Combined Use of Povidone-Iodine and Rifampicin in Hair Transplantation

NCT07155408 | Completed

• 2 other identifiers: BAU-EAS-2025-001E-22481095-020-1516
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia; Wound Healing

Keywords

Androgenetic Alopecia; Povidone-Iodine; Rifampicin; Wound Healing; Scalp Antisepsis; Postoperative Care; Hair Transplantation

Outcome Measures

Primary Outcomes (1)

• Postoperative wound infection rate

  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.

  Within 14 days post-operation

Secondary Outcomes (4)

• 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.

Study Arms (2)

Standard Povidone-Iodine Antisepsis Protocol

ACTIVE COMPARATOR

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.

Drug: Povidone-Iodine 10%

Combined Povidone-Iodine and Rifampicin Protocol

EXPERIMENTAL

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.

Drug: Povidone-Iodine 10%; Drug: Povidone-Iodine + Rifampicin

Interventions

Povidone-Iodine 10% DRUG

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

Combined Povidone-Iodine and Rifampicin Protocol; Standard Povidone-Iodine Antisepsis Protocol

Povidone-Iodine + Rifampicin DRUG

Preoperative skin antisepsis performed with a combination of 10% povidone-iodine and rifampicin solution according to study-specific preparation guidelines before hair transplantation.

Combined Povidone-Iodine and Rifampicin Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

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

Povidone-Iodine; 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)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; 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: NONE
• Masking Details: Due to the visible nature of antiseptic application methods, no blinding was performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Vocational School of Health Services

Model Details: Participants were randomly assigned to two parallel groups: one receiving the standard povidone-iodine antisepsis protocol and the other receiving the combined povidone-iodine and rifampicin protocol. Outcomes were measured simultaneously in both groups.

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 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)