The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction
Primary Purpose
Burns, Scars
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Split skin graft
skin stretching device
serial excision
skin stretching device
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility 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).
Sites / Locations
- Red Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
A1
A2
B1
B2
Arm Description
Acute Burn Wounds: Wound debridement and split skin grafting
Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device
Scar reconstruction: serial excision
Scar reconstruction: primary closure, using skin stretching device
Outcomes
Primary Outcome Measures
the surface area of the scar after 12 months
Secondary Outcome Measures
scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness
Full Information
NCT ID
NCT00609908
First Posted
January 25, 2008
Last Updated
June 25, 2015
Sponsor
Association of Dutch Burn Centres
1. Study Identification
Unique Protocol Identification Number
NCT00609908
Brief Title
The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction
Official Title
The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction: Clinical Applications and Working Mechanisms.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Association of Dutch Burn Centres
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective:
A randomized 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 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.
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. 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);
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Description
Acute Burn Wounds: Wound debridement and split skin grafting
Arm Title
A2
Arm Type
Experimental
Arm Description
Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device
Arm Title
B1
Arm Type
Active Comparator
Arm Description
Scar reconstruction: serial excision
Arm Title
B2
Arm Type
Experimental
Arm Description
Scar reconstruction: primary closure, using skin stretching device
Intervention Type
Procedure
Intervention Name(s)
Split skin graft
Intervention Description
After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)
Intervention Type
Procedure
Intervention Name(s)
skin stretching device
Intervention Description
after woundbed preparation the wound is primarily closed by aid of the skin stretching device
Intervention Type
Procedure
Intervention Name(s)
serial excision
Intervention Description
as much scar as possible is excised, whereafter the wound is closed
Intervention Type
Procedure
Intervention Name(s)
skin stretching device
Intervention Description
after the scar is excised, the wound is primarily closed by aid of the skin stretching device
Primary Outcome Measure Information:
Title
the surface area of the scar after 12 months
Time Frame
3 and 12 months after surgery
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E Middelkoop, Professor
Organizational Affiliation
VU MC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P.P.M. van Zuijlen, MD, PhD
Organizational Affiliation
Red Cross Hospital Beverwijk
Official's Role
Study Director
Facility Information:
Facility Name
Red Cross Hospital
City
Beverwijk
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction
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