Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Development and Clinical Validation of an Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
- General good health with no contraindications to minor outpatient surgery under local anesthesia.
- Willingness and ability to provide written informed consent and comply with the full 12-month follow-up schedule.
Exclusion Criteria:
- 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).
- Immunosuppression or current use of immunosuppressive medication.
- Endocrine disorders directly causing hair loss (e.g., uncontrolled thyroid disease) or active telogen effluvium.
- Psychiatric illness affecting the capacity to provide informed consent or comply with follow-up, or unrealistic patient expectations.
- Previous hair transplantation in the same donor or recipient area within the preceding 12 months.
- Known hypersensitivity to local anesthetics used in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Integrated Protocol Group
Participants undergo follicular unit extraction (FUE) using a standardized, evidence-based perioperative workflow. This includes algorithmic punch selection (0.8-1.0 mm) based on donor hair caliber and scalp characteristics, pre-set extraction depth (2.5-4 mm) and natural exit angulation, atraumatic microsurgical forceps handling, chilled holding solution maintained at 4 °C, strict time-stamping with graft out-of-body time targeted to ≤2-4 hours, and standardized recipient site implantation density (30-50 FU/cm²). |
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. |
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Actieve vergelijker: Standard FUE Practice Group
Participants undergo follicular unit extraction (FUE) according to routine departmental practice, where punch selection, harvesting depth, extraction angle, and graft handling/storage procedures are performed according to the operating surgeon's standard, non-standardized routine. All perioperative medications and post-operative care instructions remain identical to the experimental arm. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Hair Follicle Survival Rate
Tijdsspanne: 12 months postoperatively
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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%. |
12 months postoperatively
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FUE Follicle Survival Protocol
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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