Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects

NCT05074238 | Active Not Recruiting

• 1 other identifier: 1784449
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the potential influence of sun protection on the aesthetic outcome of post-surgical scars following the reconstruction of Mohs micrographic surgery defects via linear repair. This study will be performed as a randomized split-wound study. Half of the wound will be treated with zinc containing sunscreen and the other half of the wound would not be treated. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as a colorimeter to measure the amount of vascularity, and hyperpigmentation between the treated and the non-treated area compared to the 'surrounding skin' defined as skin in the proximity but not adjacent to the wound. Any adverse events will also be recorded.

Conditions

Surgical Wound; Wound Heal; Wound of Skin; Scar

Keywords

Sun Protection; Cutaneous Surgery; Wound Closure

Outcome Measures

Primary Outcomes (1)

• Patient observer assessment score (POSAS)

  The primary end point will be the two blinded reviewers sum of the component parts of the patient observer assessment score (POSAS). The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.

  3-12 months

Secondary Outcomes (1)

• Colorimeter measurement of wound vascularity and hyperpigmentation.

  3-12 months

Study Arms (2)

Sunscreen Application

EXPERIMENTAL

The study participant will be instructed to start applying the sunscreen provided to them to the randomly assigned half of the wound (A or B).

Other: Zinc containing suncreen

No Suncreen Application

EXPERIMENTAL

The study participant will be instructed to not apply the sunscreen provided to them to the randomly assigned half of the wound (A or B).

Other: Zinc containing suncreen

Interventions

Zinc containing suncreen OTHER

The study participant will be randomized via a randomization tool within the REDCap database as to which half of the wound ("A" or "B") the patient will be asked to apply zinc containing sunscreen for the duration of the study.

No Suncreen Application; Sunscreen Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Patient is able to provide informed consent
• Patient is scheduled for a cutaneous excisional surgical procedure
• Cutaneous surgical wound closed via linear repair
• Surgery performed on sunlight-exposed anatomical regions (head, face, neck, hairless scalp)
• Patient is willing to return for follow-up visit to clinic

You may not qualify if:

• Patient is incarcerated
• Patient is \< 18 years of age
• Patient is pregnant
• Patient unwilling to return for 3-month follow-up
• History of reaction to zinc containing sunscreen
• History of collagen vascular disease

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Surgical Wound; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Factorial Assignment At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: July 16, 2021
• Primary Completion: December 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)