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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
  Purpose

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.


Condition Intervention Phase
Burns
Scars
Procedure: Split skin graft
Procedure: skin stretching device
Procedure: serial excision
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction: Clinical Applications and Working Mechanisms.

Resource links provided by NLM:


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 vascularization & 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: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Red Cross Hospital
Beverwijk, Netherlands
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

No publications provided

Responsible Party: Association of Dutch Burn Centres
ClinicalTrials.gov Identifier: NCT00609908     History of Changes
Other Study ID Numbers: 06.201, 06.201
Study First Received: January 25, 2008
Last Updated: June 17, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014