Povidone Iodine and Cesarean Section Wound Infections

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Mohammed Khairy Ali, Assiut University

ClinicalTrials.gov Identifier:

NCT01700803

First received: October 3, 2012

Last updated: NA

Last verified: October 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 3, 2012
Last Updated Date	October 3, 2012
Start Date ^ICMJE	January 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 3, 2012)	The difference of incidence of surgical site infection between both groups [ Time Frame: 4 month ] [ Designated as safety issue: Yes ] Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: October 3, 2012)	The difference in the side effects between both groups e.g. dermatitis [ Time Frame: 4 month ] [ Designated as safety issue: Yes ] Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Povidone Iodine and Cesarean Section Wound Infections
Official Title ^ICMJE	Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Wound Infections
Intervention ^ICMJE	Drug: Povidone Iodine 10% vand cesarean section wound infections Drug: Povidone Iodine 7.5% vand cesarean section wound infections
Study Arm (s)	Experimental: Povidone Iodine 10% Using Povidone Iodine 10% hand scrub before caesarian section Intervention: 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 Intervention: Drug: Povidone Iodine 7.5% vand cesarean section wound infections
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3231
Completion Date	May 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: elective caesarian section (CS) Exclusion Criteria: diabetes, immuno-compromised patients
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Egypt

Administrative Information
NCT Number ^ICMJE	NCT01700803
Other Study ID Numbers ^ICMJE	Betadine CS
Has Data Monitoring Committee	Yes
Responsible Party	Mohammed Khairy Ali, Assiut University
Study Sponsor ^ICMJE	Assiut University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Assiut University
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top