Recruiting
HCD Wound Heal

Hydrocolloid Dressings for Oculofacial Wound Healing

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What is being tested

Hydrocolloid Wound Dressing

Device
Who is being recruted

Wound Healing

+ Mohs Micrographic Surgery
+ Oculofacial Reconstruction
From 18 to 100 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2025

See protocol details

Summary

Principal SponsorJanice Hernandez, MD
Study ContactConnie Dampier
Last updated: September 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 28, 2025Actual date on which the first participant was enrolled.

This clinical trial is investigating if a special type of dressing called a hydrocolloid dressing, specifically DuoDERM EXTRA THIN, can be a better option for patients undergoing oculofacial plastic and reconstructive surgery. These surgeries involve the area around the eyes and face, which can be sensitive and require careful healing. Normally, after such surgeries, patients need to apply antibiotic ointment, which can be time-consuming and inconvenient. This study seeks to find out if using this dressing can replace the ointment and simplify post-operative care, making recovery easier for patients. In this study, participants will have the hydrocolloid dressing applied immediately after their surgery. The dressing will stay in place until their follow-up appointment one week later, at which point it will be removed. Researchers will evaluate how well the dressing works in terms of healing and whether it effectively reduces the need for additional care like applying ointments. This approach aims to lessen the burden of post-surgery care and improve overall patient experience by potentially offering a simpler and effective wound care solution.

Official TitleHydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing 
Principal SponsorJanice Hernandez, MD
Study ContactConnie Dampier
Last updated: September 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Wound Healing
Mohs Micrographic Surgery
Oculofacial Reconstruction
Criteria
4 inclusion criteria required to participate
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
4 exclusion criteria prevent from participating
Patients <18 years of age or >100
allergy to pectin, gelatin, and sodium carboxymethylcellulose
adults with impaired consent capacity
incarcerated individuals

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
At the conclusion of the surgical procedure, patients will receive topical wound dressing to surgical sutured periocular wounds
Group II
No Intervention
At the conclusion of the surgical procedure, patients will receive topical antibiotic ophthalmic ointment to surgical sutured periocular wounds
Study Objectives
Primary Objectives

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

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
University of KentuckyLexington, United StatesSee the location
Recruiting
One Study Center