The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction - Full Text View

Purpose

Objective:

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

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;
scar reconstructions: wound closure by means of skin stretching during one operative procedure should lead to a comparable scar surface in comparison to the mutiple 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;
vascularisation and pigmentation;
thickness;
dermal architecture.

After 12 months adults will undergo a biopsy of the scar under local anaesthesia. 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 randomisation if skin stretching or split skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be performed.

Condition	Intervention	Phase
Burns Scars	Procedure: Split skin graft Procedure: skin stretching device Procedure: serial excision	Phase III

MedlinePlus related topics:

Burns Scars

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

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

Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:

the surface area of the scar after 12 months [ Time Frame: 3 and 12 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularisation & pigmentation (DermaSpectrometer); - scar thickness [ Time Frame: 3 and 12 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator Acute Burn Wounds: Split Skin Graft	Procedure: Split skin graft After woundbed preparation the skin defect is covered with a skin transplant (split skin graft)
A2: Experimental Acute burns wounds: 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
B1: Active Comparator Scar reconstruction: serial excision	Procedure: serial excision as much scar as possible is excised, whereafter the wound is closed
B2: Experimental Scar reconstruction: primary closure, using skin stretching device	Procedure: skin stretching device after the scar is excised, the wound is primarily closed by aid of the skin stretching device

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:

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. automutulation);
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);

Primary study parameters/outcome of the study:

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

Secundary 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

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:

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. automutulation);
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609908

Contacts


Contact: P.D.H.M. Verhaegen, MD	0031251265459	pverhaegen@rkz.nl

Contact: P.P.M. van Zuijlen

Locations


Netherlands
	Red Cross Hospital	Recruiting
	Beverwijk, Netherlands
	Contact: P.D.H.M. Verhaegen, MD 0031251265459 pverhaegen@rkz.nl

Sponsors and Collaborators

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

More Information

Responsible Party:	Association of Dutch Burn Centres ( Association of Dutch Burn Centres )
Study ID Numbers:	06.201, 06.201
First Received:	January 25, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00609908
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Study placed in the following topic categories:

Burns

Skin Diseases

Wounds and Injuries

Disorders of Environmental Origin

Cicatrix

ClinicalTrials.gov processed this record on November 03, 2008

Sponsored by:	Association of Dutch Burn Centres
Information provided by:	Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:	NCT00609908