Wound HealingHCD Wound HealNCT07075159
Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing
A study testing Hydrocolloid Wound Dressing in people with Wound Healing and Mohs Micrographic Surgery, run by Janice Hernandez, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Wound Healing, Mohs Micrographic Surgery, Oculofacial Reconstruction
- What is being tested?
- Hydrocolloid Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients <18 years of age or >100
- allergy to pectin, gelatin, and sodium carboxymethylcellulose
- adults with impaired consent capacity
- incarcerated individuals.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Hydrocolloid Wound Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocolloid Wound DressingDevice
Also called DuoDERM Extra Thin dressing
one time hydrocolloid dressing application
| Study group | Role | What they receive |
|---|---|---|
| Wound Dressing | Experimental | At the conclusion of the surgical procedure, patients will receive topical wound dressing to surgical sutured periocular wounds Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Wound Dehiscence
YES/NO type question if wound dehiscence is present after removal of the patch
Measured: 3 months
Secondary outcomes (1)
Number of Participants Assessed Using the Patient and Observer Scar Assessment Scale
Number of participants who completed the Patient and Observer Scar Assessment Scale following surgery. The assessment was performed at the 3 month postoperative visit to evaluate scar appearance filled out by both patient and provider. 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start28 Feb 2025
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janice Hernandez, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janice Hernandez, MD, University of Kentucky
- Investigators
- Janice Hernandez, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075159
- Sponsor's protocol ID
- 99942
- Acronym
- HCD Wound Heal
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing
- ClinicalTrials.gov ID
- NCT07075159
- Acronym / sponsor ID
- HCD Wound Heal / 99942
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Janice Hernandez, MDUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound Dressing | Experimental | Device: Hydrocolloid Wound DressingAt the conclusion of the surgical procedure, patients will receive topical wound dressing to surgical sutured periocular wounds |
| Antibiotic Ointment (Control) | No intervention | –At the conclusion of the surgical procedure, patients will receive topical antibiotic ophthalmic ointment to surgical sutured periocular wounds |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients <18 years of age or >100
- allergy to pectin, gelatin, and sodium carboxymethylcellulose
- adults with impaired consent capacity
- incarcerated individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocolloid Wound DressingAlso: DuoDERM Extra Thin dressingone time hydrocolloid dressing application | Device | Wound Dressing |
Primary outcome
Number of Participants With Wound Dehiscence
Time frame: 3 months
YES/NO type question if wound dehiscence is present after removal of the patch
1 secondary outcome
Number of Participants Assessed Using the Patient and Observer Scar Assessment Scale
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Hernandez, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocolloid Wound Dressing in people with Wound Healing and Mohs Micrographic Surgery, run by Janice Hernandez, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Wound Dehiscence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.