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NCT Number: NCT07155408

Combined Use of Povidone-Iodine and Rifampicin in Hair Transplantation

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Wound Healing

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bahcesehir University, School of Health Sciences, Department of Nursing

Istanbul, Besiktas, 34353, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Povidone-Iodine 10%

Drug

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

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.

Primary outcomes

  1. Postoperative wound infection rate

    Time frame: 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 outcomes

  1. Wound healing time

    Time frame: 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.

  2. Postoperative pain score

    Time frame: 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.

  3. Postoperative erythema score

    Time frame: 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).

  4. Incidence of allergic or hypersensitivity reactions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elif Asena KANTARCI

Other

Registry information

Official study title

The Effect of Combined Use of Povidone-Iodine and Rifampicin on Wound Healing and Infection Prevention in Scalp Antisepsis for Hair Transplantation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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