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Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections

Primary Purpose

Surgical Site Infection, Surgical Wound Infection

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
10% Povidone Iodine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm Description

Direct Wound closure

The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure

Outcomes

Primary Outcome Measures

Surgical Site Infection Incidence
Using the CDC Checklist for Superficial and deep Surgical site infection.

Secondary Outcome Measures

Post-operative morbidity and mortality
Using the Clavien-Dindo classification system
Length of hospital stay
in days using the hospital records
Readmission and reoperations related to Surgical site infection
Using the hospital records, Number of reoperations and readmissions due to surgical site infection.
Infectious complications
Using qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence
Microbiology culture and sensitivity results
A microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.
Local adverse events for povidone-iodine application
Symptoms and sings
Cost analysis
In terms of extra hospital stay days and readmission days costs.

Full Information

First Posted
September 19, 2021
Last Updated
October 10, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05077592
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2021 (Actual)
Primary Completion Date
December 18, 2021 (Anticipated)
Study Completion Date
January 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Surgical Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Direct Wound closure
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure
Intervention Type
Drug
Intervention Name(s)
10% Povidone Iodine
Other Intervention Name(s)
betadine
Intervention Description
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
Primary Outcome Measure Information:
Title
Surgical Site Infection Incidence
Description
Using the CDC Checklist for Superficial and deep Surgical site infection.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Post-operative morbidity and mortality
Description
Using the Clavien-Dindo classification system
Time Frame
30 Days
Title
Length of hospital stay
Description
in days using the hospital records
Time Frame
30 Days
Title
Readmission and reoperations related to Surgical site infection
Description
Using the hospital records, Number of reoperations and readmissions due to surgical site infection.
Time Frame
30 Days
Title
Infectious complications
Description
Using qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence
Time Frame
30 Days
Title
Microbiology culture and sensitivity results
Description
A microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.
Time Frame
30 Days
Title
Local adverse events for povidone-iodine application
Description
Symptoms and sings
Time Frame
30 Days
Title
Cost analysis
Description
In terms of extra hospital stay days and readmission days costs.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdurrahman Abdelzaher
Phone
+201126857234
Email
a.t.abdelzaher@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emad Alazab
Phone
201063705669
Email
emp14.emad.e.alazab@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed AbdelGhany, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waleed AbdelGhany, Professor
First Name & Middle Initial & Last Name & Degree
Seif Tarek
First Name & Middle Initial & Last Name & Degree
Ibrahim El Garhy
First Name & Middle Initial & Last Name & Degree
Mohamed Bahaa, Professor
First Name & Middle Initial & Last Name & Degree
Reda Abdelttawab Essa, Professor
First Name & Middle Initial & Last Name & Degree
Salma Ramadan

12. IPD Sharing Statement

Plan to Share IPD
No

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Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections

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