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

NCT01036438 | Completed Phase 4 Results

• 1 other identifier: PUMA 416
• Study Type: interventional
• Target: 201
• Locations: 4 countries
• Sites: 44

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

Outcome Measures

Primary Outcomes (1)

• Efficacy Will be Defined as Absolute Wound Size Reduction.

  Efficacy will be defined as absolute wound size reduction.

  8 weeks

Secondary Outcomes (1)

• Change in Inflammatory Signs

  4 weeks

Study Arms (2)

Mepilex product

PLACEBO COMPARATOR

Device: Mepilex without Ag

Mepilex Ag

ACTIVE COMPARATOR

Device: Mepilex Ag

Interventions

Mepilex Ag 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

Mepilex without Ag 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 product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed
• Infected wounds in need of systemic antibiotic treatment
• Previous treatment with MepilexAg® on the target ulcer
• Use of systemic antibiotics for any reason during the previous 7 days
• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (44)

Nemocnice Jihlava

Jihlava, Jihlava, 586 01, Czechia

Location

Krajská nemocnice Liberec

Liberec, Liberec, 46063, Czechia

Location

chirugické oddělení, Fakultní nemocnice Královské Vinohrady

Prague, Prague, 10 PSČ 100 34, Czechia

Location

Nemocnice Podlesí a.s.

Třinec, Třinec, 73961, Czechia

Location

Uherskohradišťská nemocnice a. s.

Uherské Hradiště, Uherské Hradiště, 68668, Czechia

Location

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

Brno, 65691, Czechia

Location

Dermatovenerologická klinika, University Hospital Bohunice,

Brno, Czechia

Location

Dermatovenerologická klinike, Univerzita Karlova

Pilsen, 305 99, Czechia

Location

Fakultní nemocnice Na Bulovce

Prague, 180 00, Czechia

Location

Masarykova Hospital, Dermatology dept.

Ústí nad Labem, 401 13, Czechia

Location

Dermatovenerologie Rendlová s.r.o.

České Budějovice, České Budějovice, 37001, Czechia

Location

Polyclinique de Picardie Service d'Angiologie Phlébologie

Amiens, Amiens, 80000, France

Location

Hôpital privé d'Antony Service de Dermatologie

Antony, Antony, 92160, France

Location

Hôpital Saint Jacques - CHU Besançon

Besançon, Besançon, 25030, France

Location

Résidence le Bristol

Boulogne-sur-Mer, Boulogne-sur-mer, 62200, France

Location

CHU Le Bocage Service Dermatologie

Dijon, Dijon Cedex, 21079, France

Location

Hôpital Albert Michallon Service de médecine vasculaire

Grenoble, Grenoble Cedex 9, 38 043, France

Location

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

La Roche-sur-Yon, La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier le Mans Service de Dermatologie

Le Mans, Le Mans Cedex 9, 72037, France

Location

Pharmacie Centrale-Service Arsenal

Nantes, Nantes, 44093, France

Location

APHP Hôpital Lariboisère

Paris, Paris, 75010, France

Location

Hôpital Saint Joseph

Paris, Paris, 75014, France

Location

Cabinet d'Angiologie, 1 bis rue de Salgareda

Saint-Alban, Saint Alban, 31140, France

Location

Dermatology Department, University Hospital, Hopital Sud

Amiens, 80054, France

Location

Service de Dermatologie, Centre Hospitalier Regional Universitaire

Caen, 140 33, France

Location

Cabinet D'Angeiologie

Lille, 690 00, France

Location

Hopital Maringer-Villemin- Fournier

Nancy, France

Location

Hôpital Rotchild - Jean Rostand

Paris, 75012, France

Location

Hopital Robert Debré Service de Dermatologie

Reims, France

Location

Hopital Charles Nicolle

Rouen, France

Location

Maison de Santé Protestante de Bordeaux-Bagatelle

Talence, France

Location

Hopital Beauregard / Secrétariat de Dermatologie

Thionville, 57100, France

Location

Service de dermatologie

Toulon, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany, 23538, Germany

Location

Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie

Berlin, 10117, Germany

Location

Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -

Bochum, 44805, Germany

Location

Universitätsklinikum Hamburg-Eppedorf

Hamburg, 20246, Germany

Location

Bramfelder Chaussee 200

Hamburg, 22177, Germany

Location

Universität klinikum Jena, Klinik für dermatologie und dermatologische

Jena, 07740, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Universitäts-Hautklinik

Tübingen, 72076, Germany

Location

Dermatology department

Amsterdam, 1081, Netherlands

Location

St. Antonius Ziekenhuis

Utrecht, Netherlands

Location

Results Point of Contact

• Title: Ann Larkö
• Organization: Molnlycke Health Care AB

ann.larko@molnlycke.com

+46 722 3338

Study Officials

• Sylvie Meaume, Dr

  Hopital Rotchild - Jean Rostand, Paris

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2013-12

Locations

DE (8); NL (2); FR (23); CZ (11)