Dermabrasion for Free Flap Aesthetic Enhancement

NCT ID: NCT07233200

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-01
• Study Completion Date: 2028-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Split scar

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

Group Type: EXPERIMENTAL

Dermabrasion

Intervention Type: DEVICE

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

Interventions

Dermabrasion

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jessyka Lighthall

Chief, Facial Plastic and Reconstructive Surgery, Professor, Department of Otolaryngology-Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessyka G Lighthall

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Central Contacts

Jessyka G. Lighthall, MD

Role: CONTACT

jlighthall@pennstatehealth.psu.edu

7175318945

Caia Hypatia

Role: CONTACT

chypatia@pennstatehealth.psu.edu

7175310003 ext. 28-7291

Other Identifiers

00027645

Identifier Type: -

Identifier Source: org_study_id