Methodological choices for the clinical development of medical devices.

Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD.

Dressings for acute and chronic wounds: a systematic review.

Objective: To critically review the literature on the efficacy of modern dressings in healing chronic and acute wounds by secondary intention.

Data Sources: Search of 3 databases (MEDLINE, EMBASE, and the Cochrane Controlled Clinical Trials Register) from January 1990 to June 2006, completed by manual research, for articles in English and in French.

Study Selection: The end points for selecting studies were the rate of complete healing, time to complete healing, rate of change in wound area, and general performance criteria (eg, pain, ease of use, avoidance of wound trauma on dressing removal, ability to absorb and contain exudates).

Consensus panel recommendations for chronic and acute wound dressings.

Objective: To seek a consensus on recommendations that would help health professionals choose appropriate wound dressings in daily practice, since a systematic review found only limited evidence to support reported indications for modern wound dressings.

Participants: A steering committee selected a panel of 27 experts with no declared conflicts of interest from lists of nursing staff and physicians (specialists or general practitioners) with long-standing experience of wound care. The lists were put forward by 15 French learned societies.