Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing

NCT07075159 | Recruiting FDA Device

• 1 other identifier: 99942
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the use of a hydrocolloid dressing (DuoDERM EXTRA THIN) as an alternative to the current standard of care. The dressing would be applied immediately after surgery and removed at a post-operative week 1 appointment. The dressing would eliminate the need for antibiotic ointment application and reduce the burden of post-operative care on the patient.

Conditions

Wound Healing; Mohs Micrographic Surgery; Oculofacial Reconstruction

Outcome Measures

Primary Outcomes (1)

• Number of participants with wound dehiscence

  YES/NO type question if wound dehiscence is present after removal of the patch

  3 months

Secondary Outcomes (1)

• Patient and Observer Scar Assessment Scale

  3 months

Study Arms (2)

Wound Dressing

EXPERIMENTAL

At the conclusion of the surgical procedure, patients will receive topical wound dressing to surgical sutured periocular wounds

Device: Hydrocolloid Wound Dressing

Antibiotic Ointment (Control)

NO INTERVENTION

At the conclusion of the surgical procedure, patients will receive topical antibiotic ophthalmic ointment to surgical sutured periocular wounds

Interventions

Hydrocolloid Wound Dressing DEVICE

one time hydrocolloid dressing application

Also known as: DuoDERM Extra Thin dressing

Wound Dressing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years of age
• follow-up at specified intervals (1 week/6 week/3 months) in an office setting
• can give informed consent
• no patients will be excluded on the basis of gender, ethnicity, or religious background

You may not qualify if:

• Patients \<18 years of age or \>100
• allergy to pectin, gelatin, and sodium carboxymethylcellulose
• adults with impaired consent capacity
• incarcerated individuals.

Sponsors & Collaborators

• Janice Hernandez, MD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

RECRUITING

Study Officials

• Janice Hernandez, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connie Dampier

CONTACT

859-562-0750; dampier@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 20, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)