Povidone Iodine and Cesarean Section Wound Infections
This study has been completed.
Sponsor:
Assiut University
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Wound Infections |
Drug: Povidone Iodine 10% vand cesarean section wound infections Drug: Povidone Iodine 7.5% vand cesarean section wound infections |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Assiut University:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 3231 |
| Study Start Date: | January 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Genders 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700803
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700803
Locations
| Egypt | |
| Women Health Hospital - Assiut university | |
| Assiut, Egypt, 71111 | |
Sponsors and Collaborators
Assiut University
More Information
| Responsible Party: | Mohammed Khairy Ali, Principal Investigator, Assiut University |
| ClinicalTrials.gov Identifier: | NCT01700803 History of Changes |
| Other Study ID Numbers: | Betadine CS |
| Study First Received: | October 3, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | Egypt: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 28, 2016