Dermabrasion for Free Flap Aesthetic Enhancement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dermabrasion.
- Who it may be relevant to
- Registry conditions: Scar Conditions and Fibrosis of Skin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serial Dermabrasion for Aesthetic Enhancement of Free Flap Skin Paddles and Donor Sites: A Prospective Split-Flap/Scar Controlled Study
Overview
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.
Interventions
- Device Dermabrasion
This is the only intervention. Free flap scars will be split and half treated, half untreated then outcomes graded.
Primary outcome measures
- Aesthetic grading of treated area compared to untreated [Time frame: 1, 3, and 6 months post-treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07233200 · 00027645