Povidone Iodine and Cesarean Section Wound Infections

Assiut University

Status and phase: Completed; Phase 3

Conditions: Wound Infections

Treatments: Drug: Povidone Iodine 7.5% vand cesarean section wound infections; Drug: Povidone Iodine 10% vand cesarean section wound infections

Study type: Interventional

Funder types: Other

Identifiers

NCT01700803

Betadine CS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,231 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective caesarian section (CS)

Exclusion criteria

• diabetes,
• immuno-compromised patients

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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3,231 participants in 2 patient groups

Povidone Iodine 10%

Experimental group

Description:

Using Povidone Iodine 10% hand scrub before caesarian section

Treatment:

Drug: Povidone Iodine 10% vand cesarean section wound infections

Povidone Iodine 7.5% hand scrub

Experimental group

Description:

Using Povidone Iodine 7.5% hand scrub before caesarian section

Treatment:

Drug: Povidone Iodine 7.5% vand cesarean section wound infections