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

Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia

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

Study Overview

• Status: Active, not recruiting
• Conditions: Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection
• Intervention / Treatment: Other: povidone-soaked suture; Other: ordinary suture

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: povidone-soaked suture; suture soak with povidone solution for 3 mins
Active Comparator: ordinary suture; the patient is randomized, those with ordinary suture group will proceed with wound closure as usual manner following the standard practice.	Other: ordinary suture; suture no need to soak with povidone solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia	There is difference of outcome using povidone-soaked suture and ordinary suture. In this study, our hypothesis the suture with povidone-soaked will reduce the SSIs rate during closure and it will be assessed on day 10 and day 30 post-operative. Few measurement are used in detection of SSI based on clinical and biochemical measurement such as signs of inflammation and total white cell count.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia	There is association between povidone-soaked suture and ordinary suture in reducing surgical site infection. There is difference of outcome using povidone-soaked suture and ordinary suture. In this study, our hypothesis the suture with povidone-soaked will reduce the SSIs rate during closure and it will be assessed on day 10 and day 30 post-operative. Few measurement are used in detection of SSI based on clinical and biochemical measurement such as signs of inflammation and total white cell count.	6 months
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia	There is difference in the extent of intervention needed to manage SSIs in wounds closed with povidone-soaked suture and ordinary suture. This hypothesis measure how far that the management of SSIs whether non-operative or operative treatment is needed. This is base on antibiotic use, dressing and surgical intervention such as debridement.	6 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: SITI HAFZAN ABD KARIM, MD, UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Anticipated): November 2, 2021

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: surgical site infection; suture; povidone
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Plasma Substitutes; Blood Substitutes; Povidone
• Other Study ID Numbers: fz03

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