Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
NCT ID: NCT05077592
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
760 participants
INTERVENTIONAL
2021-09-18
2022-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Control
Direct Wound closure
No interventions assigned to this group
Intervention
The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure
10% Povidone Iodine
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
Interventions
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10% Povidone Iodine
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Surgeries for infected wounds.
* Exclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping.
18 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Walid Ahmed Abdel-Ghany
Professor
Principal Investigators
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Waleed AbdelGhany, Professor
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Ain Shams University Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Waleed AbdelGhany, Professor
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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POV-2021
Identifier Type: -
Identifier Source: org_study_id