Post Excision/Mohs Scar Laser Resurfacing

Mount Sinai Health System

Status: Completed

Conditions: Skin Cancer

Treatments: Device: Laser Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02130297

GCO 14-0387

Details and patient eligibility

About

The purpose of this study is to evaluate the potential benefits of treating a surgical scar post excision with an ablative fractionated CO2 laser with the goal of decreasing the appearance and size of the scar.

Full description

The objective of this research is to determine, through a split scar study, that treating a post excision scar with a fractionated ablative CO2 laser improves both the texture and cosmetic appearance of the scar. An attempt will be made to determine the ideal timing for treating the excision scar as previous studies have ranged from treating the day of the excision up till 10 weeks post-excision. In order to evaluate the treated portion versus untreated portion of the scar, investigators and the subjects will use a quartile rating scale. In addition, punch biopsy samples will be taken to quantify the difference in collagen architecture 9 weeks after treatment with the laser.

There will be a total of 7 study visits to include the day of the excision and laser treatment if randomized to this group, post-op day number 14 for suture removal as well as laser therapy if the subject has been randomized to that treatment group, 4 weeks post-op, 9 weeks post-op and laser treatment for subjects randomized to this time frame for treatment, 12 weeks post-op, 17 weeks post-op and 24 weeks post-op. Each visit will last approximately 30-45 minutes each in which clinical photos of the surgical scar will be taken and any wound care or side effects of the laser therapy or surgery will be addressed. Healing and scar appearance will be reviewed and rated at each of the six postsurgical visits.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must understand and voluntarily sign an informed consent form.
• Must be male or female and aged >18 years at the time of consent.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• Patients undergoing skin excisions of the face/trunk/extremities.

Exclusion criteria

• Inability to provide voluntary informed consent
• Use of laser or light based treatments to affected areas in past year
• Fitzpatrick Skin types 3-5
• Surgical lesions located on the central chest
• History of keloid formation
• History of Accutane in the last six months

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group 1 - day 1

Active Comparator group

Description:

Group 1 will receive laser therapy to half of the scar the day of the excision.

Treatment:

Device: Laser Treatment

Group 2 - day 14

Active Comparator group

Description:

Group 2 will receive laser therapy at the time of suture removal or post-operative day 14.

Treatment:

Device: Laser Treatment

Group 3 - week 9

Active Comparator group

Description:

Group 3 will receive laser treatment to half the scar at the 9 week postop visit.

Treatment:

Device: Laser Treatment