Preoperative Laser Depilation of Donor Site in Head and Neck Cancer Free Flap Reconstruction [LaDDoR]
Changes in Hair Density of the Free Flap Following Preoperative Laser Depilation of Donor Site in Head and Neck Cancer Free Flap Reconstruction [LaDDoR]
Chris O'Brien Lifehouse
70 participants
Mar 17, 2025
Interventional
Conditions
Summary
The purpose of this research is to determine the effectiveness of laser treatment on the leg or arm that will be used to reconstruct your mouth after a removal of cancer before the surgery in reducing hair density in the mouth, and to assess overall satisfaction, including comfort and oral hygiene post-surgery. Who is it for? You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo free flap reconstruction using hair-bearing donor site. Study Details: By participating in this study, you will be randomised to either the control group (no laser hair removal treatment) or the intervention group (laser hair removal treatment). Following your surgery, an assessment will be conducted while you are still in hospital to review your healing of donor site/free flap as a standard of care. Hair density measurements and a review of the free flap will also be conducted at your routine post operative review at 4 weeks and 12 weeks post-op. Functional and health-related quality of life [HRQOL] patient reported outcome data will be collected using the FACE-Q Head and Neck Module questionnaire at the first appointment and 12 weeks postop. It is hoped that findings from this study will help clinicians and researchers understand the utility of pre-operative laser treatment in improving quality of life for those undergoing head and neck reconstruction.
Eligibility
Inclusion Criteria3
- Willingness to give informed consent
- Patient undergoing major resection of the head and neck cancer with free flap reconstruction using hair-bearing donor site
- At least 18 years old
Exclusion Criteria6
- Refusal to participate in study
- Patient undergoing free flap reconstruction without hair-bearing cutaneous donor site
- Patient receiving post-operative radiotherapy
- Unable to complete follow up period of study
- History of photosensitivity, keloids, skin pigmentation disorder, seizure disorder triggered by light
- Use of systemic retinoids or light-sensitizing drugs in the previous 6 months
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Interventions
Primary objective is to compare changes in the hair density of the free flap at key points of reconstruction: preoperatively and postoperatively for intervention and control groups. Interventions include: Appointment 1: Approx. 3weeks preop Eligibility screen and Informed consent Hair density measurement. Hair density in your donor site will be measured by clipping the hair, placing a custom 3D printed “ruler” and taking the photographs which will take approximately 15 to 30 minutes. Functional and health-related quality of life [HRQOL] Questionnaire. which will take approximately 10 – 15 minutes Appointment 2 and 3: Laser treatment session (intervention group). Participants in the intervention group will undergo laser depilatory treatment to their donor site at Contour clinics, a laser clinic external to Chris O’Brien Lifehouse (no out-of-pocket cost for participant for laser treatment). A depilation guide marking the specific areas for laser treatment will be created and distributed to the laser technician. The first laser session will be completed within a week of signing the consent form (approximately 2.5 weeks before your surgery), and the second session will be completed at least 3 days prior to your surgery. The sessions will be roughly 2 weeks apart and this will allow adequate time for common acute effects, such as erythema and pain, to resolve. Each laser session will take approximately 60 minutes. A treatment questionnaire including adverse event assessment and a visual analogue pain scale assessing the tolerability of treatment will be completed by participants on the same day of the intervention (via online or paper form already provided to participants). This will take approximately 5 -10 minutes. Follow up: An inpatient assessment will be conducted day 5 (+/- 2 days) post-op to review flap in the recipient site and record post-operative complications. Hair density measurements at the recipient site and review of the donor site at 4- and 12-week routine postoperative clinic. The HRQOL questionnaire will be repeated at 12-week routine postoperative clinic or will be emailed/mailed to a participant. Other than the laser depilation to the donor site prior to surgery, patients will be treated as per the usual standard of care for head and neck cancer reconstruction.
Locations(1)
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ACTRN12625000040460