Povidone Iodine and Cesarean Section Wound Infections

Phase 3

Completed

• Conditions: Wound Infections
• Interventions: Drug: Povidone Iodine 10% vand cesarean section wound infections; Drug: Povidone Iodine 7.5% vand cesarean section wound infections

• Registration Number: NCT01700803
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Study First Posted: 2012-10-04
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3231

Inclusion Criteria

• elective caesarian section (CS)

Exclusion Criteria

• diabetes,
• immuno-compromised patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Povidone Iodine 10%	Povidone Iodine 10% vand cesarean section wound infections	Using Povidone Iodine 10% hand scrub before caesarian section
Povidone Iodine 7.5% hand scrub	Povidone Iodine 7.5% vand cesarean section wound infections	Using Povidone Iodine 7.5% hand scrub before caesarian section

Primary Outcome Measures

Name	Time	Method
The difference of incidence of surgical site infection between both groups	4 month	Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub

Secondary Outcome Measures

Name	Time	Method
The difference in the side effects between both groups e.g. dermatitis	4 month	Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt