Dermabrasion for Free Flap Aesthetic Enhancement | NCT07233200

Studies
Dermabrasion for Free Flap Aesthetic Enhancement

NCT07233200

Sponsor

Milton S. Hershey Medical Center

Status

Not yet recruiting

Last Update Posted

Nov 18, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Scar Conditions and Fibrosis of Skin

Interventions

Dermabrasion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Nov 14, 2025

First Posted Date

Nov 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 18, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Split scar	Experimental	Free flap scars will be split and half treated, half untreated for comparison	Device: Dermabrasion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermabrasion	Device	This is the only intervention. Free flap scars will be split and half treated, half untreated then outcomes graded.	Split scar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Jessyka G. Lighthall, MD	Contact	7175318945		jlighthall@pennstatehealth.psu.edu
Caia Hypatia	Contact	7175310003	28-7291	chypatia@pennstatehealth.psu.edu

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D062109	Dermatologic Surgical Procedures
D019651	Plastic Surgery Procedures