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

• Sponsor: Universiti Sains Malaysia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05090176
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 11.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection	Other: povidone-soaked suture; Other: ordinary suture	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: randomized control trial, double blindrandomized control trial, double blind
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Nov 2, 2020
• Actual Primary Completion Date: May 30, 2021
• Anticipated Study Completion Date: Nov 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universiti Sains Malaysia	Kubang Kerian	Kelantan	Malaysia	16150

Sponsors and Collaborators

• Universiti Sains Malaysia

Investigators

• Principal Investigator: SITI HAFZAN ABD KARIM, MD, UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SITI HAFZAN, Principle investigator, Universiti Sains Malaysia
• ClinicalTrials.gov Identifier: NCT05090176
• Other Study ID Numbers: fz03
• First Posted: Oct 22, 2021
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SITI HAFZAN, Principle investigator, Universiti Sains Malaysia: suture; povidone; surgical site infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Povidone

Study Results

No Results Posted as of Oct 22, 2021