT OF SKIN TROPHIC LESIONS: OUREXPERIENCE

M.Giberto, R.Masini, G.Canova, P.Pramaggiore, M.A.Damerio, G.Becchi

16

PRELIMINARY CLINICAL DATA ON THE USE OF HETEROLOGOUS COLLAGEN INCONTINUALLY SOLUTION SKIN LESIONS

G.Ricotti, M.G.Tucci, A.Pugnaloni, M.M.Tappa, P.Schreiber, G.Biagini

17

TOPICAL THERAPY OF VENOUS ULCERS WITH HETEROLOGOUS COLLAGEN R.Del Guercio, A.Niglio, R.Miranda, M.Del Guercio, G.Siciliano

18

OUR EXPERIENCE ON MORE THAN 2000 CASES OF ULCERS TREATED WITHHETEROLOGOUS LYOPHILIZED COLLAGEN B.Palmieri

19

THE TREATMENT WITH LYOPHILIZED COLLAGEN OF SKIN WOUNDS WITH LOSSOF SUBSTANCE IN ON FIRST AID UNITS

G.Caselli , M.La Cava

20

TREATMENT WITH HETEROLOGOUS LYOPHILIZED COLLAGEN (CONDRESS) OFTHE LESIONS OF BEDRIDDEN PATIENTS

G.Molinari

21

LYOPHILIZED HETEROLOGOUS COLLAGEN AND ITS APPLICATION INDERMOSURGERY: RATIONAL AND RESULTSL.Verani, F.Beghé, A.Zampieri

22

ONE CASE OF NECROSIS OF FOREFOOT G.Etti di Rodeano

23

TOPICAL TREATMENT OF DIABETIC TROPHIC ULCERS USING HETEROLOGOUSCOLLAGEN (CONDRESS) L.Granata, M.Caviglia, A.Battistini, G.L.Viviani, L.Adezati

23

THE USE OF MICROAUTOSKINGRAFTS IN THE TREATMENT OF WIDE PRESSUREULCERS: OUR EXPERIENCE P.Ziccardi, G.Esposito, G.Di Caprio, M.Scioli and N.Scuderi

24


5/24


55

R R OOLLEE OOFF HHEETTEER R OOLLOOGGOOUUSS CCOOLLLLAAGGEENN ((CCOONNDDR R EESSSS11)) IINN TTHHEE TTIISSSSUUEE R R EEPPAAIIR R PPR R OOCCEESSSS OOFF WWOOUUNNDDSS IINN R R AATT

M. Mian, R. Aloisi, S. Rosini, D. Benetti, R. Fantozzi*Research Division Istituto Gentili, Pisa* Pharmacology Institute - Ferrara University, Ferrara Italy

Abstract

The authors describe an experimental wound animal model to test the efficacy of

collagen sponge (Condress) in rats. Criteria evaluated were: 1) volume of exudate inwounds, 2) number of granulocytes, 3) number of macrophages, 4) wound repair.Collagen has shown a significant chemotactic effect in macrophages. The quantity ofexudate was higher in wounds treated with collagen sponge compared to control.Collagen also showed a significant healing process compared to control.

COLLAGEN IN COMPLEX LOSSES OF SUBSTANCE

S.Cussotti, M.Carli, M.Fasciolo, E.Cardesi*, E.Teta**Orthopaedics and Traumatologic Division Hospital Beato Umberto USL 36 - Avigliana (Torino)

* Dept. of Morbid Anatomy - P.O. Martini - US L 3 - Torino** Clinical Research dept. Istituto Gentili - Pisa

Abstract

The authors were treating different types of chronic and acute wounds with collagensponges: 2 pressure ulcers, 3 post – traumatic ulcers, 1 surgical wound dehiscence, 4

complex ulcers. Overall the collagen was able to improve the granulation tissueformation in all the wounds treated and to accelerate the healing process, particularlyreducing complications such as exposed tendons.

1 CONDRESS is one of Euroresearch’s proprietary trade marks used for marketing collagen pads. OtherEuroresearch’s trade marks are BIOPAD, GELFIX, PROTEITA, all of them used to identify the sameidentical collagen pad


6/24


6

CLINICAL EXPERIENCE ON THE USE OF LYOPHILIZED COLLAGEN INGYNAECOLOGICAL SURGERY

S.MancusoObstetrics and gynaecology Clinical Institute - Catholic University of Sacro Cuore - Rome

ABSTRACT

In this study the author reports the results of his clinical experience by using collagensponge in some indications of gynaecological surgery.A total of 204 patients were studied; they required conservative or destructive surgeryfor several clinical indications. Lyophilized collagen proved very handy, useful, safe, innocuous and efficacious in itstopical use in certain gynaecological indications.In all the patients no variations of hemato-chemical tests took place, nor disturbancesimmediately or after the post-operative phase.The collagen soft sponges were applied and left in situ in the cavities created on themyometrium context after enucleation of intramural nodes or uterine myoma.Cicatrization was always satisfactory as shown by the clinical trend and theechotomographic controls afterwards.Whenever collagen was used as haemostat in the abdominal and vaginalhysterectomies no side effects were observed and the clinical examination atdismission and during follow-up never revealed infiltrations into the iliac fossaeindicating exuberant or retractive scars.

Of particular interest was the disappearance of urinary incontinence in almost all casesof cysturethropexy. It is likely that collagen contributed to the consolidation of thesuburethral floor after Kelly’s plastic surgery, also when the muscular-membraneoustissue was not particularly rich, making the operation more effective and the resultsmore satisfactory.The few cases of dysuria reported, can be linked to the implant of the catheter in thedays after the operation, in particularly reactive patients.We conclude therefore that the results obtained should suggest the use of lyophilizedcollagen for above indications and possibly for wider applications and in other cases ofgynaecological surgery.


7/24


7

THE REPAIR OF TRAUMATIC LESIONS OF THE SKIN MEDICATED WITHCOLLAGEN

R. Rambaldi, A. Lazzerini*Division of Orthopaedics and Traumatology - Hospital of Melzo (Milan)* Division of Orthopaedics and Traumatology, Ospedale S. Raffaele (Milan)

ABSTRACT

The authors were treating 27 patients, presenting skin lesions with loss of superficialsubstance on the trunk (6 cases), on one of upper limbs (15 cases), on one of thelower limbs (6 cases). The origin of the lesions was traumatic in 25 of the treatedcases, post-operative in the other two.

Wound debridement and cleansing were followed by the application on all the surfaceof collagen soft sponges 5x5x0.5 cm. (CONDRESS), in sufficient number to cover theloss of substance.The medication with heterologous collagen was able to promote and accelerate thetissue repair also in non-ideal situations (wounds not completely cleansed, irregularedges, suspect secretion): the application of collagen stimulated granulation andconcurred in achieving the repair of the loss of substance.In deep lesions the repair filled quickly the cavity, then tended to go above theepidermal level with hypertrophic granulation tissue.Compared to treatment with current medications, the loss of substance repaired inshorter time. In cases where the comparison was possible (same subject, similar

lesions, depth and characteristics) collagen, compared to other medications asdescribed, filled faster the loss of substance. The medication with collagen, createdalso a valid barrier to superficial infections. Although we never used antiseptictreatment no superficial infection of the lesions took place.


8/24


8

COLLAGEN IN ORTHOPEDY AND TRAUMATOLOGY

G. Soncini, E. RinaldiOrthopaedics and Traumatology Clinics Institute – University of the Studies, Parma

Abstract

The authors were testing the efficacy of collagen in order to verify if its applicationcould accelerate or reduce cicatrization of lesions in orthopedics and traumatologywhere there are several clinical situations requesting a fast cover of the skin and

optimum healing of tissue solution of continuity.The collagen in form of soft sponges of different sizes or in form of films or as amicrofibrillate powder was, after wound detersion, applied every 3 days on the loss ofsubstance and fixed with gauzes and plasters. Both general and local tolerability wereevaluated with laboratory tests.At the Orthopedic Clinic 59 patients were treated with the collagen sponges, somehospitalized and some in casualty department. Out of these, 32 were periodicallyfollowed until complete healing, 19 were males and 13 females, aged between 16 and97 years (mean 55.5 years) affected by loss of soft tissue provoked by accidentaltraumatic lesions (15 cases) or car accidents (13 cases). 4 patients presented legulcers caused by obstructing vasculopathy.The clinical results have been considered “excellent” in 15 cases having achievedcomplete cover of the wound, “good” (14 cases) for a reduction of the surface of thelesion and growth of granulation tissue, “poor” (3 cases) with an unchanged status ofthe lesion. These last three cases were complex ones (one case of myelopathy withsacral fistules, one paraplegia with ischial ulcers, one case with extremely large glutealdecubitus and trochanteric ulcers).The results achieved are considered highly positive considering the seriousness of thelesions. The average application period of collagen was of 36 days (min. 10, max 87)whereas the healing time was ranging between 10 and 113 days with an average of43.The use of collagen induced a significant improvement of the tissue repair process.The sponge is handy, it is very well tolerated and never induced side effects.

The final results are more than satisfactory both for the time of healing (average 36days) and for the quality of the scar.


9/24


10/24


11/24


11

CLASSIFICATION OF VASCULAR ULCERS. TREATMENT OF VASCULAR ULCERSWITH HETEROLOGOUS COLLAGEN

C. Corsi, S. GiordanoAngiology Functional Unit Santa Chiara Hospital - Florence

Abstract

The authors made an extensive classification and description of different types ofulcers.The soft collagen sponge was applied after detersion and bacterial control of thelesion, to exclude infection, and fixed with protective bandage (elastocompressive in

patients with venous pathology).Ulcers were controlled every two days to observe possible lysis of the sponge whichwas replaced partly or totally in case it resulted destroyed by lysosomial enzymes ofthe granulation tissue cells.In some cases antibiotic was administered locally, having noted that the spongeretains the liquid without modifying the properties of the collagen (Fig. 9-10-11)The healing of almost all venous ulcers was obtained, the fast improvement of theischemic and mixed ulcers was also achieved (tab. VIII).In one case an infection from Gram-neg was noted; in the other two cases pain tookplace after collagen application but there were no skin reactions from sensitizationsuch as erythema or edema.

The evaluation of the efficacy of collagen was made on the basis of clinical, objectiveand subjective parameters.Pain was evaluated, studying the characteristics, burning, paresthesia or itching.Exudate, periulcerous erythema, edema, granulation tissue were also evaluated.Based on our experience it can be stated that heterologous collagen represents a validdrug for the therapy of ulcers of any origin. It showed particularly efficacious instimulating granulation process and induce re-epithelialization of the lesions.


12/24


1122

OUR EXPERIENCE IN THE TREATMENT OF TROPHIC LESIONS OF LOWER

LIMBS USING HETEROLOGOUS COLLAGEN B. Borreani, L. Brizio, A. Mannari, F. ToniuttiXIII U.S.L. GE-4 Division of Vascular SurgeryU.S.L. N. 3 Consultancies on Angiology and Vascular Surgery

Abstract

The Authors highlight the use of heterologous collagen Condress in the treatment oftrophic lesions of the leg.The trial involved 30 patients of both sexes. The patients were subdivided based ontheir systemic sickness in 3 categories:

- No 10 affected by mixed arterial and venous lesions- No 5 affected by ischemic lesions- No 15 affected by pure phlebostatic venous lesions

The patients were evaluated before starting the treatment by Doppler sonography andin some cases with an angiographic examination in order to find a possible medical orsurgical indication to be performed besides the topical treatment of the lesion.Before starting treatment, the detersion of the trophic lesion was made controlling thesame with culture pads and antibiogram.The ischemic lesions improved leaving dry eschars which, when sometimes removed,

allowed the formation of granulation tissue.Mixed lesions healed in 6 cases only; the remaining kept unchanged.The venous phlebostatic lesions healed completely.In conclusion, the collagen efficacy was demonstrated particularly when associatedwith other medical or surgical therapies.


13/24


14/24


14

USE OF HETEROLOGOUS COLLAGEN (CONDRESS3) IN THE TREATMENT OFMALLEOLAR ULCERS IN THALASSEMIC SUBJECTS

N.G.Cavallesco, G.F.Azzena, L. LupiSpecial Surgical Pathology Institute and Clinical Propaedeutics - University of Ferrara

Abstract

The authors observed 24 patients suffering of thalassemia and affected by malleolarulcers. These 24 patients, 14 males and 10 females, aged between 16 and 35 years,were accurately studied clinically and physiopathologically.The ulcer although always located at the malleolus showed a largely variable sitebeing on the medial or lateral district of one leg or of both. Based on the experiencemade studying post-thrombotic syndrome, the patients were submitted to venouspressure measurements. The first data gathered was a constant hypertension inclinostatism min 5 mmHg, max 24 mmHg with an average of 15/20 mmHg. Another important data was that hypertension in many cases was present also in theother leg, in clinostatism, even in absence of the ulcer. In orthostatism the minimumpressure was 2 mmHg and the maximum was of 6 mmHg with an average of 3.8mmHg; furthermore the authors noticed in the orthodynamic test a complete absenceof pressure reduction in 8 patients, while in the remaining patients there was adecrease of pressure with a curve clearly indicating a good emptying of the superficialcircle. Peculiarity of all recordings is the presence of a curve pulsating in synchrony

with the pulse, both in ortho and clinostatism.Based on rheological modifications and venous hypertone recorded, a therapy wasestablished considering an elastic compression and the use of pentoxifilline which isacting on the plasticity of red blood cells and on their deformability results in animproved microcirculation.To these two therapeutic devices, the use of heterologous collagen (CONDRESS) wasadded for the last series of patients. The application of the product on ulcers is so easythat the patient himself can apply it at home; the total absence of side effects andmainly the speed of healing of the lesions, induced us to extend the use of collagen toall patients under examination.The feeling was that ulcers treated with collagen heal faster (on average a week

before) but what is most important is that all patients reached the complete closure ofthe ulcer. Certainly there are still the obscure aspects of the ulcer pathogenesis inthalassemic patients and the data obtained are sometimes not in accordance and ofdifficult interpretation.For sure the collagen strongly contributed to accelerate the healing of these lesions infaster time and with very simple procedures with great satisfaction for the patient andfor the doctor.

3 CONDRESS is one of the several Euroresearch’s proprietary trade marks (amongst which Biopad Gelfixand Proteita) used to market the same collagen pad


15/24


1155

THE USE OF COLLAGEN IN ANGIOSURGERY

G. de Donato, M. Placino, P. De Nicola

Ospedale Nuovo Pellegrini (New Hospital Pellegrini) - Angiosurgery and CardiostimulationDivision - Naples

Abstract

Trophic lesions of lower limbs can be tied to venous factors (IVC - Post PhlebiticSyndrome), to arterial (ACO) and dysmetabolic factors (diabetes mellitus). Cutaneoushypoxiac sufference in IVC and PPS has its normal location at medial malleolus withextension and conformation of the ulcer extremely variable. Localization as a “sleeve”at the instep or on top of the foot or at lateral malleolus with multiple location are notexcluded.The tissue repair process is due to the formation of bridges of collagen fibrils.It appears therefore rational the topical use of collagen (CONDRESS4) to stimulate therepair of the trophic lesion.From October 1989 to February 1990, 23 patients were selected (10 males, 13females), 49 years old on average (38-63 yeras). All were suffering from trophiclesions on the legs, 6 of them from arterial origin (2 diabetic), 17 from insufficientchronic venous flow. 18 patients had a simple trophic lesion, 3 a double lesion (venousorigin) 2 had multiple phlebostatic ulcers (3 in number).Heterologous collagen has been used with positive results in preclinical tests on albinrats after having induced a dorsal skin ulcer.With the same product the concentration of plasmatic and local fibronectin was

monitored (on the lesion treated with CONDRESS). A large plasmatic reduction wasrecorded and an increase in the site of the lesion, probably for a local bindingphenomenon.Heterologous collagen appears therefore a useful substance to stimulate cicatrisation,being a strong adsorbent of fibronectin that acts as a scaffolding.CONDRESS can be applied directly on the bed of the wound, to act as a stimulator ofconnective growth of granulation, of epithelial migration, as a selective filter forbacteria and air, allowing oxygen exchanges as well as water steam from the bed ofthe wound. During its absorption aminoacids and more complex molecules metabolizein situ, therefore the properties of the compound can be considered fully physiologic.At the control medications every 3 days a constant finding was the complete lysis of

the unit previously applied. One patient with a painful lesion healed already after 10days.The best results were recorded with the group of phlebopathics. In the subjects withsingle lesion from IVC the healing took place for all the patients. Also patients withdouble lesion healed completely at the control made at 56 days. In the group treatedwith CONDRESS the healing occurred in all cases (3 patients) at the control at 14days.Based on our experience we believe that the use of heterologous collagen CONDRESSis a valid support in the treatment of trophic lesions caused by bad vascularization,once that preliminarily the correction of the cause has been performed.

4 CONDRESS is one of the several Euroresearch’s proprietary trade marks (amongst whichBiopad, Gelfix and Proteita) used to market the same collagen sponge.


16/24


1166

HETEROLOGOUS COLLAGEN IN THE TREATMENT OF SKIN TROPHIC LESIONS: OUR EXPERIENCE

M.Giberto, R.Masini, G.Canova, P.Pramaggiore, M.A.Damerio, G.BecchiGeneral Surgery I Division – Civil Hospital of Genoa Sampierdarena

Abstract

Skin trophic lesions are of high interest in surgery for their frequent occurrence andfor their relevant physio-pathological aspects, which quite often cause a difficultcorrect interpretation and treatment.The availability of a new device - lyophilized collagen soft sponges – gave rise to ahigh interest both in the scientific and in the clinical practice standpoints.This innovative biological material, of natural origin, potentially has all characteristicsof an ideal dressing material; at the same time it results as the main mediator of thetissue repair process. In fact, once extracted, heterologous lyophilized collagenmaintains unchanged the main chemical-physical characteristics of the naturalcollagen as well as its efficacy.The aim of this study was to evaluate the efficacy of the heterologous collagen in formof a soft lyophilized sponge for healing of trophic lesions, treated for 4-6 months andover with traditional devices without obtaining a complete cicatrisation.Initially we included in this study 20 patients, during 6 months, presenting skin trophiclesions of variable origin. Nine patients among them did not complete the study fordifferent reasons and were not considered in the evaluation of results.The remaining 11 patients, 6 males and 5 females average age 69 ± 5 years, in theobservation period August-November 1989, presented skin trophic lesions.Seven out of the 11 patients treated healed completely (63.6%).In 3 cases (27.2%) we obtained an improvement with incomplete healing after 120days of treatment.In 1 case (male, 71 years old, amputated of the right foot caused by obliterant chronicarteriopathy, at the IV Fontaine degree) the conditions of the trophic lesions wereunchanged after 120 days owing to an additional recent bacterial infection. Once thelesion was again sterilized it showed in the last control an improvement with partialcicatrization of the ulcer but this case was considered not successful (9.09%).

On the contrary, the group treated with CONDRESS after 30 days of treatment showeda progressive favourable evolution of the local state, achieving a maximum diameterof the trophic ulcer of 1 cm after 120 days.The data cannot but confirm the efficacy of heterologous collagen in promoting thetissue repair process of skin trophic lesions particularly in cases of difficult healing.The results of our studies confirm the efficacy of heterologous collagen in favouringthe healing process in case of trophic cutaneous lesions. Also in cases of difficulthealing the cicatrisation was successful in 63.6% of cases.This datum joint to the one concerning the percentage of improved lesions (27.2%)brings to 90.8% of positive results.


17/24


1177

PRELIMINARY CLINICAL DATA ON THE USE OF HETEROLOGOUS COLLAGENIN CONTINUALLY SOLUTION SKIN LESIONS

G.Ricotti, M.G.Tucci, *A.Pugnaloni, M.M.Tappa, P.Schreiber, *G.BiaginiClinical Dermatology* Normal Human Morphology Institute - University of Ancona

Abstract

We compared the action of heterologous collagen with that of an hydrocolloid in the

repair of leg ulcers in vasculopathic patients and in the repair of donor's sites.Our aim was to check the difference of healing time but also in quality of the tissuerepaired therefore besides the clinical study we also performed the histological studyin five cases of ulcers and the same was done on donor's sites. The latter wasperformed to evaluate the tissue repair in areas not suffering vascular pathology.Selection included both sexes, age between 15 and 80 years, in total absence of anyother pathology such to influence the tissue repair process. Therefore patientsunderwent a general clinical and laboratory control before being admitted to thestudy. Patients with crural ulcers were submitted to eco-doppler of legs. In patientswith two monolateral crural ulcers collagen was applied on the ulcer located moredistally; patients with large ulcers had the half ulcer proximal treated withhydrocolloids and the half distal with collagen. In the two patients with donor's site,the donor's site was treated half with collagen and half with a greasy gauze instead ofhydrocolloid. All ulcers were cleansed and disinfected. Sterilization of the lesions wascontrolled by bacteriological analysis of the bottom of the ulcer. In patients who wereto be submitted to histological control a biopsy of the edges and of the bottom of theulcer was performed to evaluate the original conditions and to allow a comparisononce the treatment started.After one month and after three months from treatment a biopsy was performed. Softsponges of collagen were applied in double and triple layer after being wet withgentamycin and the biological medication was covered with a gauze.The hydrocolloid was applied according to the usual directions of the product (granulesand adhesive pad).Histological data show more clearly an exuberance of epithelium, larger regenerationof connective, larger mesenchymal cellularity in the treated areas with collagen wherethe layer of collagen fibers seems to have a more orderly distribution and wherephlogosis is lower.It seems to us early to get anatomic-clinical conclusive considerations on the efficacyof collagen in the tissue repair process generally speaking, but we believe to be ableto affirm that the selection of this material represents an advanced moment in therepair process and and healing, even when is not faster, is certainly morephysiological.


18/24


18

TOPICAL THERAPY OF VENOUS ULCERS WITH HETEROLOGOUS COLLAGEN

R.Del Guercio, A.Niglio, R.Miranda, M.Del Guercio*, G.SicilianoChair and Department of Angiology - Medicine I - University of Naples*Clinical Medicine and Nephrology Institute University of Naples

Abstract

A study on 20 patients with venous chronic leg ulcer was performed.Patients were checked clinically, the aspect of the ulcer evaluated and size measured.Detersion and sterilization of the ulcer was made before starting treatment andrepeated until the ulcer was no more polluted.

The evaluation of results after the repeated medications was made after 7, 30 and 60days.During this period of time it was recommended to patients to follow the hygienic rulesgiven according to the venous pathology present.On all treated patients no local or generalized allergy occurred, showing the goodtolerability of the dressing.Referring to the results, exception made for 2 cases, the other 18 cases resultedpositive. A complete disappearance of symptoms and a progressive reduction of theulcer was observed.Collagen was largely tolerated by all patients. In all patients an efficient push tocicatrization was obtained.90% of cases (18 on 20) reached complete healing in a period of 60 days ofobservation.In particular 7 patients (35%) achieved healing within 30 days, 11 (or 55%) within 60days.In the two patients who after 60 days did not completely heal, the reduction of thesize of the ulcer was reached and they were expected to heal completely later on. Nopatient suffered infections signs (sponges totally saturated by exudate) but for 20% ofthem (14) after 2 days from application signs of favourable response of the vitaltissues (mixture of sponges with the bottom of the ulcer) were noted.In the remaining 6 patients (30%) the sponges were unchanged after 2 days,adhering to the bottom of the lesion and without macroscopic signs of favourableresponse.

Non denaturated collagen is a wound healing dressing with high efficacy whencorrectly applied. In particular the lesion must be cleansed and sufficiently sterile.Excess of germ presence besides hindering or not allowing healing may provoke, dueto enzymes liberated by the germs the lysis of the collagen sponge with consequentinefficacy of the same.It can be concluded that the use of collagen to treat chronic phlebostatic ulcers, oncecorrectly made, is efficient, well tolerated, appreciated by patients also for the easyway the medication is perfomed and the fast response to the treatment.


19/24

EURORESEARCH s.r.l. IST Ed.1 Rev. 1-MR1

19

OUR EXPERIENCE ON MORE THAN 2000 CASES OF ULCERS TREATED WITHHETEROLOGOUS LYOPHILIZED COLLAGEN

B.PalmieriChair of Surgical Semeiotics - University of Modena

Abstract

The availability, in the last 15 years, of soft sponges of heterologous lyophilizedcollagen allowed an increase its use also in consulting rooms for the treatment ofwounds and ulcers.

The clinical cases studied by the Authors include 2796 patients treated in consultingrooms or hospitalized at the Clinica Chirurgica Istituto Policattedra from 1985 to 1989.

Globally 5 controlled studies for 112 patients were performed, comparing collagen withgauze with dextranomer (72 cases) or hydrocolloid (40 cases).The 72 cases were studied against control comparatively, while 40 cases were studiedby comparing in the same ulcer the adjuvant effect of collagen against hydrocolloidsplitting the area to be treated in 2 symmetrical semicircles and considering thereduction of size by encroaching of the edges towards the center in both areas treatedwith different compounds.The control therapy without comparison product started only after an accurate surgicaldetersion (with instruments home made and used for several years) or with a medicalcleansing treatment with dry gauzes and wrapper of low alkaline solutions. In case of ischemic disease of legs, the treatment was performed together withmedical vasoactive therapies or revascularization whenever possible.In cases of diffused arteriosclerosis, the application of collagen was anyway animportant therapeutic moment. In venous return pathology static and dynamic dopplerexamination and phlebography were performed. Whenever xrays advised it, theLynton intervention was performed interrupting the insufficient vessels.The treatment with collagen of venous ulcers has shown to be of therapeuticimportance: from one side in fact it has been possible to treat bleeding venous ulcersin emergency taking advantage of the strong haemostatic effect of the product, on theother side to induce faster a good granulation tissue.In venous insufficiency a fixed compressive bandage, non removable, was appliedlimiting the mobility of the patients for 5-10 days, during which the treatment wasoptimized based on the time of dissolution of the product.

For decubitus ulcers the patients were mobilized every hour, the anti-decubitusdevices were used as well as a string bleeding detersion and drainage applied in themost serious cases. Also exposition of ulcers to sun or ultraviolet rays to reduce themicrobial charge, was used.Burns were treated with collagen opening to air the burned bottom of deepteguments.Actinic ulcers were the most torpid and those in which heterologous collagen had lesstime to autolysis.In diabetic foot the maximum effort was made to identify the microbial populationpresent (particularly staphylococcus aureus) and to compensate metabolismadministering insuline.


20/24


20

THE TREATMENT WITH LYOPHILIZED COLLAGEN OF SKIN WOUNDS WITH

LOSS OF SUBSTANCE IN ON FIRST AID UNITSG.Caselli , M.La CavaEmergency Department, Hospital S. Giovanni - U.S.L. RM4 - Rome

Abstract

The aim of this study is to demonstrate the haemostatic and the healing effects ofCONDRESS.The feature and the size of the wounds with loss of substance have been evaluated atthe moment of hospitalization and with subsequent clinical controls. The modalities for

a complete re-epithelialization were then put in evidence.On November 1989 a random therapeutic trial started on patients of both sexesarriving in our surgical First Aid Room with skin wounds with loss of substance.The Authors favoured patients with rather large lesions or multiple lesions in regionsof easier evaluation exempt from vasculopathies, diabetes mellitus or other systemicillnesses. This enabled to perform a more objective evaluation of lesions, theutilization of a ground biologically homogeneous and moreover to treat in the samepatient part of the lesion with lyophilized collagen (CONDRESS) and another part withparaffin gauzes.Since November 1989 until January 1990, 31 male patients were treated (60.7%) and20 females (39.3%) aged between 18 and 60 (avg. 39 years) arrived to the Surgical

First Aid Room with lesions with loss of substance.A comparative study of the results collected every 3 days was performed and at thebeginning of treatment a fair or large reduction of 43 (84.3%) wounds treated withCondress and 21 (41.1%) only of controls with a fair reduction was noted. On the 6thday the results of treatment with Condress were confirmed as well as those of thecontrols: 22 (43.1%) with fair, large reduction. On 9th day 42 (86.2%) woundstreated with Condress (2 were healed) presented a fair or large reduction and 7(14.3%) a moderate one, whereas about half of the controls, (26 = 50.9%), was infair or large reduction. On 12th day the results of treatment with Condress wereunchanged (85.7%) whereas in the wounds treated with paraffin gauze 12 only(23.5%) were in fair or large reduction.On 15th day we had 40 wounds treated with Condress (76.9%) and 46 with paraffingauze (90.1%). Out of the first ones 28 (70%) were in fair or large reduction; out ofthe second ones 14 only (30.4%) were with fair reduction, the remaining withmoderate reduction.This trend was confirmed in the long run so at 18th day only 32 wounds (62.7%)were under treatment with Condress (the other 19 were healed) and 12 (37%) ofthem presented a fair or large reduction.The capacity of collagen to catch and maintain vital and active in the sites of lesionsthe main cells of granulation tissue and its capacity to call from the edges of thewound the cells of the germinative layer of epidermis, later connected to its deeperfibers, constitutes the distinctive characteristics of CONDRESS compared with paraffingauze or other products.


21/24


21

TREATMENT WITH HETEROLOGOUS LYOPHILIZED COLLAGEN (CONDRESS5) OF THE LESIONS OF BEDRIDDEN PATIENTS

G. MOLINARI Ordine Ospedaliero San Giovanni di Dio – Fatebenefratelli - "S. Raffaele Arcangelo" Hospital -Long-term stay and Respiratory Rehabilitation Unit - Venice

Abstract

A serious and common complication of the immobilization of elderly people isrepresented by the decubitus ulcer. A recent study outlined that after 20 days ofconfinement in bed 7%-8% of decubitus ulcer appearance is detected; 50% ofpatients developing ulcers are over 70.In our case history 19 cases hospitalized in the ward for variuos pathologies of

bedridden patient have been treated with Condress. Out of the 19 cases, 6 for fracture(femur, pelvis or rotula) 3 cases of diabetes, 3 pneumonia, 1 amputation of foot fordiabetic gangrene, 1 rheumatoid arthritis, 1 plastics for removal of epithelioma of theleg, 1 angiodermitis of the right foot, 1 cardiac decompensation, 1 myeloma.Three patients died for cardiac and lung complications: 1 after 48 days, 1 after 41, 1after 30. The average age was of 79 years in the range of 54-93 years, mean of 82;the females were 15 and the males 4. Treatment duration was from 30 days to amaximum of 128 days with an average of 55.3 days. Nine cases healed (47.3%), sixgave a good response (31.5%), 4 scarce (21%); out of these latter two had sacrallesions with the bone exposed, one died after 30 days of therapy.Healing percentage in relation with the phase was:

phase 1: 1 case, one healing (100%) phase 2: 8 cases, six healings (75%) phase 3: 8 cases, three healings (37.5%) phase 4: 2 cases, no healing

No side effects nor allergy were detected in any of the patients.The percentages of scarce response (4) were as follows:

phase 1: 1 case, no scarce response phase 2: 8 cases, no scarce response phase 3: 8 cases, two scarce responses (25%) phase 4: 2 cases, two scarce responses (100%)

At the conclusion of our experimentation we would like to state:1) it is unquestionable the usefulness of Condress on ulcers regardless theetiopathogenesis2) it is necessary to intervene as soon as possible at the beginning of ulcer formationbecause the good results are higher in the initial stage3) anyway also in advanced stages of the ulcer better responses are obtainable withCondress collagen as compared with other medications.4) it is also to be noted the optimum tolerability and an absolute lack of general orlocal side effects.



22/24


22

LYOPHILIZED HETEROLOGOUS COLLAGEN AND ITS APPLICATION INDERMOSURGERY: RATIONAL AND RESULTS

L. VERANI, F. BEGHÉ*, A. ZAMPIERI**Dermatology and IST Plastic Surgery Department, Genua*Clinical Research Department Istituto Gentili, Pisa**II Medicine - University of Pisa

Abstract

Transplants of skin and autologous grafts are techniques largely used in all thosecircumstances, secondary to exeresis interventions, where an adequate reconstructionis necessary. Sometimes anatomical causes and the elderly age of the patient, notrecommending long surgery interventions, make the application of these proceduresextremely difficult. The necessity to identify a substitute of fresh autologous tissuecharacterized by high biocompatibility, induced us in this optics to evaluate thepossibility to use an heterologous lyophilized collagen available in soft sponges.CONDRESS6, extracted from hinder tendons by a non denaturating process, is a type Icollagen maintaining its triple helix structure. Various studies confirmed its role as astimulating factor of the tissue repair process both in experimental models and invarious clinical conditions.The aim of the study was to evaluate the efficacy of heterologous collagen assubstitute of autologous fresh tissues based on time of healing, quality of scar andlocal tolerability.116 patients were treated, 70 males and 46 females aged between 23 and 92 (mean70 years).78 patients were affected by basal and spinocellular epitheliomas.The soft sponge of collagen was progressively digested by tissue collagenasis andpresented itself commisted or melted with the bottom of continuity solution. The nextsponge (or sponges) was applied on top of the previous one, whose debris were notremoved at the moment of medication.The tissue repair process took place in optimal way in all the patients treated withCondress. In particular no cheloids or hypertrophic scars were recorded and rare wasthe sinking of the scar. Recovery time was similar to that observed in patients treatedwith autologous implants or skin transplants. No local hypersensitization wasobserved. Periodical bacteriological analyses of the lesions did not detect the

development of a bacterial flora potentially pathogenic and, as a confirmation thereof,no infections were ever recorded.Condress represents a valid alternative to autologous skin transplants andtransposition of edges in surgical dermatology particularly when these procedures aredifficult or when a reduction of the surgery time is required.Based on our experience it can be stated that heterologous collagen has a role ofdressing and at the same time stimulates and optimally modulates the whole tissuerepair process and healing, whose stability was largely verified by prolonged follow-upof these patients.



23/24


23

ONE CASE OF NECROSIS OF THE FOREFOOT

G.Etti di Rodeano

Civil Hospital Avezzano – Plastic Surgery Unit

Abstract

This case involves a female, 65 years old, suffering from iatrogenic necrosis offorefoot. The patient is diabetic, obese and arteriosclerotic.

TOPICAL TREATMENT OF DIABETIC TROPHIC ULCERS USING HETEROLOGOUSCOLLAGEN (CONDRESS7)

L.Granata, M.Caviglia, A.Battistini, G.L.Viviani, L.AdezatiGeneral Medicine Clinics and Medical Therapy III – Scientific Institute of Internal Medicine –University of Genoa

Abstract

Trophical ulcers of lower limbs represent a frequent outcome of diabetes mellitus and

often cause hospitalization.Notwithstanding the multiple etiology (macroangiopathy, microangiopathy,neuropathy, phlebopathy) that requires complex systhemic therapies, the topicaltreatment is necessary and consists in cleansing of the lesion and spur to cicatrisation.In the absence of infections it is easy to reach the goal; however very often healingshows a sluggish trend.In these conditions the topical use of collagen represents an efficacious helpTo evaluate the efficacy of collagen, the authors used it in three cases characterizedby trophic ulcers with torpid trend.At the beginning of the treatment the ulcers were cleansed and sterile.The collagen pad (Condress) was shaped at necessity, applied on the ulcer andcovered by a wet gauze and bandage to keep it on place.Dressings were performed daily.The ulcer was cleansed of essudates and collagen residuals using sterile saline.In case of horny edges a surgical toilette was performed.Condress proved to be very efficacious in promoting cicatrisation of cleansed trophiculcers.During treatment no undesired side effects or allergic reactions took place.The easiness of use make Condress suitable to the home use too, peculiarity veryimportant in case of long-term treatments.

7 CONDRESS is one of the several Euroresearch’s proprietary trade marks (amongst which BiopadGelfix and Proteita) used to market the same collagen pad


24/24


24

THE USE OF MICROAUTOSKINGRAFTS IN THE TREATMENT OF WIDEPRESSURE ULCERS: OUR EXPERIENCE

P.Ziccardi, G.Esposito, G.Di Caprio, M.Scioli and N.Scuderi*Foundation Labour Clinics.Morphofunctional rehabilitation Section in Plastics Surgery Unit.Medical Centre Campoli M.T.-I.R.C.S.S. (Benevento Italy)* Plastics Surgery Chair – University “La Sapienza”, Rome

Abstract

The surgical treatment of wide pressure ulcers is generally performed using nearbyedges or myocutaneous skin. Unfortunately it is not always possible to treat thesepatients that are generally very run down and in very poor general conditions.The skingraft too can be performed on pressure ulcers but it does not represent theoptimal therapy since, having to implant large areas of loss of substance, the skinremoval would be so large to considerably increase the disepithelialized area and, incase of failure of the graft, it would surely cause a worsening in the conditions of thepatient. So far we treated 12 patients, all suffering from sacral pressure sores, with avariable surface between 25 and 45 sq cm.In all patients we took very limited amounts of thin skin-grafts, in order not toprovoke an increase of the damaged area.

A surgical courettage of the ulcers was made, to eliminate hypertrophic granulations;in some cases the toilette was performed using a dermal scraper.In the last 4 patients, we replaced the homografts with CONDRESS, heterologouscollagen. A compressive dressing has been made and removed at 48 hours, aftercontrol of the successful implant.The patients were positioned to avoid decubitus on the grafter area during 10 daysafter the intervention and, possibly, even more.The microautoskingrafts positioned on the damaged areas were successful in about80% of the treated patients.The complete recovery took place between 42 and 57 days from intervention.After about 10 days from grafting the implants started to spread, with a tendency tocome together and reaching a size 4-5 times higher than the original.It has to be highlighted that the most recent 4 cases treated with CONDRESS healedmore quickly, with a faster growth of the grafts compared to the other patients andreducing the total recovery time.The favourable results achieved encourage to the use of this technique.

Biopad biospray

Documents