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

The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction: Clinical Applications and Working Mechanisms.

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.

Study Overview

• Status: Completed
• Conditions: Burns; Scars
• Intervention / Treatment: Procedure: Split skin graft; Procedure: skin stretching device; Procedure: skin stretching device; Procedure: serial excision

Detailed Description

Eligibility criteria:

Inclusion:

1. Acute Burn wounds or scar reconstructions that require surgical treatment; 2. Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure.

3. Age >= 18 years

Exclusion:

1. language barrier;
2. known history of keloid formation;
3. systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
4. local or systemic application of corticosteroids;
5. psychiatric diseases leading to study bias (e.g. automutilation);
6. skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
7. radiated skin;
8. wound located at extremities, exceeding >33% of circumference (acute burn category);

Primary study parameters/outcome of the study:

The primary study parameter is the surface area of the scar after 12 months

Secondary study parameters/outcome of the study (if applicable):

All scars will also be subjected to the scar evaluation protocol after 3 and 12 months by an independent observer for the evaluation of the:

• patient and observer scar assessment scale (POSAS);
• scar elasticity (Cutometer);
• scar vascularisation & pigmentation (DermaSpectrometer);
• scar thickness (histopathology, only after 12 months).

Punch biopsies are taken for morphometry of dermal architecture (Fourier analysis). During surgery one biopsy is obtained of the normal skin. In the experimental group an additional biopsy is obtained at the end of the stretching procedure in order to be able to compare structure of the dermal matrix and orientation of the collagen fibers.

After 1 year, one biopsy is taken from the scar. The experimental group will undergo one additional biopsy of the formerly stretched skin.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Beverwijk, Netherlands
    • Red Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Acute Burn wounds or scar reconstructions that require surgical treatment;
• Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure;
• Age >= 18 years.

Exclusion criteria:

• Language barrier;
• Known history of keloid formation;
• Systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
• Local or systemic application of corticosteroids;
• Psychiatric diseases leading to study bias (e.g. automutilation);
• Skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
• Radiated skin;
• Wound located at extremities, exceeding >33% of circumference (acute burn category).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1; Acute Burn Wounds: Wound debridement and split skin grafting	Procedure: Split skin graft; After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)
Experimental: A2; Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device	Procedure: skin stretching device; after woundbed preparation the wound is primarily closed by aid of the skin stretching device; Procedure: skin stretching device; after the scar is excised, the wound is primarily closed by aid of the skin stretching device
Active Comparator: B1; Scar reconstruction: serial excision	Procedure: serial excision; as much scar as possible is excised, whereafter the wound is closed
Experimental: B2; Scar reconstruction: primary closure, using skin stretching device	Procedure: skin stretching device; after woundbed preparation the wound is primarily closed by aid of the skin stretching device; Procedure: skin stretching device; after the scar is excised, the wound is primarily closed by aid of the skin stretching device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the surface area of the scar after 12 months	3 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness	3 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Association of Dutch Burn Centres
• Investigators: Principal Investigator: E Middelkoop, Professor, VU MC; Study Director: P.P.M. van Zuijlen, MD, PhD, Red Cross Hospital Beverwijk

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: January 25, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimate): February 7, 2008

Study Record Updates

• Last Update Posted (Estimate): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 06.201