Dermabrasion for Free Flap Aesthetic Enhancement

Penn State Health

Status: Begins enrollment in 4 months

Conditions: Scar Conditions and Fibrosis of Skin

Treatments: Device: Dermabrasion

Study type: Interventional

Funder types: Other

Identifiers

NCT07233200

00027645

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Split scar

Experimental group

Description:

Free flap scars will be split and half treated, half untreated for comparison

Treatment:

Device: Dermabrasion