Dermabrasion for Free Flap Aesthetic Enhancement
ConditionScar Conditions and Fibrosis of Skin
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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%).
Trial design
Design model
Single group
Treatments tested in this trial
Dermabrasion
DeviceThis is the only intervention. Free flap scars will be split and half treated, half untreated then outcomes graded.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Split scarExperimental treatment 1 intervention
Trial outcomes
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-treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: