Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
1 other identifier
interventional
760
1 country
1
Brief Summary
A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2021
CompletedFirst Submitted
Initial submission to the registry
September 19, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2022
CompletedOctober 14, 2021
October 1, 2021
3 months
September 19, 2021
October 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical Site Infection Incidence
Using the CDC Checklist for Superficial and deep Surgical site infection.
30 days
Secondary Outcomes (7)
Post-operative morbidity and mortality
30 Days
Length of hospital stay
30 Days
Readmission and reoperations related to Surgical site infection
30 Days
Infectious complications
30 Days
Microbiology culture and sensitivity results
30 Days
- +2 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONDirect Wound closure
Intervention
ACTIVE COMPARATORThe use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure
Interventions
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Povidone-iodine allergy
- Surgeries for infected wounds.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Hospital
Cairo, 11591, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Waleed AbdelGhany, Professor
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 19, 2021
First Posted
October 14, 2021
Study Start
September 18, 2021
Primary Completion
December 18, 2021
Study Completion
January 18, 2022
Last Updated
October 14, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share