Dermal Substitute and Topical Negative Pressure in Burns (VAC-M)

Association of Dutch Burn Centres

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Procedure: Split skin graft; Device: VAC therapy (KCI); Other: dermal matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT00548314

07.109

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 4 patient groups

1

Experimental group

Description:

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.

Treatment:

Other: dermal matrix

Device: VAC therapy (KCI)

2

Experimental group

Description:

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.

Treatment:

Other: dermal matrix

3

Experimental group

Description:

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.

Treatment:

Device: VAC therapy (KCI)

4

Active Comparator group

Description:

After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5.

Treatment:

Procedure: Split skin graft