Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection

NCT ID: NCT05090176

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participant recruitment and randomisation based on eligibility based on CONSORT.

Patient will get either package A or B which determine whether they are getting povidone-soaked suture or ordinary suture during wound closure.

Postoperative, follow up on D10 and D30 of patient well being and signs and symptoms of surgical site infection

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

randomized control trial, double blind
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

povidone-soaked suture

The patient is randomized, those with povidone-soaked suture group will be prepared for povidone-soaked suture during wound closure.

The absorbable suture will be soaked into povidone for 3 mins before the wound closure.

Group Type EXPERIMENTAL

povidone-soaked suture

Intervention Type OTHER

suture soak with povidone solution for 3 mins

ordinary suture

the patient is randomized, those with ordinary suture group will proceed with wound closure as usual manner following the standard practice.

Group Type ACTIVE_COMPARATOR

ordinary suture

Intervention Type OTHER

suture no need to soak with povidone solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

povidone-soaked suture

suture soak with povidone solution for 3 mins

Intervention Type OTHER

ordinary suture

suture no need to soak with povidone solution

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age more than 12 years old
* Clean surgery or Clean- contaminated surgery
* Elective surgery

Exclusion Criteria

* Age less than 12 years old
* Contaminated wound
* Dirty wound
* Allergy to povidone-iodine
* Pregnant
* Laparoscopic
* Emergency surgery
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SITI HAFZAN

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SITI HAFZAN ABD KARIM, MD

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

fz03

Identifier Type: -

Identifier Source: org_study_id