Povidone-Iodine Versus Chlorhexidine in Surgical Wound Care

NCT06667089 | Completed

• 1 other identifier: University of Jaén¨
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Numerical Rating Scale (NRS)

  The Numerical Rating Scale is a pain assessment tool where patients rate their pain intensity on a scale from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst possible pain." The interpretation of the scores is categorized into levels of pain severity: a score of 0-3 denotes mild pain, 4-6 indicates moderate pain, and 7-10 reflects severe pain. This categorization allows healthcare providers to gauge the patient's pain experience effectively, guiding treatment decisions and evaluating the efficacy of pain management strategies.

  Up to twelve weeks

• EuroQol-5D (EQ-5D)

  The EuroQol-5D is a standardized instrument for measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The results yield a single index score that typically ranges from -0.594 (worse than death) to 1 (optimal health). Scores are interpreted as follows: 0.0 signifies an average quality of life, 0.5 to 0.8 indicates moderate impairment, and 0.9 to 1.0 reflects high quality of life. These scores are essential for assessing the impact of interventions on patient quality of life.

  Up to twelve weeks

• Patient Satisfaction Questionnaire (PSQ)

  The Patient Satisfaction Questionnaire assesses patient satisfaction with healthcare services, using a scale from 1 to 5, where 1 represents "very dissatisfied" and 5 indicates "very satisfied." Interpretation of the scores categorizes satisfaction levels: 1-2 denotes low satisfaction, 3 represents average satisfaction, and 4-5 indicates high satisfaction. Higher scores suggest improvements in service quality and patient care, providing valuable feedback for healthcare providers to enhance their practices.

  Up to twelve weeks

• Wound Healing Assessment Tool

  This tool encompasses various metrics for evaluating wound characteristics, such as size, depth, and signs of infection. Interpretation of the results varies depending on the specific metrics used, but generally, a decrease in wound size and the absence of infection signs signify effective healing. Conversely, the presence of necrosis or an increase in wound size may indicate complications. Higher scores typically correlate with better healing outcomes, guiding clinicians in treatment decisions and monitoring progress.

  Up to twelve weeks

• Adverse Event Reporting Form

  This form is used to document any adverse reactions or events experienced by patients during treatment. The results are analyzed to calculate the incidence rate of adverse events, with lower rates suggesting that the treatment is safe and well-tolerated. Conversely, a higher frequency of adverse events may indicate safety concerns, prompting further investigation and potential modifications in treatment protocols. These findings are critical for evaluating the safety profile of interventions and informing clinical practice.

  Up to twelve weeks

Secondary Outcomes (2)

• Hospital Anxiety and Depression Scale (HADS)

  Up to twelve weeks

• Pittsburgh Sleep Quality Index (PSQI)

  Up to twelve weeks

Study Arms (2)

Povidone-Iodine Group

EXPERIMENTAL

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

Other: Povidone-Iodine

Chlorhexidine Group

EXPERIMENTAL

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

Other: Chlorhexidine

Interventions

Povidone-Iodine 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.

Povidone-Iodine Group

Chlorhexidine 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.

Chlorhexidine Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

María Juana Millán Reyes

Jaén, 23007, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Povidone-Iodine; Chlorhexidine

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; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: January 7, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 4, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

ES (1)