Dermal Substitute and Topical Negative Pressure in Burns

Study Overview
=================
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.

Official Title
-----------------
Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: dermal matrix
* Procedure: Split skin graft
* Device: VAC therapy (KCI)


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. | Other: dermal matrix<br>* 1mm thickness matrix composed of collagen-elastin hydrolosate<br>* Other names: Matriderm;Device: VAC therapy (KCI)<br>* VAC therapy for 3-5 days 125mmHg<br>|
| Experimental: 2<br>After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5. | Other: dermal matrix<br>* 1mm thickness matrix composed of collagen-elastin hydrolosate<br>* Other names: Matriderm;|
| Experimental: 3<br>After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days. | Device: VAC therapy (KCI)<br>* VAC therapy for 3-5 days 125mmHg<br>|
| Active Comparator: 4<br>After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5. | Procedure: Split skin graft<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin elasticity parameters (representing scar quality) |  | after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer) |  | after 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Matriderm, Dermal matrix, VAC therapy, Split skin graft, Scar quality