Topical Rifamycin SV for Wound Healing After Sapphire FUE Hair Transplantation

All procedures were performed in one private hair transplantation clinic between December 2021 and May 2022 using the same sapphire FUE technique, clinical team, equipment, antisepsis, systemic medications, care products, washing instructions, and follow-up protocol. MedCalc was run separately for each consented participant to generate an individual 1:1 assignment. The clinical nurse-investigator generated and implemented allocation and was not masked; allocation was not concealed from this investigator. Participants and the two physicians who jointly assessed clinical healing were unaware of group assignment.

Both groups received approximately 50 mL of 10% povidone-iodine on the donor and recipient areas before surgery, followed by normal saline cleansing. The experimental group then received one ampule of RIF containing rifamycin SV sodium 125 mg/1.5 mL. The solution was used topically and off-label and was not injected. It was divided equally: 0.75 mL was applied dropwise to the donor surface after graft harvesting and before dressing, and 0.75 mL was applied to the recipient surface after graft implantation was completed. The control group received normal saline spray at the corresponding donor- and recipient-area time points.

The primary clinical outcome was the earliest interval in which the overall wound course was judged, by masked physician consensus and serial photographs, to have entered one of three recorded healing categories: 1-3 days, greater than 3-7 days, or greater than 7-14 days. The assessment integrated wound-bed and surrounding-skin appearance, bleeding or abnormal exudate, erythema, edema, tenderness, crusting, and spontaneous crust separation. The categories were not validated specifically for FUE and did not directly measure exact time to complete epithelialization. Persistent crusting on Day 14 was supportive; erythema on Day 7 and tenderness on Day 14 were exploratory. Clinically confirmed infection and rifamycin-related hypersensitivity were monitored as safety outcomes. All analyzed participants received ciprofloxacin 500 mg twice daily for 7 days, so the study was not designed to determine an independent anti-infective effect of topical rifamycin SV.

Inclusion criteria

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

Exclusion criteria

• 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