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

Not Applicable

• Conditions: Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection
• Interventions: Other: ordinary suture; Other: povidone-soaked suture

• Registration Number: NCT05090176
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

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

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 Timeline

• Study Start: 2020-11-02
• Primary Completion: 2021-05-30
• Study First Submitted: 2021-09-14
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Study Completion: 2021-11-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ordinary suture	ordinary suture	the patient is randomized, those with ordinary suture group will proceed with wound closure as usual manner following the standard practice.
povidone-soaked suture	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.

Primary Outcome Measures

Name	Time	Method
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia	6 months	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.

Trial Locations

Locations (1)

Universiti Sains Malaysia; 🇲🇾 Kubang Kerian, Kelantan, Malaysia