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Povidone Iodine and Cesarean Section Wound Infections

Primary Purpose

Wound Infections

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Povidone Iodine 10% vand cesarean section wound infections

Povidone Iodine 7.5% vand cesarean section wound infections

About this trial

This is an interventional prevention trial for Wound Infections focused on measuring Betadine, Povidine Iodine, Hand scrubbing, Cesarean section wound infections, post cesarean section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

elective caesarian section (CS)

Exclusion Criteria:

diabetes,
immuno-compromised patients

Sites / Locations

Women Health Hospital - Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Povidone Iodine 10%

Povidone Iodine 7.5% hand scrub

Arm Description

Using Povidone Iodine 10% hand scrub before caesarian section

Using Povidone Iodine 7.5% hand scrub before caesarian section

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01700803

First Posted

October 3, 2012

Last Updated

October 3, 2012

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT01700803

Brief Title

Povidone Iodine and Cesarean Section Wound Infections

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Infections

Keywords

Betadine, Povidine Iodine, Hand scrubbing, Cesarean section wound infections, post cesarean section

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

3231 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Povidone Iodine 10%

Arm Type

Experimental

Arm Description

Using Povidone Iodine 10% hand scrub before caesarian section

Arm Title

Povidone Iodine 7.5% hand scrub

Arm Type

Experimental

Arm Description

Using Povidone Iodine 7.5% hand scrub before caesarian section

Intervention Type

Drug

Intervention Name(s)

Povidone Iodine 10% vand cesarean section wound infections

Intervention Type

Drug

Intervention Name(s)

Povidone Iodine 7.5% vand cesarean section wound infections

Primary Outcome Measure Information:

Title

The difference of incidence of surgical site infection between both groups

Description

Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub

Time Frame

4 month

Secondary Outcome Measure Information:

Title

The difference in the side effects between both groups e.g. dermatitis

Description

Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub

Time Frame

4 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: elective caesarian section (CS) Exclusion Criteria: diabetes, immuno-compromised patients

Facility Information:

Facility Name

Women Health Hospital - Assiut university

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

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Povidone Iodine and Cesarean Section Wound Infections

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