Povidone Iodine and Cesarean Section Wound Infections

Wound Infections Clinical Trial

Official title:

Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700803
• Other study ID #: Betadine CS
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2012
• Last updated: October 3, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3231
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• elective caesarian section (CS)

Exclusion Criteria:

• diabetes,

• immuno-compromised patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Wound Infection
• Wound Infections

Intervention

Drug:
• Povidone Iodine 10% vand cesarean section wound infections

• Povidone Iodine 7.5% vand cesarean section wound infections

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of incidence of surgical site infection between both groups	Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub	4 month	Yes
Secondary	The difference in the side effects between both groups e.g. dermatitis	Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub	4 month	Yes