Document Detail


Phase 2 study of a new Hydrofiber dressing for superficial chronic or acute wounds.
MedLine Citation:
PMID:  18494437     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the safety and performance of MedicelTulle Dressing (MTD) in subjects with chronic or acute wounds left to heal by secondary intention. METHOD: This 28-day, multi-centre, single-arm clinical study was conducted at seven sites in France. Thirty patients with a chronic (n = 20) or acute wound (n = 10) were treated with MTD and gauze as a secondary dressing. Study treatment lasted 28 days or until healing. RESULTS: Mean baseline wound area was 14.8cm2. There were 103 clinic dressing changes and 220 home dressing changes. Seven adverse events were reported in five subjects, including one treatment-related adverse event of dry scab. No adherence was reported for 66% of clinic dressing changes and 53% of home dressing changes. No trauma was reported for 96% of clinic dressing changes. Mean reduction in wound size was 7.0cm2. CONCLUSION: In this study, MTD demonstrated good safety results. Additional study is warranted to confirm the clinical utility of MTD in the management of chronic or acute wounds left to heal by secondary intention.
Authors:
N Faucher; S Ehrler; F Vin; T Dugré;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of wound care     Volume:  17     ISSN:  0969-0700     ISO Abbreviation:  J Wound Care     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-05-22     Completed Date:  2008-07-11     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9417080     Medline TA:  J Wound Care     Country:  England    
Other Details:
Languages:  eng     Pagination:  180-2, 184, 187     Citation Subset:  N    
Affiliation:
Hôpital Bichat-Claude Bernard, Paris, France. nathalie.faucher@bch.aphp.fr
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Adult
Aged
Aged, 80 and over
Bandages, Hydrocolloid* / adverse effects,  standards
Chronic Disease
Female
Follow-Up Studies
France
Humans
Male
Middle Aged
Pain / diagnosis,  etiology
Pain Measurement
Safety
Severity of Illness Index
Skin Care / adverse effects*,  instrumentation*,  nursing
Wound Healing*
Wounds and Injuries / diagnosis,  etiology,  therapy*
Investigator
Investigator/Affiliation:
Thierry Dugré / ; Solange Ehrler / ; Nathalie Faucher / ; Yves Guiguen / ; Anne Le Pillouet-Prost / ; Philippe Rudondy / ; Pascal Vasseur / ; Fréderic Vin / ; Donalyn Hyland / ; Jonathan N Lathan / ; JoAnn Ottino /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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