Clinical trial NCT01036438: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Leg Ulcers
Mixed Leg Ulcers
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy Will be Defined as Absolute Wound Size Reduction.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Inflammatory Signs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Fakultní nemocnice U svate Anny, St. Anne´s University Hospital
city: Brno
country: Czech Republic
facility: Dermatovenerologická klinika, University Hospital Bohunice,
city: Jihlava
country: Czech Republic
facility: Nemocnice Jihlava
city: Liberec
country: Czech Republic
facility: Krajská nemocnice Liberec
city: Plzen
country: Czech Republic
facility: Dermatovenerologická klinike, Univerzita Karlova
city: Prague
country: Czech Republic
facility: Fakultní nemocnice Na Bulovce
city: Praha
country: Czech Republic
facility: chirugické oddělení, Fakultní nemocnice Královské Vinohrady
city: Třinec
country: Czech Republic
facility: Nemocnice Podlesí a.s.
city: Uherské Hradiště
country: Czech Republic
facility: Uherskohradišťská nemocnice a. s.
city: Usti nad Labem
country: Czech Republic
facility: Masarykova Hospital, Dermatology dept.
city: České Budějovice
country: Czech Republic
facility: Dermatovenerologie Rendlová s.r.o.
city: Amiens cedex
country: France
facility: Dermatology Department, University Hospital, Hopital Sud
city: Amiens
country: France
facility: Polyclinique de Picardie Service d'Angiologie Phlébologie
city: Antony
country: France
facility: Hôpital privé d'Antony Service de Dermatologie
city: Besançon
country: France
facility: Hôpital Saint Jacques - CHU Besançon
city: Boulogne-sur-mer
country: France
facility: Résidence le Bristol
city: Caen cedex 9
country: France
facility: Service de Dermatologie, Centre Hospitalier Regional Universitaire
city: Dijon Cedex
country: France
facility: CHU Le Bocage Service Dermatologie
city: Grenoble Cedex 9
country: France
facility: Hôpital Albert Michallon Service de médecine vasculaire
city: La Roche-sur-Yon
country: France
facility: CHG La Roche-sur-Yon Service de D'Angiologie,Les Oudairies
city: Le Mans cedex 9
country: France
facility: Centre Hospitalier le Mans Service de Dermatologie
city: Lille
country: France
facility: Cabinet D'Angeiologie
city: Nancy
country: France
facility: Hopital Maringer-Villemin- Fournier
city: Nantes
country: France
facility: Pharmacie Centrale-Service Arsenal
city: Paris
country: France
facility: APHP Hôpital Lariboisère
city: Paris
country: France
facility: Hôpital Rotchild - Jean Rostand
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Reims
country: France
facility: Hopital Robert Debré Service de Dermatologie
city: Rouen cedex
country: France
facility: Hopital Charles Nicolle
city: St Alban
country: France
facility: Cabinet d'Angiologie, 1 bis rue de Salgareda
city: Talence Cedex
country: France
facility: Maison de Santé Protestante de Bordeaux-Bagatelle
city: Thionville
country: France
facility: Hopital Beauregard / Secrétariat de Dermatologie
city: Toulon cedex
country: France
facility: Service de dermatologie
city: Toulouse
country: France
facility: Clinique Pasteur
city: Berlin
country: Germany
facility: Universtätsmedizin Charité Klinik für Dermatologie, Allergologie und Venerologie
city: Bochum
country: Germany
facility: Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken -
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppedorf
city: Hamburg
country: Germany
facility: Bramfelder Chaussee 200
city: Jena
country: Germany
facility: Universität klinikum Jena, Klinik für dermatologie und dermatologische
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Tübingen
country: Germany
facility: Universitäts-Hautklinik
city: Amsterdam
country: Netherlands
facility: Dermatology department
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
affiliation: Hopital Rotchild - Jean Rostand, Paris
name: Sylvie Meaume, Dr
role: PRINCIPAL_INVESTIGATOR
References: