The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1) inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.
This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. The study will be performed on patients undergoing an excision at Bispebjerg Dermatological Department. One randomly allocated part of each included wound will receive three NAFL-treatments and the other part will serve as untreated control wound. Scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation
Clincial evaluation on Patient observer scar assessement scale (POSAS)
validated scar scale
Time frame: 3 months followup
Photoevaluation on visual analogue scale
3 independent dermatologists will evaluate on VAS
Time frame: 3 months follow-up
Reflectance measurement
measurement of erythema and pigment
Time frame: 3 months followup
Clinical evaluation on Vancouver Scar Scale
validated scar scale
Time frame: 3 months followup
Clincial evaluation on Patient observer scar assessement scale (POSAS)
validated scar scale
Time frame: 1month follow-up
Clinical evaluation on Vancouver Scar Scale
validated scar scale
Time frame: 1month follow-up and
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