Clinical evaluation of a dressing with poly absorbent fibres and a silver matrix for managing chronic wounds at risk of infection: a non comparative trial.
OBJECTIVE
To assess the efficacy, safety and acceptability of a new silver poly absorbent dressing (UrgoCleanAg) in the local management of exudative chronic wounds at risk of infection, with inflammatory signs suggesting heavy bacterial load.


METHODS
This prospective, multicentre, non-comparative clinical trial was conducted in French hospital wards (dermatology and vascular medicine) or specialised private-practice physicians. Patients were considered at high-risk of infection when presenting with at least three of five selected inflammatory clinical signs, suggesting a heavy bacterial load (pain between two dressing changes, erythema, oedema, malodorous wound and presence of a heavy exudate). They were treated for a maximum period of four weeks, and followed by the physician on a weekly basis, including a clinical examination, area tracings and photographs. The primary efficacy criterion of the trial was the relative wound surface area reduction at the end of the four weeks of treatment. Acceptability was documented by the nursing staff at each dressing change between the weekly evaluations.


RESULTS
We recruited 37 patients with chronic wounds. Wound surface area, mostly covered by sloughy tissue, was reduced by 32.5% at the end of the treatment (median value), while the clinical score (maximum value of 5, based on inflammatory clinical signs) decreased from 4.0 to 2.0. Effective debridement properties were documented (62.5% relative reduction of sloughy tissue at week 4; 58.8% of debrided wounds at week 4) and improvement of the periwound skin status was noted (healthy for 28.6% of the patients at week 4 versus 2.7% at baseline). In addition, the tested wound dressing presented a good safety profile associated to a high level of acceptability, noted by both patients and nursing staff.


CONCLUSIONS
These clinical data support that the tested dressing is a credible therapeutic alternative for the management of chronic wounds at risk of infection with inflammatory signs suggesting heavy bacterial load.
Dermatology Department. Bocage University Hospital. Dijon. France.
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Dalac
Head of Dermatology Department, Victor Dupouy Hospital. Argenteuil. France.
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Sigal
Department of Vascular Medicine. Edouard Herriot Hospital. Lyon. France.
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Addala
Vascular Physician, Angiologist, Corentin Celton Hospital. Paris. France.
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Chahim
Angiologist, Wound Healing Center. General Hospital. Saint Gaudens. France.
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Faivre-Carrere
Clinical Research Department. Laboratoires Urgo. Chenôve. France.
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Lemdjadi
Medical Director, Laboratoires Urgo. Chenôve. France.
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Bohbot
D058491:Bacterial Load; D047070:Bandages, Hydrocolloid; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012834:Silver / Q000494:pharmacology*; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology; D014946:Wound Infection / Q000382:microbiology / Q000517:prevention & control*; D014947:Wounds and Injuries / Q000382:microbiology / Q000628:therapy*
D012834:Silver
clinical trial; inflammatory signs; risk of infection; silver dressing; venous leg ulcers