Scar Conditions and Fibrosis of SkinNCT07233200
Dermabrasion for Free Flap Aesthetic Enhancement
A study testing Dermabrasion in people with Scar Conditions and Fibrosis of Skin, run by Milton S. Hershey Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar Conditions and Fibrosis of Skin
- What is being tested?
- Dermabrasion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Scar Conditions and Fibrosis of Skin
- Being tested
- Dermabrasion
- Keywords
- scar, head and neck reconstruction, dermabrasion, aesthetics
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermabrasionDevice
This is the only intervention. Free flap scars will be split and half treated, half untreated then outcomes graded.
| Study group | Role | What they receive |
|---|---|---|
| Split scar | Experimental | Free flap scars will be split and half treated, half untreated for comparison Receives: Device: Dermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic grading of treated area compared to untreated
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.
Measured: 1, 3, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar Conditions and Fibrosis of SkinStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessyka Lighthall, Milton S. Hershey Medical Center
- Investigators
- Jessyka G Lighthall, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233200
- Sponsor's protocol ID
- 00027645
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Dermabrasion for Aesthetic Enhancement of Free Flap Skin Paddles and Donor Sites: A Prospective Split-Flap/Scar Controlled Study
- ClinicalTrials.gov ID
- NCT07233200
- Acronym / sponsor ID
- 00027645
- Conditions
- Scar Conditions and Fibrosis of Skin
- Keywords
- scar, head and neck reconstruction, dermabrasion, aesthetics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Split scar | Experimental | Device: DermabrasionFree flap scars will be split and half treated, half untreated for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| DermabrasionThis is the only intervention. Free flap scars will be split and half treated, half untreated then outcomes graded. | Device | Split scar |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- 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.
Jessyka G Lighthall principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Dermabrasion in people with Scar Conditions and Fibrosis of Skin, run by Milton S. Hershey Medical Center.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessyka G. Lighthall, MD (7175318945, jlighthall@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aesthetic grading of treated area compared to untreated (time frame: 1, 3, and 6 months post-treatment). 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 24 Aug 2026.