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Povidone Iodine and Cesarean Section Wound Infections

NCT ID: NCT01700803

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

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.

Conditions

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Wound Infections

Keywords

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Betadine Povidine Iodine Hand scrubbing Cesarean section wound infections post cesarean section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Povidone Iodine 10%

Using Povidone Iodine 10% hand scrub before caesarian section

Group Type EXPERIMENTAL

Povidone Iodine 10% vand cesarean section wound infections

Intervention Type DRUG

Povidone Iodine 7.5% hand scrub

Using Povidone Iodine 7.5% hand scrub before caesarian section

Group Type EXPERIMENTAL

Povidone Iodine 7.5% vand cesarean section wound infections

Intervention Type DRUG

Interventions

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Povidone Iodine 10% vand cesarean section wound infections

Intervention Type DRUG

Povidone Iodine 7.5% vand cesarean section wound infections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* elective caesarian section (CS)

Exclusion Criteria

* diabetes,
* immuno-compromised patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Betadine CS

Identifier Type: -

Identifier Source: org_study_id