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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00609908
• Other study ID #: 06.201
• Secondary ID: 06.201
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2008
• Last updated: June 25, 2015
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2015
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Scars

Intervention

Procedure:
• Split skin graft
After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)
• skin stretching device
after woundbed preparation the wound is primarily closed by aid of the skin stretching device
• serial excision
as much scar as possible is excised, whereafter the wound is closed
• skin stretching device
after the scar is excised, the wound is primarily closed by aid of the skin stretching device

Locations

Country	Name	City	State
Netherlands	Red Cross Hospital	Beverwijk

Sponsors (1)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the surface area of the scar after 12 months		3 and 12 months after surgery	No
Secondary	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	No