Povidone Iodine and Cesarean Section Wound Infections

Study Overview
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Brief Summary
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The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections & compare side effects of both agents.

Detailed Description
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For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings. There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol & triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect & fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk & proven its efficiency.

Official Title
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Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial

Conditions
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Wound Infections

Intervention / Treatment
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* Drug: Povidone Iodine 10% vand cesarean section wound infections
* Drug: Povidone Iodine 7.5% vand cesarean section wound infections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective caesarian section (CS) Exclusion Criteria: diabetes, immuno-compromised patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone Iodine 10%<br>Using Povidone Iodine 10% hand scrub before caesarian section | Drug: Povidone Iodine 10% vand cesarean section wound infections<br> <br> |
| Experimental: Povidone Iodine 7.5% hand scrub<br>Using Povidone Iodine 7.5% hand scrub before caesarian section | Drug: Povidone Iodine 7.5% vand cesarean section wound infections<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of incidence of surgical site infection between both groups | Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the side effects between both groups e.g. dermatitis | Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Povidine Iodine, Betadine, Hand scrubbing, Cesarean section wound infections, post cesarean section