- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233200
Dermabrasion for Free Flap Aesthetic Enhancement
November 14, 2025 updated by: Jessyka Lighthall, Milton S. Hershey Medical Center
Serial Dermabrasion for Aesthetic Enhancement of Free Flap Skin Paddles and Donor Sites: A Prospective Split-Flap/Scar Controlled Study
The purpose of this study is to evaluate the aesthetic benefit and safety of serial dermabrasion for free flap skin paddles and donor site scars in head and neck reconstruction.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
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
- Name: Jessyka G. Lighthall, MD
- Phone Number: 7175318945
- Email: jlighthall@pennstatehealth.psu.edu
Study Contact Backup
- Name: Caia Hypatia
- Phone Number: 28-7291 7175310003
- Email: chypatia@pennstatehealth.psu.edu
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:
- Adults aged 18 years or older.
- History of successful free flap reconstruction with a cutaneous skin paddle in the head and neck region.
- Patients with benign (eg. osteoradionecrosis, trauma) or malignant (eg. squamous cell carcinoma) diagnoses requiring free flap reconstruction.
- Benign free flap patients must be a minimum 3 months post-operative to ensure flap maturity. Malignant free flap patients must be a minimum of 3 months post-operative or post-radiation with no further cancer treatment (eg. radiation, surgery, chemotherapy) planned at that time.
- Flap skin paddle must be of sufficient size and external to allow for split-treatment design (minimum 4 cm in diameter). Donor site scar must also be sufficient size (minimum 6 cm in length)
- Patients must have ability to provide informed consent.
- Willingness and ability to comply with the treatment and follow-up schedule.
Exclusion Criteria:
- Inability to give informed consent.
- Evidence of active flap or radiation skin complications (e.g., infection, partial necrosis, wound breakdown).
- Completion of head and neck radiation therapy within 3 months of first dermabrasion treatment date.
- Uncontrolled diabetes mellitus (HbA1c > 8.0%).
- Current antibiotic use or known immunocompromised state.
- History of keloid formation or hypertrophic scarring.
- Fitzpatrick skin type VI or higher (due to increased risk of pigmentary changes).
- Use of isotretinoin medication within the past 3 month (known to induce photosensitivity).
- Current use of blood thinners that cannot be safely paused.
- Known photosensitivity disorders.
- Active malignancy requiring ongoing treatment.
- Inability or unwillingness to avoid sun exposure during the treatment period.
- Inability to perform or adhere to prescribed wound care.
- Inability or unwillingness to attend follow-up visits.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Split scar
Free flap scars will be split and half treated, half untreated for comparison
|
This is the only intervention.
Free flap scars will be split and half treated, half untreated then outcomes graded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aesthetic grading of treated area compared to untreated
Time Frame: 1, 3, and 6 months post-treatment
|
Aesthetic improvement of the treated half of the free flap skin paddle/donor site scar, as compared to the untreated half.
This will be measured through blinded evaluations of standardized clinical photographs.
Each side of the skin paddle or donor site scar will be labeled as side 1 or 2.
|
1, 3, and 6 months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jessyka G Lighthall, Milton S. Hershey Medical Center
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 (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 18, 2025
Study Record Updates
Last Update Posted (Actual)
November 18, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00027645
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.
No
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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