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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05077592
Enrollment
760
Registered
2021-10-14
Start date
2021-09-18
Completion date
2022-01-18
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection, Surgical Wound Infection

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.

Interventions

Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site Infection Incidence30 daysUsing the CDC Checklist for Superficial and deep Surgical site infection.

Secondary

MeasureTime frameDescription
Length of hospital stay30 Daysin days using the hospital records
Readmission and reoperations related to Surgical site infection30 DaysUsing the hospital records, Number of reoperations and readmissions due to surgical site infection.
Infectious complications30 DaysUsing qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence
Post-operative morbidity and mortality30 DaysUsing the Clavien-Dindo classification system
Local adverse events for povidone-iodine application30 DaysSymptoms and sings
Cost analysis30 DaysIn terms of extra hospital stay days and readmission days costs.
Microbiology culture and sensitivity results30 DaysA microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.

Countries

Egypt

Contacts

Primary ContactAbdurrahman Abdelzaher
a.t.abdelzaher@gmail.com+201126857234
Backup ContactEmad Alazab
emp14.emad.e.alazab@gmail.com201063705669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026