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Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection

Primary Purpose

Surgical Site Infection

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Chlorhexidine
Povidone-Iodine
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation).
  2. Body mass index (BMI) between 20-35kg/m2.
  3. Able to communicate well with the investigator and to comply with the requirements of the entire study.

Exclusion Criteria:

  1. Rupture of membranes.
  2. Patients who have history of allergy to chlorhexidine, alcohol and iodophors.
  3. Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.

Sites / Locations

  • Ain Shams Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chlorhexidine _based antisepsis

povidone_iodine based antisepsis

Arm Description

Including cases undergoing elective&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision. .

Including cases undergoing elective&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision

Outcomes

Primary Outcome Measures

Surgical site infection within one week after surgery

Secondary Outcome Measures

Surgical site infection within 30 days after surgery
Long hospital stay
hospital admission for more than 5 days
Hospital readmission
readmission due to sepsis
Febrile morbidity
an oral temperature of 38.0 degree Celsius)or more on any two of the first 10 days postpartum, exclusive of the first 24 hours

Full Information

First Posted
March 1, 2015
Last Updated
March 23, 2015
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02396329
Brief Title
Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection
Official Title
Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.
Detailed Description
The aim of this study is to examine the efficacy &safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection.Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption. Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chlorhexidine _based antisepsis
Arm Type
Experimental
Arm Description
Including cases undergoing elective&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision. .
Arm Title
povidone_iodine based antisepsis
Arm Type
Active Comparator
Arm Description
Including cases undergoing elective&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
Betadine
Primary Outcome Measure Information:
Title
Surgical site infection within one week after surgery
Time Frame
One week
Secondary Outcome Measure Information:
Title
Surgical site infection within 30 days after surgery
Time Frame
in 30 days
Title
Long hospital stay
Description
hospital admission for more than 5 days
Time Frame
30 days
Title
Hospital readmission
Description
readmission due to sepsis
Time Frame
30 days
Title
Febrile morbidity
Description
an oral temperature of 38.0 degree Celsius)or more on any two of the first 10 days postpartum, exclusive of the first 24 hours
Time Frame
10 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation). Body mass index (BMI) between 20-35kg/m2. Able to communicate well with the investigator and to comply with the requirements of the entire study. Exclusion Criteria: Rupture of membranes. Patients who have history of allergy to chlorhexidine, alcohol and iodophors. Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMR YEHIA, MD, MRCOG
Phone
+201227900014
Email
am_helmy77@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMR YEHIA, MD, MRCOG
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AMR YEHIA, MD, MRCOG
Phone
+201227900014
Email
am_helmy77@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32580252
Citation
Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.
Results Reference
derived

Learn more about this trial

Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection

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