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

October 10, 2021 updated by: Walid Ahmed Abdel-Ghany, Ain Shams University

Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections: A Randomized Controlled Trial

A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
760

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Recruiting
        • Ain Shams University Hospital
        • Contact:
          • Waleed AbdelGhany, Professor
        • Sub-Investigator:
          • Seif Tarek
        • Sub-Investigator:
          • Ibrahim El Garhy
        • Principal Investigator:
          • Mohamed Bahaa, Professor
        • Principal Investigator:
          • Reda Abdelttawab Essa, Professor
        • Sub-Investigator:
          • Salma Ramadan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Direct Wound closure
Active Comparator: Intervention
The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure
Drug: 10% Povidone Iodine
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
Other Names:
  • betadine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical Site Infection Incidence
Time Frame: 30 days
Using the CDC Checklist for Superficial and deep Surgical site infection.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-operative morbidity and mortality
Time Frame: 30 Days
Using the Clavien-Dindo classification system
30 Days
Length of hospital stay
Time Frame: 30 Days
in days using the hospital records
30 Days
Readmission and reoperations related to Surgical site infection
Time Frame: 30 Days
Using the hospital records, Number of reoperations and readmissions due to surgical site infection.
30 Days
Infectious complications
Time Frame: 30 Days
Using qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence
30 Days
Microbiology culture and sensitivity results
Time Frame: 30 Days
A microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.
30 Days
Local adverse events for povidone-iodine application
Time Frame: 30 Days
Symptoms and sings
30 Days
Cost analysis
Time Frame: 30 Days
In terms of extra hospital stay days and readmission days costs.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Waleed AbdelGhany, Professor, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • POV-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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