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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

October 3, 2012
October 3, 2012
January 2012
April 2012   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
Povidone Iodine and Cesarean Section Wound Infections
Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Wound Infections
  • Drug: Povidone Iodine 10% vand cesarean section wound infections
  • Drug: Povidone Iodine 7.5% vand cesarean section wound infections
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3231
May 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • elective caesarian section (CS)

Exclusion Criteria:

  • diabetes,
  • immuno-compromised patients
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01700803
Betadine CS
Yes
Mohammed Khairy Ali, Assiut University
Assiut University
Not Provided
Not Provided
Assiut University
October 2012

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