A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
760
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
Ain Shams University Hospital
Cairo, Egypt
RECRUITINGSurgical Site Infection Incidence
Using the CDC Checklist for Superficial and deep Surgical site infection.
Time frame: 30 days
Post-operative morbidity and mortality
Using the Clavien-Dindo classification system
Time frame: 30 Days
Length of hospital stay
in days using the hospital records
Time frame: 30 Days
Readmission and reoperations related to Surgical site infection
Using the hospital records, Number of reoperations and readmissions due to surgical site infection.
Time frame: 30 Days
Infectious complications
Using qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence
Time frame: 30 Days
Microbiology culture and sensitivity results
A microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.
Time frame: 30 Days
Local adverse events for povidone-iodine application
Symptoms and sings
Time frame: 30 Days
Cost analysis
In terms of extra hospital stay days and readmission days costs.
Time frame: 30 Days
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