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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05077592

Collaborator

(none)

760

Enrollment

Location

Arms

Anticipated Duration (Months)

189.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Surgical Wound Infection	Drug: 10% Povidone Iodine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

760 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

A statistician not directly involved in the study or analysis will prepare a computer-generated randomization sequence. No blocking will be used. The sequence will be provided to the trialists in the form of serially numbered opaque envelopes containing details of either the intervention or the control and a random identifier.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 18, 2021

Anticipated Primary Completion Date :

Dec 18, 2021

Anticipated Study Completion Date :

Jan 18, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Surgical Site Infection Incidence [30 days]
Using the CDC Checklist for Superficial and deep Surgical site infection.

Secondary Outcome Measures

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
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.
Local adverse events for povidone-iodine application [30 Days]
Symptoms and sings
Cost analysis [30 Days]
In terms of extra hospital stay days and readmission days costs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.