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

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

Detailed Description
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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

Official Title
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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

Conditions
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Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection

Intervention / Treatment
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* Other: povidone-soaked suture
* Other: ordinary suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: randomized control trial, double blind
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suture, povidone, surgical site infection