Dermal Substitute and Topical Negative Pressure in Burns

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00548314

Acronym

VAC-M

Enrollment

Registered

2007-10-23

Start date

2007-10-31

Completion date

2011-02-28

Last updated

2011-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

Matriderm, Dermal matrix, VAC therapy, Split skin graft, Burns, Scar quality

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.

Interventions

OTHERdermal matrix

1mm thickness matrix composed of collagen-elastin hydrolosate

PROCEDURESplit skin graft

DEVICEVAC therapy (KCI)

VAC therapy for 3-5 days 125mmHg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
skin elasticity parameters (representing scar quality)	after 3 months

Secondary

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026