The technique of skin stretching for acute burn treatment and scar reconstruction: Clinical applications and working mechanisms.

Phase 4

Recruiting

Conditions: burn wounds
scars
10014982
10040795

Registration Number: NL-OMON31463

Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Acute Burn wounds or scar reconstructions that require surgical treatment;
2. The defect is too large for direct closure by advancement of the adjacent skin in one operation by standard techniques;
3. Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure.

Exclusion Criteria

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. automutulation);
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);
9. scars requiring reconstructive surgery that are not suitable for serial excision
10. wounds that can be closed by excision and primary closure (both categories) or by a local flap such as Z-plasty (scar reconstruction category);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the surface area of the scar after 12 months<br /><br>(measured with a validated objective photographic device)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>All scars will also be subjected to the scar evaluation protocol after 3 and 12<br /><br>months by an independent observer for the evaluation of the:<br /><br>- patient and observer scar assessment scale (POSAS);<br /><br>- scar elasticity (Cutometer);<br /><br>- scar vascularisation & pigmentation (DermaSpectrometer);<br /><br>- scar thickness (histopathology, only after 12 months).<br /><br>Patients will also complete the patients part of the POSAS.<br /><br>Punch biopsies are taken for morphometry of dermal architecture (Fourier<br /><br>analysis). During surgery one biopsy is obtained of the normal skin. In the<br /><br>experimental group an additional biopsy is obtained at the end of the<br /><br>stretching procedure in order to be able to compare structure of the dermal<br /><br>matrix and orientation of the collagen fibers. After 1 year, in adults, one<br /><br>biopsy is taken from the scar. The experimental group will undergo one<br /><br>additional biopsy of the formerly stretched skin.</p><br>