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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Association of Dutch Burn Centres.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:
NCT00609908
First received: January 25, 2008
Last updated: June 17, 2010
Last verified: June 2010

January 25, 2008
June 17, 2010
December 2007
June 2011   (final data collection date for primary outcome measure)
the surface area of the scar after 12 months [ Time Frame: 3 and 12 months after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00609908 on ClinicalTrials.gov Archive Site
scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness [ Time Frame: 3 and 12 months after surgery ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Burns
  • Scars
  • 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
  • Active Comparator: A1
    Acute Burn Wounds: Wound debridement and split skin grafting
    Intervention: Procedure: Split skin graft
  • Experimental: A2
    Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device
    Intervention: Procedure: skin stretching device
  • Active Comparator: B1
    Scar reconstruction: serial excision
    Intervention: Procedure: serial excision
  • Experimental: B2
    Scar reconstruction: primary closure, using skin stretching device
    Intervention: Procedure: skin stretching device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2011
June 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00609908
06.201, 06.201
No
Association of Dutch Burn Centres
Association of Dutch Burn Centres
Not Provided
Principal Investigator: E Middelkoop, Professor VU MC
Study Director: P.P.M. van Zuijlen, MD, PhD Red Cross Hospital Beverwijk
Association of Dutch Burn Centres
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP