Clinical trial NCT05077592: Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
Official title: Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgical Site Infection
Surgical Wound Infection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Site Infection Incidence
timeFrame: 30 days
Secondary outcomes:
measure: Post-operative morbidity and mortality
timeFrame: 30 Days
measure: Length of hospital stay
timeFrame: 30 Days
measure: Readmission and reoperations related to Surgical site infection
timeFrame: 30 Days
measure: Infectious complications
timeFrame: 30 Days
measure: Microbiology culture and sensitivity results
timeFrame: 30 Days
measure: Local adverse events for povidone-iodine application
timeFrame: 30 Days
measure: Cost analysis
timeFrame: 30 Days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Ain Shams University
name: Waleed AbdelGhany, Professor
role: PRINCIPAL_INVESTIGATOR
References: