Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

NCT ID: NCT01036438

Last Updated: 2014-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-10-31

Brief Summary

Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

Conditions

Venous Leg Ulcers; Mixed Leg Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mepilex product

Group Type: PLACEBO_COMPARATOR

Mepilex without Ag

Intervention Type: DEVICE

Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.

Mepilex Ag

Group Type: ACTIVE_COMPARATOR

Mepilex Ag

Intervention Type: DEVICE

Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.

Interventions

Mepilex Ag

Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.

Intervention Type: DEVICE

Mepilex without Ag

Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an ABPI ≥ 0,8 and < 1.3
• A history of an appropriate compression therapy for at least 2 weeks prior to randomisation
• Subjects with colonised/local infection presenting with three of five following specified signs:

• pain between dressing changes
• exuding wounds
• erythema on peri-wound skin
• oedema
• odour
• An ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm.
• Ulcer duration 6 weeks to 1 year
• In case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers.
• Both gender with an age ≥ 18 years
• Signed informed consent

Exclusion Criteria

• > 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
• Infected wounds in need of systemic antibiotic treatment
• Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
• Previous treatment with silver product 2 weeks prior to inclusion
• Previous treatment with MepilexAg® on the target ulcer
• Use of systemic antibiotics for any reason during the previous 7 days
• Venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion
• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation
• Subjects with poorly controlled diabetes mellitus i.e. HbA1c >8%
• Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Subjects inhaling glucocorticosteroids for asthma should not be excluded.
• Known allergy/hypersensitivity to any of the components of the investigation products.
• Subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition
• Participation in other clinical investigation(s) within 1 month prior to start of the investigation.
• Previously randomised to this investigation.
• Life expectance of the subject less than 3 months
• Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Meaume, Dr

Role: PRINCIPAL_INVESTIGATOR

Hopital Rotchild - Jean Rostand, Paris

Locations

Nemocnice Jihlava

Jihlava, Jihlava, Czechia

Krajská nemocnice Liberec

Liberec, Liberec, Czechia

chirugické oddělení, Fakultní nemocnice Královské Vinohrady

Prague, Prague, Czechia

Nemocnice Podlesí a.s.

Třinec, Třinec, Czechia

Uherskohradišťská nemocnice a. s.

Uherské Hradiště, Uherské Hradiště, Czechia

Fakultní nemocnice U svate Anny, St. Anne´s University Hospital

Brno, , Czechia

Dermatovenerologická klinika, University Hospital Bohunice,

Brno, , Czechia

Dermatovenerologická klinike, Univerzita Karlova

Pilsen, , Czechia

Fakultní nemocnice Na Bulovce

Prague, , Czechia

Masarykova Hospital, Dermatology dept.

Ústí nad Labem, , Czechia

Dermatovenerologie Rendlová s.r.o.

České Budějovice, České Budějovice, Czechia

Polyclinique de Picardie Service d'Angiologie Phlébologie

Amiens, Amiens, France

Hôpital privé d'Antony Service de Dermatologie

Antony, Antony, France

Hôpital Saint Jacques - CHU Besançon

Besançon, Besançon, France

Résidence le Bristol

Boulogne-sur-Mer, Boulogne-sur-mer, France

CHU Le Bocage Service Dermatologie

Dijon, Dijon Cedex, France

Hôpital Albert Michallon Service de médecine vasculaire

Grenoble, Grenoble Cedex 9, France

CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies

La Roche-sur-Yon, La Roche-sur-Yon, France

Centre Hospitalier le Mans Service de Dermatologie

Le Mans, Le Mans Cedex 9, France

Pharmacie Centrale-Service Arsenal

Nantes, Nantes, France

APHP Hôpital Lariboisère

Paris, Paris, France

Hôpital Saint Joseph

Paris, Paris, France

Cabinet d'Angiologie, 1 bis rue de Salgareda

Saint-Alban, Saint Alban, France

Dermatology Department, University Hospital, Hopital Sud

Amiens, , France

Service de Dermatologie, Centre Hospitalier Regional Universitaire

Caen, , France

Cabinet D'Angeiologie

Lille, , France

Hopital Maringer-Villemin- Fournier

Nancy, , France

Hôpital Rotchild - Jean Rostand

Paris, , France

Hopital Robert Debré Service de Dermatologie

Reims, , France

Hopital Charles Nicolle

Rouen, , France

Maison de Santé Protestante de Bordeaux-Bagatelle

Talence, , France

Hopital Beauregard / Secrétariat de Dermatologie

Thionville, , France

Service de dermatologie

Toulon, , France

Clinique Pasteur

Toulouse, , France

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany, Germany

Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie

Berlin, , Germany

Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -

Bochum, , Germany

Universitätsklinikum Hamburg-Eppedorf

Hamburg, , Germany

Bramfelder Chaussee 200

Hamburg, , Germany

Universität klinikum Jena, Klinik für dermatologie und dermatologische

Jena, , Germany

University Hospital Regensburg

Regensburg, , Germany

Universitäts-Hautklinik

Tübingen, , Germany

Dermatology department

Amsterdam, , Netherlands

St. Antonius Ziekenhuis

Utrecht, , Netherlands

Countries

Czechia; France; Germany; Netherlands

Other Identifiers

PUMA 416

Identifier Type: -

Identifier Source: org_study_id