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

Phase 4

• Conditions: Surgical Site Infection; Surgical Wound Infection
• Interventions: Drug: 10% Povidone Iodine

• Registration Number: NCT05077592
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-09-18
• Study First Submitted: 2021-09-19
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-14
• Last Update Posted: 2021-10-14
• Primary Completion: 2021-12-18
• Study Completion: 2022-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 760

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	10% Povidone Iodine	The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection Incidence	30 days	Using the CDC Checklist for Superficial and deep Surgical site infection.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt