Surgical Site InfectionPhase 4NCT05077592
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
A Phase 4 study testing 10% Povidone Iodine in people with Surgical Site Infection and Surgical Wound Infection, run by Ain Shams University at 1 site in Egypt.
Trial summary
A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Surgical Wound Infection
- What is being tested?
- 10% Povidone Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Sep 2021to 18 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo, 11591
Waleed AbdelGhany, Professor
Seif Tarek
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Site Infection, Surgical Wound Infection
- Being tested
- 10% Povidone Iodine
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Povidone IodineDrug
Also called betadine
Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Direct Wound closure |
| Intervention | Active comparator | The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure Receives: Drug: 10% Povidone Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Incidence
Using the CDC Checklist for Superficial and deep Surgical site infection.
Measured: 30 days
Secondary outcomes (7)
Post-operative morbidity and mortality
Using the Clavien-Dindo classification system
Measured: 30 Days
Length of hospital stay
in days using the hospital records
Measured: 30 Days
Readmission and reoperations related to Surgical site infection
Using the hospital records, Number of reoperations and readmissions due to surgical site infection.
Measured: 30 Days
Infectious complications
Using qSOFA and SOFA score. such as Sepsis, septic shock, multiple-organ dysfunction syndrome, wound dehiscence
Measured: 30 Days
Microbiology culture and sensitivity results
A microbiology report that contains the exact pathogen strain and antibiotic sensitivity report.
Measured: 30 Days
Local adverse events for povidone-iodine application
Symptoms and sings
Measured: 30 Days
Cost analysis
In terms of extra hospital stay days and readmission days costs.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start18 Sep 2021
- Primary completion18 Dec 2021 (estimated)
- Study completion18 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Ahmed Abdel-Ghany, Ain Shams University
- Investigators
- Waleed AbdelGhany, Professor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077592
- Sponsor's protocol ID
- POV-2021
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05077592
- Acronym / sponsor ID
- POV-2021
- Conditions
- Surgical Site Infection, Surgical Wound Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Sep 2021 (actual)
- Primary completion
- 18 Dec 2021 (estimated)
- Study completion
- 18 Jan 2022 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Direct Wound closure |
| Intervention | Active comparator | Drug: 10% Povidone IodineThe use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Povidone IodineAlso: betadinePovidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds. | Drug | Intervention |
Primary outcome
Surgical Site Infection Incidence
Time frame: 30 days
Using the CDC Checklist for Superficial and deep Surgical site infection.
7 secondary outcomes
Post-operative morbidity and mortality
Time frame: 30 Days
Length of hospital stay
Time frame: 30 Days
Readmission and reoperations related to Surgical site infection
Time frame: 30 Days
Infectious complications
Time frame: 30 Days
Microbiology culture and sensitivity results
Time frame: 30 Days
Local adverse events for povidone-iodine application
Time frame: 30 Days
Cost analysis
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed AbdelGhany, Professor principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 10% Povidone Iodine in people with Surgical Site Infection and Surgical Wound Infection, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdurrahman Abdelzaher (+201126857234, a.t.abdelzaher@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection Incidence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.