Topical Rifamycin SV After Sapphire FUE: Accelerated Wound Healing and Anticipatory and Preventive Nursing Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Postoperative wound infection rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants older than 20 years
- •Scheduled for a first hair transplantation session
- •Deemed medically fit for the procedure
- •Provided written informed consent
排除标准
- •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
研究组 & 干预措施
Topical Rifamycin SV
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.
干预措施: Rifamycin SV Sodium (Drug)
Standard Care Control
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.
干预措施: Povidone-Iodine 10% (Drug)
Topical Rifamycin SV
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.
干预措施: Povidone-Iodine 10% (Drug)
结局指标
主要结局
Postoperative wound infection rate
时间窗: Within 14 days post-operation
Incidence of clinically diagnosed postoperative wound infection, defined by the presence of redness, swelling, tenderness, purulent discharge, or positive bacterial culture, following hair transplantation procedures. Infection will be confirmed based on clinical examination by a qualified physician.
Recorded Early Healing Category
时间窗: 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.
次要结局
- Wound healing time(Assessed daily until complete epithelialization, up to 14 days post-operation.)
- Postoperative pain score(24 hours, 72 hours, and 7 days post-operation.)
- Postoperative erythema score(24 hours, 72 hours, and 7 days post-operation.)
- Incidence of allergic or hypersensitivity reactions(Within 14 days post-operation.)
- 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)
研究者
Elif Asena KANTARCI
Lecturer, Vocational School of Health Services
Bahçeşehir University