Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)

ConditionsAndrogenetic Alopecia Cicatricial Alopecia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

Age18-60

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients aged 18 to 60 years.

Clinically diagnosed androgenetic alopecia (Norwood-Hamilton grade II-V) or localized scarring alopecia suitable for follicular unit extraction (FUE).

Adequate donor area hair density (≥ 40 FU/cm²) confirmed by trichoscopic evaluation.

Minimal or no response to at least 6 months of medical treatment (e.g., topical minoxidil, oral finasteride), where applicable.

Disqualifiers

Active scalp infection, dermatitis, or other active dermatological disease at the donor or recipient site.

History or tendency of keloid or hypertrophic scarring.

Bleeding diathesis or current use of anticoagulant/antiplatelet therapy that cannot be safely discontinued.

Uncontrolled systemic disease (e.g., uncontrolled diabetes mellitus, cardiovascular, hepatic, renal, or pulmonary disease).

Trial design

Design model

Parallel

Treatments tested in this trial

Integrated Evidence-Based FUE Protocol
Procedure/Surgery
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
Procedure/Surgery
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Integrated Protocol GroupExperimental treatment 1 intervention

Group B: Standard FUE Practice GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Hair Follicle Survival Rate

Hair follicle graft survival rate assessed within the pre-marked 1×1 cm recipient study reference boxes using digital trichoscopy. The survival percentage is calculated using the following formula: \[(Number of follicles counted at 12 months - baseline follicle count in recipient area) ÷ (Number of grafts transplanted into the reference box)\] × 100%.

Time frame

12 months postoperatively

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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