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Dermabrasion for Free Flap Aesthetic Enhancement

Serial Dermabrasion for Aesthetic Enhancement of Free Flap Skin Paddles and Donor Sites: A Prospective Split-Flap/Scar Controlled Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07233200
Enrollment
40
Registered
2025-11-18
Start date
2026-07-01
Completion date
2028-01-31
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar Conditions and Fibrosis of Skin

Keywords

scar, head and neck reconstruction, dermabrasion, aesthetics

Brief 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.

Interventions

This is the only intervention. Free flap scars will be split and half treated, half untreated then outcomes graded.

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults aged 18 years or older. 2. History of successful free flap reconstruction with a cutaneous skin paddle in the head and neck region. 3. Patients with benign (eg. osteoradionecrosis, trauma) or malignant (eg. squamous cell carcinoma) diagnoses requiring free flap reconstruction. 4. 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. 5. 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) 6. Patients must have ability to provide informed consent. 7. Willingness and ability to comply with the treatment and follow-up schedule.

Exclusion criteria

1. Inability to give informed consent. 2. Evidence of active flap or radiation skin complications (e.g., infection, partial necrosis, wound breakdown). 3. Completion of head and neck radiation therapy within 3 months of first dermabrasion treatment date. 4. Uncontrolled diabetes mellitus (HbA1c \> 8.0%). 5. Current antibiotic use or known immunocompromised state. 6. History of keloid formation or hypertrophic scarring. 7. Fitzpatrick skin type VI or higher (due to increased risk of pigmentary changes). 8. Use of isotretinoin medication within the past 3 month (known to induce photosensitivity). 9. Current use of blood thinners that cannot be safely paused. 10. Known photosensitivity disorders. 11. Active malignancy requiring ongoing treatment. 12. Inability or unwillingness to avoid sun exposure during the treatment period. 13. Inability to perform or adhere to prescribed wound care. 14. Inability or unwillingness to attend follow-up visits.

Design outcomes

Primary

MeasureTime frameDescription
Aesthetic grading of treated area compared to untreated1, 3, and 6 months post-treatmentAesthetic 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.

Contacts

Primary ContactJessyka G. Lighthall, MD
jlighthall@pennstatehealth.psu.edu7175318945
Backup ContactCaia Hypatia
chypatia@pennstatehealth.psu.edu7175310003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026