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NCT Number: NCT07233200

Dermabrasion for Free Flap Aesthetic Enhancement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dermabrasion

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caia Hypatia

CONTACT

[email protected]

7175310003 ext. 28-7291

Jessyka G. Lighthall, MD

CONTACT

[email protected]

7175318945

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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