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

Venous Leg Ulcers Clinical Trial

Official title:

A Double-blind, Comparative, Superiority, Multi-centre Investigation 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036438
• Other study ID #: PUMA 416
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2009
• Last updated: September 11, 2014
• Start date: December 2009
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Mixed Leg Ulcers
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Czech Republic	Dermatovenerologická klinika, University Hospital Bohunice,	Brno
Czech Republic	Fakultní nemocnice U svate Anny, St. Anne´s University Hospital	Brno
Czech Republic	Dermatovenerologie Rendlová s.r.o.	Ceské Budejovice
Czech Republic	Nemocnice Jihlava	Jihlava
Czech Republic	Krajská nemocnice Liberec	Liberec
Czech Republic	Dermatovenerologická klinike, Univerzita Karlova	Plzen
Czech Republic	Fakultní nemocnice Na Bulovce	Prague
Czech Republic	chirugické oddelení, Fakultní nemocnice Královské Vinohrady	Praha
Czech Republic	Nemocnice Podlesí a.s.	Trinec
Czech Republic	Uherskohradištská nemocnice a. s.	Uherské Hradište
Czech Republic	Masarykova Hospital, Dermatology dept.	Usti nad Labem
France	Polyclinique de Picardie Service d'Angiologie Phlébologie	Amiens
France	Dermatology Department, University Hospital, Hopital Sud	Amiens cedex
France	Hôpital privé d'Antony Service de Dermatologie	Antony
France	Hôpital Saint Jacques - CHU Besançon	Besançon
France	Résidence le Bristol	Boulogne-sur-mer
France	Service de Dermatologie, Centre Hospitalier Regional Universitaire	Caen cedex 9
France	CHU Le Bocage Service Dermatologie	Dijon Cedex
France	Hôpital Albert Michallon Service de médecine vasculaire	Grenoble Cedex 9
France	CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies	La Roche-sur-Yon
France	Centre Hospitalier le Mans Service de Dermatologie	Le Mans cedex 9
France	Cabinet D'Angeiologie	Lille
France	Hopital Maringer-Villemin- Fournier	Nancy
France	Pharmacie Centrale-Service Arsenal	Nantes
France	APHP Hôpital Lariboisère	Paris
France	Hôpital Rotchild - Jean Rostand	Paris
France	Hôpital Saint Joseph	Paris
France	Hopital Robert Debré Service de Dermatologie	Reims
France	Hopital Charles Nicolle	Rouen cedex
France	Cabinet d'Angiologie, 1 bis rue de Salgareda	St Alban
France	Maison de Santé Protestante de Bordeaux-Bagatelle	Talence Cedex
France	Hopital Beauregard / Secrétariat de Dermatologie	Thionville
France	Service de dermatologie	Toulon cedex
France	Clinique Pasteur	Toulouse
Germany	Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie	Berlin
Germany	Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -	Bochum
Germany	Bramfelder Chaussee 200	Hamburg
Germany	Universitätsklinikum Hamburg-Eppedorf	Hamburg
Germany	Universität klinikum Jena, Klinik für dermatologie und dermatologische	Jena
Germany	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck
Germany	University Hospital Regensburg	Regensburg
Germany	Universitäts-Hautklinik	Tübingen
Netherlands	Dermatology department	Amsterdam
Netherlands	St. Antonius Ziekenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Will be Defined as Absolute Wound Size Reduction.	Efficacy will be defined as absolute wound size reduction.	8 weeks	No
Secondary	Change in Inflammatory Signs	Change in inflammatory signs	4 weeks	No