Combined Use of Povidone-Iodine and Rifampicin in Hair Transplantation

Not Applicable

Completed

• Conditions: Androgenetic Alopecia; Wound Healing
• Interventions: Drug: Povidone-Iodine 10%; Drug: Povidone-Iodine + Rifampicin

• Registration Number: NCT07155408
• Lead Sponsor: Elif Asena KANTARCI

Brief Summary

This randomized controlled clinical trial was designed to evaluate the effectiveness of combining 10% povidone-iodine with 125 mg rifampicin for preoperative scalp antisepsis in hair transplantation procedures. The study was conducted in a private hair transplantation clinic between December 2021 and May 2022. A total of 65 adult patients meeting the inclusion criteria were enrolled and randomly assigned to one of two groups: the experimental group (n=34), which received the combined povidone-iodine plus rifampicin protocol, and the control group (n=31), which received povidone-iodine alone as the standard preoperative antisepsis protocol.

Data collection included the use of standardized forms, intraoperative and postoperative observation records, and photographic documentation. Follow-up assessments were performed on postoperative days 3, 7, and 14. The primary aim of the study was to assess the potential of this combined antiseptic protocol to improve wound care and infection prevention practices in hair transplantation surgery.

Detailed Description

This study was designed to evaluate the effect of the combined use of povidone-iodine and rifampicin for scalp antisepsis in hair transplantation. The study employed a randomized controlled design, involving adult patients undergoing elective hair transplantation procedures. Participants were randomly assigned to an experimental group receiving the combined antisepsis protocol or a control group receiving standard povidone-iodine alone.

The inclusion criteria included patients over 18 years of age, undergoing elective hair transplantation, and providing informed consent. Exclusion criteria included hypersensitivity to the antiseptic agents or active dermatological conditions on the scalp.

The antiseptic agents were applied preoperatively before the transplantation procedure. Patients were monitored postoperatively at scheduled intervals, and the antisepsis process was documented using standardized photographic assessments.

The total sample included 65 patients. The study duration involved approximately 14 days of follow-up. No interim analysis was conducted. The study protocol was approved by the Bahcesehir University Clinical Research Ethics Committee.

This clinical protocol aims to contribute to the evidence base regarding the use of combination antiseptic protocols in minor surgical procedures.

Study Timeline

• Study Start: 2021-12-02
• Primary Completion: 2022-05-15
• Study Completion: 2022-06-22
• Study First Submitted: 2025-08-14
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 65

Inclusion Criteria

• Age 18 years or older
• Individuals scheduled for hair transplantation surgery
• Fitzpatrick skin type between I and IV
• Willingness to participate and sign the written informed consent form
• Overall health status suitable for the procedure (after preoperative evaluation)

Exclusion Criteria

• Presence of active infection, open wound, or dermatological disease at the surgical site
• Systemic infection or immunosuppressive disorders
• Known allergy or sensitivity to povidone-iodine or rifampicin
• Bleeding disorders or current use of anticoagulant therapy
• Pregnancy or breastfeeding
• History of hair transplantation or similar surgical procedure within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Povidone-Iodine Antisepsis Protocol	Povidone-Iodine 10%	Participants receive preoperative skin antisepsis using the standard povidone-iodine protocol. The antiseptic is applied according to standard surgical preparation guidelines prior to hair transplantation procedures. Outcomes are measured postoperatively following the standard clinical follow-up schedule.
Combined Povidone-Iodine and Rifampicin Protocol	Povidone-Iodine 10%	Participants receive preoperative skin antisepsis using a combination of povidone-iodine and rifampicin solution. The antiseptic mixture is applied according to study-specific preparation guidelines prior to hair transplantation procedures. Outcomes are measured postoperatively following the standard clinical follow-up schedule.
Combined Povidone-Iodine and Rifampicin Protocol	Povidone-Iodine + Rifampicin	Participants receive preoperative skin antisepsis using a combination of povidone-iodine and rifampicin solution. The antiseptic mixture is applied according to study-specific preparation guidelines prior to hair transplantation procedures. Outcomes are measured postoperatively following the standard clinical follow-up schedule.

Primary Outcome Measures

Name	Time	Method
Postoperative wound infection rate	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.

Secondary Outcome Measures

Name	Time	Method
Wound healing time	Assessed daily until complete epithelialization, up to 14 days post-operation.	Number of days required for complete epithelialization of the donor and recipient sites, assessed by visual inspection and patient report. Complete epithelialization is defined as the absence of open wound areas and formation of intact skin.
Postoperative pain score	24 hours, 72 hours, and 7 days post-operation.	Pain intensity reported by the patient using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst possible pain) at donor and recipient sites.
Postoperative erythema score	24 hours, 72 hours, and 7 days post-operation.	Degree of redness at the donor and recipient sites, scored by the investigator using a standardized erythema grading scale (0-3, where 0 = none, 3 = severe).
Incidence of allergic or hypersensitivity reactions	Within 14 days post-operation.	Number of patients developing localized or systemic hypersensitivity reactions (e.g., rash, itching, swelling, anaphylaxis) following application of antiseptic solutions.

Trial Locations

Locations (1)

Bahcesehir University, School of Health Sciences, Department of Nursing; Istanbul, Besiktas, Turkey (Türkiye)