Povidone-Iodine Versus Chlorhexidine in Surgical Wound Care

NCT ID: NCT06667089

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2025-04-04

Brief Summary

This comparison examines the effectiveness of povidone-iodine and chlorhexidine in managing iatrogenic wounds in surgical patients. Both antiseptics are commonly used to prevent postoperative infections, but they differ in mechanism, efficacy, and safety profiles. Povidone-iodine releases iodine, which acts broadly against bacteria, viruses, and fungi, while chlorhexidine disrupts cell membranes, providing rapid bactericidal action. Studies suggest that chlorhexidine may offer longer-lasting antibacterial effects, but povidone-iodine has a wider antimicrobial range. Optimal choice depends on patient needs, wound type, and potential for adverse reactions, emphasizing the need for tailored antiseptic strategies in wound care.

Conditions

Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Povidone-Iodine Group

The povidone-iodine group will receive applications of 10% povidone-iodine solution or gel directly on the wound area involving a gentle cleaning of the wound followed by the application of povidone-iodine left on for a brief period to maximize its antimicrobial action with treatment applied according to protocol frequency, such as twice daily or as clinically indicated, with close monitoring for any adverse reactions or signs of infection

Group Type: EXPERIMENTAL

Povidone-Iodine

Intervention Type: OTHER

The povidone-iodine group will receive a 10% povidone-iodine solution or gel applied directly to the wound after gentle cleaning, with the treatment applied according to a set frequency, typically twice daily. This antiseptic will be left on the wound for a brief period to enhance its antimicrobial action.

Chlorhexidine Group

The chlorhexidine group will receive applications of chlorhexidine solution, typically at a concentration of 0.5% to 2%, also following a gentle cleaning of the wound area before applying chlorhexidine, which will remain on the wound according to protocol guidelines with a similar frequency and monitoring approach to assess for antimicrobial effectiveness, wound healing progress, and potential skin irritation

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: OTHER

The chlorhexidine group will receive a chlorhexidine solution, usually at a concentration of 0.5% to 2%, applied similarly after cleaning the wound. This solution will remain on the wound according to protocol guidelines, also typically applied twice daily. Both groups will be monitored for adverse reactions, signs of infection, and the overall effectiveness of wound healing throughout the treatment period.

Interventions

Povidone-Iodine

The povidone-iodine group will receive a 10% povidone-iodine solution or gel applied directly to the wound after gentle cleaning, with the treatment applied according to a set frequency, typically twice daily. This antiseptic will be left on the wound for a brief period to enhance its antimicrobial action.

Intervention Type: OTHER

Chlorhexidine

The chlorhexidine group will receive a chlorhexidine solution, usually at a concentration of 0.5% to 2%, applied similarly after cleaning the wound. This solution will remain on the wound according to protocol guidelines, also typically applied twice daily. Both groups will be monitored for adverse reactions, signs of infection, and the overall effectiveness of wound healing throughout the treatment period.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Elderly patients undergoing surgical procedures resulting in iatrogenic wounds (surgical wounds of various specialties, such as abdominal, orthopedic, cardiovascular, etc.).
• Availability for follow-up during the postoperative period, ensuring attendance at medical check-ups for the evaluation of healing and prevention of infections.
• Ability to provide informed consent, understanding the objectives, risks and benefits of the study.
• Absence of previous infections at the surgical site, ensuring that the wounds are recent and derived from the current surgical procedure.

Exclusion Criteria

• Known allergies or hypersensitivity to povidone iodine or chlorhexidine, to avoid risks of serious adverse reactions.
• Immunocompromised patients, such as those with advanced HIV, on immunosuppressant treatment, or with decompensated chronic diseases (poorly controlled diabetes, kidney failure, etc.), due to increased susceptibility to infections and altered healing.
• Patients with active infections or infected wounds prior to surgery, to avoid biasing the results by pre-existing infections.
• Pregnancy or breastfeeding, due to safety considerations and the possible alteration of healing and immunity processes during these stages.
• Use of other antiseptics or topical treatments at the wound site that may interfere with the efficacy of povidone iodine or chlorhexidine.
• Patients with known wound healing disorders (such as autoimmune diseases or hematological disorders), which may affect the results in terms of healing time and quality.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

María Juana Millán Reyes

Jaén, , Spain

Countries

Spain

Other Identifiers

University of Jaén¨

Identifier Type: -

Identifier Source: org_study_id