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Povidone Iodine and Cesarean Section Wound Infections

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ClinicalTrials.gov Identifier: NCT01700803
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wound Infections Drug: Povidone Iodine 10% vand cesarean section wound infections Drug: Povidone Iodine 7.5% vand cesarean section wound infections Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3231 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Povidone Iodine 10%
Using Povidone Iodine 10% hand scrub before caesarian section
 Drug: Povidone Iodine 10% vand cesarean section wound infections
Experimental: Povidone Iodine 7.5% hand scrub
Using Povidone Iodine 7.5% hand scrub before caesarian section
 Drug: Povidone Iodine 7.5% vand cesarean section wound infections


Outcome Measures
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Primary Outcome Measures :
  1. The difference of incidence of surgical site infection between both groups [ Time Frame: 4 month ]
    Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub


Secondary Outcome Measures :
  1. The difference in the side effects between both groups e.g. dermatitis [ Time Frame: 4 month ]
    Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective caesarian section (CS)

Exclusion Criteria:

  • diabetes,
  • immuno-compromised patients
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700803


Locations
Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mohammed Khairy Ali, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT01700803     History of Changes
Other Study ID Numbers: Betadine CS
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Mohammed Khairy Ali, Assiut University:
Betadine
Povidine Iodine
Hand scrubbing
Cesarean section wound infections
post cesarean section

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
 Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes