The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction

Summary

Objective:

A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories:

1. acute burn wounds: wound closure by means of skin stretching should lead to a significant reduction of scar surface area in comparison to the standard technique, the split skin grafting;
2. scar reconstructions: wound closure by means of skin stretching during one operative procedure should lead to a comparable scar surface in comparison to the multiple procedures techniques such as serial excision.

Study design:

Skin stretching will be compared to split skin grafting and should result in burn wound closure with significantly smaller scars. Also, a comparison will be made between the technique of serial excision versus skin stretching for scar reconstructions.

Scar evaluation three and twelve months after surgery will include the following parameters:

* surface area;
* Patient and Observer Scar Assessment Scale (POSAS);
* elasticity;
* vascularization and pigmentation;
* thickness;
* dermal architecture.

After 12 months adults will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the skin stretcher will undergo one extra biopsy of the formerly stretched skin.

Intervention:

At the start of the operation will be determined by randomization if skin stretching or split skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be performed.

Conditions

• Burns
• Scars

Interventions

PROCEDURE

Split skin graft

After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)

PROCEDURE

skin stretching device

after woundbed preparation the wound is primarily closed by aid of the skin stretching device

PROCEDURE

serial excision

as much scar as possible is excised, whereafter the wound is closed

PROCEDURE

skin stretching device

after the scar is excised, the wound is primarily closed by aid of the skin stretching device

Sponsors & Collaborators

• Association of Dutch Burn Centres

  lead OTHER

Principal Investigators

• E Middelkoop, Professor · VU MC

• P.P.M. van Zuijlen, MD, PhD · Red Cross Hospital Beverwijk

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• Netherlands

Study Locations