Topical Rifamycin SV for Wound Healing After Sapphire FUE Hair Transplantation

NCT07155408 | Completed

• 2 other identifiers: BAU-EAS-2025-001E-22481095-020-1516
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, parallel-group controlled clinical study evaluated whether a single topical rifamycin SV protocol added to standardized care after sapphire follicular unit extraction (FUE) was associated with earlier recorded wound healing. One hundred candidates were assessed, and 70 men were individually allocated 1:1 using MedCalc. Five participants were excluded after allocation but before surgery and before receiving the assigned intervention because final preoperative serological testing met prespecified exclusion criteria. The analyzed sample comprised 34 participants in the rifamycin SV group and 31 in the control group. Healing was assessed through postoperative Day 14 using scheduled clinical review and serial photographs. Infection and hypersensitivity were monitored as safety outcomes.

Conditions

Androgenetic Alopecia; Wound Healing

Keywords

Androgenetic Alopecia; Povidone-Iodine; Wound Healing; Scalp Antisepsis; Postoperative Care; Hair Transplantation; Rifamycin SV; Follicular Unit Extraction; Dermatology Nursing

Outcome Measures

Primary Outcomes (1)

• Recorded Early Healing Category

  Each participant was assigned to the earliest interval in which the overall wound course was judged, by consensus of two masked physicians using serial clinical photographs, to have entered a healing category: 1-3 days, greater than 3-7 days, or greater than 7-14 days. Assessment integrated wound-bed and surrounding-skin appearance, bleeding or abnormal exudate, erythema, edema, tenderness, crusting, and spontaneous crust separation. These categories did not directly measure exact time to complete epithelialization.

  Assessed from postoperative Day 1 through Day 14

Secondary Outcomes (4)

• Persistent Crusting on Postoperative Day 14

  Postoperative Day 14

• Erythema on Postoperative Day 7

  Postoperative Day 7

• Tenderness on Postoperative Day 14

  Postoperative Day 14

• Clinical Infection and Rifamycin-Related Hypersensitivity

  From intervention through postoperative Day 14

Study Arms (2)

Standard Care Control

ACTIVE COMPARATOR

Participants received the standardized sapphire FUE protocol, including 10% povidone-iodine scalp antisepsis before surgery. Normal saline spray was applied to the donor area after graft harvesting and before dressing and to the recipient area after graft implantation was completed. Participants received the same postoperative nursing care, systemic medications, care products, washing instructions, and follow-up schedule as the experimental group.

Drug: Povidone-Iodine 10%

Topical Rifamycin SV

EXPERIMENTAL

Participants received the same standardized sapphire FUE protocol and preoperative 10% povidone-iodine scalp antisepsis as controls. One ampule of RIF containing rifamycin SV sodium 125 mg/1.5 mL was then used topically and off-label. The clinical nurse-investigator applied 0.75 mL dropwise to the donor surface after graft harvesting and before dressing and 0.75 mL to the recipient surface after graft implantation was completed. The solution was not injected.

Drug: Povidone-Iodine 10%; Drug: Rifamycin SV Sodium

Interventions

Povidone-Iodine 10% DRUG

Preoperative skin antisepsis performed with 10% povidone-iodine solution according to standard surgical preparation guidelines before hair transplantation.

Standard Care Control; Topical Rifamycin SV

Rifamycin SV Sodium DRUG

One complete ampule containing rifamycin SV sodium 125 mg/1.5 mL was drawn into a syringe and applied topically and off-label; it was not injected. The clinical nurse-investigator applied 0.75 mL dropwise to the donor surface after graft harvesting and before dressing and 0.75 mL to the recipient surface after graft implantation was completed. Each application was distributed with separately applied normal saline spray.

Also known as: RIF 125 mg/1.5 mL

Topical Rifamycin SV

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male participants older than 20 years
• Scheduled for a first hair transplantation session
• Deemed medically fit for the procedure
• Provided written informed consent

You may not qualify if:

• Diabetes or another chronic or systemic condition that could affect wound healing
• Heart failure or kidney failure
• Communicable disease
• Scalp disorder
• Recent antibiotic use
• Planned second hair transplantation session
• Absence of a medical fitness report
• Medication, antibiotic, rifamycin, or topical-solution allergy relevant to the protocol

Sponsors & Collaborators

• Elif Asena KANTARCI: lead

Study Sites (1)

Bahcesehir University, School of Health Sciences, Department of Nursing

Istanbul, Besiktas, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alopecia

Interventions

Rifamycins; Rifampin

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Fadime ÇINAR, Assoc. Prof.,PhD

  Nisantasi University, School of Health Sciences, Department of Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and both physicians who jointly assessed the clinical outcomes were unaware of group assignment. The clinical nurse-investigator generated and implemented the assignment, prepared and applied the intervention, and recorded the physicians' consensus and assessment data; this investigator was not masked, and allocation was not concealed from this investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Vocational School of Health Services

Model Details: Participants were assigned in a 1:1 ratio to two parallel groups. MedCalc was run separately for each consented participant to generate an individual assignment to topical rifamycin SV or control; allocation was not based on alternation. Five of 70 allocated participants were excluded before surgery and before receiving the assigned intervention after final preoperative serological testing met prespecified exclusion criteria.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 4, 2025
• Study Start: December 2, 2021
• Primary Completion: May 15, 2022
• Study Completion: June 22, 2022
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

TU (1)