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

Primary Purpose

Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
povidone-soaked suture
ordinary suture
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection focused on measuring suture, povidone, surgical site infection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

povidone-soaked suture

ordinary suture

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 14, 2021
Last Updated
October 11, 2021
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05090176
Brief Title
Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
November 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection
Keywords
suture, povidone, surgical site infection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
randomized control trial, double blind
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
povidone-soaked suture
Arm Type
Experimental
Arm Description
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.
Arm Title
ordinary suture
Arm Type
Active Comparator
Arm Description
the patient is randomized, those with ordinary suture group will proceed with wound closure as usual manner following the standard practice.
Intervention Type
Other
Intervention Name(s)
povidone-soaked suture
Intervention Description
suture soak with povidone solution for 3 mins
Intervention Type
Other
Intervention Name(s)
ordinary suture
Intervention Description
suture no need to soak with povidone solution
Primary Outcome Measure Information:
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
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
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
Description
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.
Time Frame
6 months
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
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SITI HAFZAN ABD KARIM, MD
Organizational Affiliation
UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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