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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
  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:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

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
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
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

No publications provided

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:
Wound Infection
Infection
Wounds and Injuries
Povidone
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013