Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling

Conditions
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Scar Improvement by Laser

Intervention / Treatment
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* Radiation: NAFL-treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: o Subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (NMSC) lesions. The length of postoperative wound should be estimated to minimum 2.5 cm and may be located on any region of the body Minimum 18 years old Presenting full medical record report at study initiation Fitzpatrick skin type I-III Non-smokers Written informed consent obtained from subject Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation Exclusion Criteria: o History of or presenting with a keloid scar A subject with a systemic disease not yet stabilized If the patient is pregnant Visible recent sun exposure in test area Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study Current use of topical treatment and lack of willingness to refrain from future use of topical treatment, such as i.e. silicone products, that potentially can interfere with the test results Unable to follow the outlined study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split scar study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAFL-treated wounds<br>NAFL treated wounds | Radiation: NAFL-treatment<br>* non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation<br>|
| No Intervention: Control<br>untreated control wound | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clincial evaluation on Patient observer scar assessement scale (POSAS) | validated scar scale | 3 months followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photoevaluation on visual analogue scale | 3 independent dermatologists will evaluate on VAS | 3 months follow-up | 
| Reflectance measurement | measurement of erythema and pigment | 3 months followup | 
| Clinical evaluation on Vancouver Scar Scale | validated scar scale | 3 months followup | 
| Clincial evaluation on Patient observer scar assessement scale (POSAS) | validated scar scale | 1month follow-up | 
| Clinical evaluation on Vancouver Scar Scale | validated scar scale | 1month follow-up and | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar NAFL laser