Clinical trial NCT00548314: Dermal Substitute and Topical Negative Pressure in Burns
Official title: Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Keywords: Matriderm
Dermal matrix
VAC therapy
Split skin graft
Burns
Scar quality
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 86
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: 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.

Detailed description: The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.

Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.

Eligibility criteria: 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).

Primary outcomes:
measure: skin elasticity parameters (representing scar quality)
timeFrame: after 3 months
Secondary outcomes:
measure: take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)
timeFrame: after 3 months
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
state: Noord-Holland
Study officials:
affiliation: Association of Dutch Burn Centres (ADBC)
name: Esther Middelkoop, Professor
role: STUDY_DIRECTOR
References: