CClinicalTrials.gg
Not yet recruitingNCT07233200Updated Aug 24, 2026

Dermabrasion for Free Flap Aesthetic Enhancement

An interventional study of Dermabrasion in Scar Conditions and Fibrosis of Skin, sponsored by Milton S. Hershey Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Scar Conditions and Fibrosis of Skin

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Keywords

  • scar
  • head and neck reconstruction
  • dermabrasion
  • aesthetics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Split scar

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

    Device: Dermabrasion

Interventions

  • DeviceDermabrasion

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

05

What researchers measure

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.

    Time frame: 1, 3, and 6 months post-treatment

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07233200
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Jessyka Lighthall (Chief, Facial Plastic and Reconstructive Surgery, Professor, Department of Otolaryngology-Head and Neck Surgery, Milton S. Hershey Medical Center) — Principal investigator
First posted
Nov 18, 2025
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Aug 24, 2026

Study contacts

Jessyka G. Lighthall, MD
Contact
jlighthall@pennstatehealth.psu.edu
7175318945
Caia Hypatia
Contact
chypatia@pennstatehealth.psu.edu
7175310003 ext. 28-7291
Jessyka G Lighthall
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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