Androgenetic Alopecia, Wound Healing
Conditions
Keywords
Androgenetic Alopecia, Povidone-Iodine, Wound Healing, Scalp Antisepsis, Postoperative Care, Hair Transplantation, Rifamycin SV, Follicular Unit Extraction, Dermatology Nursing
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.
Detailed description
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.
Interventions
Preoperative skin antisepsis performed with 10% povidone-iodine solution according to standard surgical preparation guidelines before hair transplantation.
DRUGRifamycin SV Sodium
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.
Sponsors
Elif Asena KANTARCI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recorded Early Healing Category | Assessed from postoperative Day 1 through Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Crusting on Postoperative Day 14 | Postoperative Day 14 | Presence of persistent crusting before planned physician-approved cleaning on postoperative Day 14, recorded as present or absent during the standardized clinical wound assessment. |
| Erythema on Postoperative Day 7 | Postoperative Day 7 | Presence of erythema on postoperative Day 7, recorded as present or absent during the standardized clinical wound assessment. Erythema alone did not establish clinical infection. |
| Tenderness on Postoperative Day 14 | Postoperative Day 14 | Presence of tenderness on postoperative Day 14, recorded as present or absent during the standardized clinical wound assessment. |
| Clinical Infection and Rifamycin-Related Hypersensitivity | From intervention through postoperative Day 14 | Clinically confirmed infection was assessed based on progression or persistence together with findings such as purulent drainage, spreading inflammation, marked local heat, increasing pain, systemic findings, positive culture when obtained, or need for additional treatment. Localized or systemic hypersensitivity attributable to topical rifamycin SV was also monitored. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRFadime ÇINAR, Assoc. Prof.,PhD
Nisantasi University, School of Health Sciences, Department of Nursing
Outcome results
None listed