Scar Improvement by Laser
Conditions
Keywords
scar NAFL laser
Brief summary
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
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.
Interventions
RADIATIONNAFL-treatment
non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the outcome assessor will not know which side is the treated side of scar
Intervention model description
split scar study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clincial evaluation on Patient observer scar assessement scale (POSAS) | 3 months followup | validated scar scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photoevaluation on visual analogue scale | 3 months follow-up | 3 independent dermatologists will evaluate on VAS |
| Reflectance measurement | 3 months followup | measurement of erythema and pigment |
| Clinical evaluation on Vancouver Scar Scale | 3 months followup | validated scar scale |
| Clincial evaluation on Patient observer scar assessement scale (POSAS) | 1month follow-up | validated scar scale |
Outcome results
None listed