Clinical trial NCT06667089: Povidone-Iodine Versus Chlorhexidine in Surgical Wound Care
Official title: Comparison of Povidone-Iodine and Chlorhexidine in the Management of Iatrogenic Wounds in Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Up to twelve weeks
measure: EuroQol-5D (EQ-5D)
timeFrame: Up to twelve weeks
measure: Patient Satisfaction Questionnaire (PSQ)
timeFrame: Up to twelve weeks
measure: Wound Healing Assessment Tool
timeFrame: Up to twelve weeks
measure: Adverse Event Reporting Form
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to twelve weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: María Juana Millán Reyes
Study officials:
References: