Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing (HCD Wound Heal)

December 15, 2025 updated by: Janice Hernandez, MD
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • University of Kentucky
        • Principal Investigator:
          • Janice Hernandez, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wound Dressing
At the conclusion of the surgical procedure, patients will receive topical wound dressing to surgical sutured periocular wounds
Device: Hydrocolloid Wound Dressing
one time hydrocolloid dressing application
Other Names:
  • DuoDERM Extra Thin dressing
No Intervention: Antibiotic Ointment (Control)
At the conclusion of the surgical procedure, patients will receive topical antibiotic ophthalmic ointment to surgical sutured periocular wounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with wound dehiscence
Time Frame: 3 months
YES/NO type question if wound dehiscence is present after removal of the patch
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale
Time Frame: 3 months
Patient and Observer Scar Assessment Scale filled out by both patient and provider at postoperative visit of both HCD Dressing and ointment. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janice Hernandez, MD

Investigators

  • Principal Investigator: Janice Hernandez, MD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 23, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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