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NCT Number: NCT01700803

Povidone Iodine and Cesarean Section Wound Infections

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.

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Key information

Conditions

Wound Infections Infections Wound Infection

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective caesarian section (CS)

Exclusion criteria

  • diabetes,
  • immuno-compromised patients

Treatment and study plan

Povidone Iodine 10% vand cesarean section wound infections

Drug

Povidone Iodine 7.5% vand cesarean section wound infections

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2012
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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