Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Povidone Iodine and Cesarean Section Wound Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 4, 2012
Last Update Posted Date October 4, 2012
Study Start Date  ICMJE January 2012
Actual 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 ]
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 ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: October 3, 2012)
3231
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01700803
Other Study ID Numbers  ICMJE Betadine CS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohammed Khairy Ali, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP