Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections

Surgical Site Infection Clinical Trial

Official title:

Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077592
• Other study ID #: POV-2021
• Status: Recruiting
• Phase: Phase 4
• Start date: September 18, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: October 2021
• Source: Ain Shams University
• Contact: Abdurrahman Abdelzaher
• Phone: +201126857234
• Email: a.t.abdelzaher[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections.

Description:

Surgical site infections are post-operative infections of the incision or organ or space that was included in the surgical field. Incisional surgical site infections (SSIs) are a growing healthcare challenge. Currently, up to 10% of surgical procedures may be complicated by an SSI [3]. Not only do SSIs lead to worse patient outcomes, but they also account for a large proportion of healthcare expenditure. In the United Kingdom alone, SSIs are estimated to cost the National Health Service 1 billion pounds annually. The problem is further compounded in low- and middle-income countries (LMICs) where the prevalence of antibiotic-resistant infections is increasing, and national healthcare budgets are strained. In fact, SSIs are estimated to account for additional costs of up to $30,000 in LMICs. The global crisis of drug-resistant bacteria has further highlighted the need for more effective perioperative preventive strategies to minimize healthcare-associated resistant infections. Optimal surgical antisepsis is critical in reducing the incidence of SSIs, and therefore in reducing the use of postoperative antibiotics. Recently, there has been a renewed interest in using povidone-iodine (PVI) intraoperative wound irrigation to achieve this goal. The choice of PVI is especially suitable for LMICs where the availability of chlorhexidine preparations may be limited by scarce resources. A possible adjunctive role of pre-wound closure PVI irrigation in reducing incisional SSIs is still unclear. A meta-analysis by López-Cano et al. analyzed data of 7,601 patients and found a reduction in overall SSI rate. However, the heterogeneity and uncertain quality of most studies limited the synthesis of conclusive evidence. The possible benefits of irrigating the surface of an open incision include local antimicrobial effect, physical removal of debris and dilution of contamination. Recent guidelines have all emphasized the lack of sufficient evidence on intraoperative use of PVI. The investigators aim to conduct a randomized controlled trial in Ain Shams University Hospitals to compare the effect of adding PVI wash prior to skin closure to direct wound closure on reducing the rates of SSIs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: January 18, 2022
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (= 18 years old)
• Open and minimally invasive surgeries
• Emergency (any unplanned admission) and elective (planned admission) surgical procedures
• Clean, Clean-Contaminated, Contaminated, Dirty wounds
• Inclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping

Exclusion Criteria:

• Povidone-iodine allergy
• Surgeries for infected wounds.
• Exclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• 10% Povidone Iodine
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection Incidence	Using the CDC Checklist for Superficial and deep Surgical site infection.	30 days
Secondary	Post-operative morbidity and mortality	Using the Clavien-Dindo classification system	30 Days
Secondary	Length of hospital stay	in days using the hospital records	30 Days
Secondary	Readmission and reoperations related to Surgical site infection	Using the hospital records, Number of reoperations and readmissions due to surgical site infection.	30 Days
Secondary	Infectious complications	Using qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence	30 Days
Secondary	Microbiology culture and sensitivity results	A microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.	30 Days
Secondary	Local adverse events for povidone-iodine application	Symptoms and sings	30 Days
Secondary	Cost analysis	In terms of extra hospital stay days and readmission days costs.	30 Days