Dermabrasion for Free Flap Aesthetic Enhancement

NCT07233200 | Not Yet Recruiting FDA Device

• 1 other identifier: 00027645
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scar Conditions and Fibrosis of Skin

Keywords

scar; head and neck reconstruction; dermabrasion; aesthetics

Outcome Measures

Primary Outcomes (1)

• 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.

  1, 3, and 6 months post-treatment

Study Arms (1)

Split scar

EXPERIMENTAL

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

Device: Dermabrasion

Interventions

Dermabrasion DEVICE

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

Split scar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Cicatrix

Interventions

Dermabrasion

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Jessyka G Lighthall

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessyka G. Lighthall, MD

CONTACT

7175318945; jlighthall@pennstatehealth.psu.edu

Caia Hypatia

CONTACT

7175310003; chypatia@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Facial Plastic and Reconstructive Surgery, Professor, Department of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share