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

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

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- elective caesarian section (CS)
Exclusion Criteria:
- diabetes,
- immuno-compromised patients

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
Egypt | |
Women Health Hospital - Assiut university | |
Assiut, Egypt, 71111 |
Responsible Party: | Mohammed Khairy Ali, Principal Investigator, Assiut University |
ClinicalTrials.gov Identifier: | NCT01700803 |
Other Study ID Numbers: |
Betadine CS |
First Posted: | October 4, 2012 Key Record Dates |
Last Update Posted: | October 4, 2012 |
Last Verified: | October 2012 |
Betadine Povidine Iodine Hand scrubbing Cesarean section wound infections post cesarean section |
Infection Communicable Diseases Wound Infection Wounds and Injuries Iodine Cadexomer iodine Povidone-Iodine Povidone Anti-Infective Agents, Local |
Anti-Infective Agents Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Plasma Substitutes Blood Substitutes |