CompletedPhase 3

Dermal Substitute and Topical Negative Pressure in Burns

Netherlands86 participantsStarted 2007-10

Plain-language summary

The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months. Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients \>=18 yrs with acute burns/trauma wounds that require skin grafting * Minimal study wound surface 10 cm2 * Maximal study wound surface 300 cm2 * Maximal TBSA 15% full thickness wounds * Informed consent Exclusion Criteria: * Patients with wounds without adequate possibility to apply VAC * Immunocompromised patients * Infected wounds * Pregnant patients * Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).

What they're measuring

skin elasticity parameters (representing scar quality)

Timeframe: after 3 months

Trial details

NCT IDNCT00548314

SponsorAssociation of Dutch Burn Centres

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05

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