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Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Sponsor: Assiut University
Summary
Follicular unit extraction (FUE) is a widely used surgical technique for hair restoration, yet hair follicle survival rates vary depending on surgical instrumentation, graft handling, and perioperative care. The purpose of this clinical trial is to evaluate whether an evidence-based, integrated perioperative protocol maximizes hair follicle graft survival compared with standard departmental practice in male patients undergoing FUE for androgenetic alopecia or localized scarring alopecia. Participants will be randomly assigned to one of two groups: * Integrated Protocol Group: Patients receive FUE surgery guided by a standardized workflow featuring algorithmic punch selection (0.8-1.0 mm), pre-set extraction depth and angulation, chilled holding solutions maintained at 4 °C, strict graft out-of-body time limits (target ≤2-4 hours), and standardized recipient site implantation. * Standard FUE Practice Group: Patients receive FUE surgery according to routine departmental practice, where punch selection, harvesting parameters, and graft handling follow the operating surgeon's standard routine. Follicle survival and hair density will be tracked using digital trichoscopy in pre-marked 1×1 cm reference scalp areas over a 12-month follow-up period. Investigators will also assess intraoperative follicular transection rates, procedural complications, and patient satisfaction between the two groups.
Official title: Development and Clinical Validation of an Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Key Details
Gender
MALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10
Completion Date
2027-11
Last Updated
2026-09-30
Healthy Volunteers
No
Interventions
Integrated Evidence-Based FUE Protocol
A standardized perioperative FUE protocol consisting of: algorithmic micromotor punch selection (0.8-1.0 mm diameter; sharp, blunt, or serrated/trumpet-shaped) based on hair caliber, curl, and scalp laxity; pre-set extraction depth (2.5-4.0 mm) aligned with natural hair exit angles; atraumatic graft extraction using Foerster-type microsurgical forceps; graft preservation in a chilled holding solution maintained at 4 °C; strict monitoring targeting total out-of-body time to ≤2-4 hours; and standardized recipient site creation and implantation (30-50 FU/cm²) via micro-blades or Choi-type implanter pens.
Standard FUE Practice
Conventional follicular unit extraction performed according to routine departmental practice, wherein extraction punch selection, harvesting depth, incision angles, graft holding conditions, and out-of-body handling times are determined based on the operating surgeon's individual routine without standardized protocolized constraints. Postoperative care and medical regimens remain identical to the experimental arm.