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

NCT ID: NCT00609908

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-06-30

Brief 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.

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.

Conditions

Burns; Scars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A1

Acute Burn Wounds: Wound debridement and split skin grafting

Group Type: ACTIVE_COMPARATOR

Split skin graft

Intervention Type: PROCEDURE

After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)

A2

Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device

Group Type: EXPERIMENTAL

skin stretching device

Intervention Type: PROCEDURE

after woundbed preparation the wound is primarily closed by aid of the skin stretching device

B1

Scar reconstruction: serial excision

Group Type: ACTIVE_COMPARATOR

serial excision

Intervention Type: PROCEDURE

as much scar as possible is excised, whereafter the wound is closed

B2

Scar reconstruction: primary closure, using skin stretching device

Group Type: EXPERIMENTAL

skin stretching device

Intervention Type: PROCEDURE

after the scar is excised, the wound is primarily closed by aid of the skin stretching device

Interventions

Split skin graft

After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)

Intervention Type: PROCEDURE

skin stretching device

after woundbed preparation the wound is primarily closed by aid of the skin stretching device

Intervention Type: PROCEDURE

serial excision

as much scar as possible is excised, whereafter the wound is closed

Intervention Type: PROCEDURE

skin stretching device

after the scar is excised, the wound is primarily closed by aid of the skin stretching device

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Association of Dutch Burn Centres

OTHER

Sponsor Role: lead

Responsible Party

Association of Dutch Burn Centres

Principal Investigators

E Middelkoop, Professor

Role: PRINCIPAL_INVESTIGATOR

VU MC

P.P.M. van Zuijlen, MD, PhD

Role: STUDY_DIRECTOR

Red Cross Hospital Beverwijk

Locations

Red Cross Hospital

Beverwijk, , Netherlands

Countries

Netherlands

Other Identifiers

06.201

Identifier Type: -

Identifier Source: secondary_id

06.201

Identifier Type: -

Identifier Source: org_study_id