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

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

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound Infection; Surgical Site Infection
• Intervention / Treatment: Drug: 10% Povidone Iodine

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 Type: Interventional
• Enrollment (Anticipated): 760
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Abdurrahman Abdelzaher; Phone Number: +201126857234; Email: a.t.abdelzaher@gmail.com
• Study Contact Backup: Name: Emad Alazab; Phone Number: 201063705669; Email: emp14.emad.e.alazab@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University Hospital
    • Contact: Waleed AbdelGhany, Professor
    • Sub-Investigator: Seif Tarek
    • Sub-Investigator: Ibrahim El Garhy
    • Principal Investigator: Mohamed Bahaa, Professor
    • Principal Investigator: Reda Abdelttawab Essa, Professor
    • Sub-Investigator: Salma Ramadan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Direct Wound closure
Active Comparator: Intervention; The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure	Drug: 10% Povidone Iodine; Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.; Other Names: betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Infection Incidence	Using the CDC Checklist for Superficial and deep Surgical site infection.	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Waleed AbdelGhany, Professor, ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2021
• Primary Completion (Anticipated): December 18, 2021
• Study Completion (Anticipated): January 18, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: October 10, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: POV-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No