Comparison of Surgical Skin Preps During Cesarean Deliveries
Primary Purpose
Surgical Site Infection Following Cesarean Delivery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iodine povidone
Chlorhexidine
Combination iodine and chlorhexidine
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection Following Cesarean Delivery focused on measuring Cesarean delivery, Surgical site infection, Pregnancy, Postpartum
Eligibility Criteria
Inclusion Criteria:
- Gestational age > 37 weeks 0/7 days
- Non-emergency indication for cesarean
Exclusion Criteria:
- Urogenital tract infection within 2 weeks prior to surgery
- Chronic oral or injectable steroid use (> 2 weeks)
- Emergency cesarean delivery
- Participation in another research study
Sites / Locations
- Montefiore Medical Center Weiler Division
- Montefiore Medical Center Wakefield Division
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Combination iodine and chlorhexidine
Chlorhexidine
Iodine povidone
Arm Description
The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Outcomes
Primary Outcome Measures
Cesarean Surgical Site Infection
Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
Secondary Outcome Measures
Full Information
NCT ID
NCT01870583
First Posted
June 3, 2013
Last Updated
September 2, 2017
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01870583
Brief Title
Comparison of Surgical Skin Preps During Cesarean Deliveries
Official Title
Comparison of Surgical Skin Preps During Cesarean Deliveries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.
Detailed Description
Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.
The purpose of the study is:
To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)
To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.
This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.
The patients will be randomized after informed consent obtained into one of three groups: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.
Surgical preparation will follow the departmental protocol as if the patient were not in the study with exception of the skin preparation. Once the patient is randomized to the skin preparation group, the corresponding skin preparation solution will be used in accordance to manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3 (combination), the iodine based preparation will occur first followed by the chlorhexidine based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision after application of skin prep, and all patients will be surgically draped with the standard drapes as if not participating in a study. Cesarean delivery will occur following the technique of the surgeon, including skin closure method, suture or staples.
All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following delivery. Postpartum visit information will be extracted from the medical record. If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post delivery and asked about any incisional complications which may have occurred and required treatment by as physician or healthcare provider in the office or hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection Following Cesarean Delivery
Keywords
Cesarean delivery, Surgical site infection, Pregnancy, Postpartum
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination iodine and chlorhexidine
Arm Type
Active Comparator
Arm Description
The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Arm Title
Iodine povidone
Arm Type
Active Comparator
Arm Description
Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
Intervention Type
Drug
Intervention Name(s)
Iodine povidone
Intervention Description
Iodine skin preparation solution prior to cesarean delivery
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
Chlorhexidine skin preparation solution prior to cesarean delivery
Intervention Type
Drug
Intervention Name(s)
Combination iodine and chlorhexidine
Intervention Description
Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery
Primary Outcome Measure Information:
Title
Cesarean Surgical Site Infection
Description
Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.
Time Frame
42 days after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age > 37 weeks 0/7 days
Non-emergency indication for cesarean
Exclusion Criteria:
Urogenital tract infection within 2 weeks prior to surgery
Chronic oral or injectable steroid use (> 2 weeks)
Emergency cesarean delivery
Participation in another research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wallach, CIP
Organizational Affiliation
Einstein IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Montefiore Medical Center Weiler Division
City
The Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center Wakefield Division
City
The Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23622828
Citation
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Results Reference
background
PubMed Identifier
7040461
Citation
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Results Reference
background
PubMed Identifier
22000737
Citation
Stinner DJ, Krueger CA, Masini BD, Wenke JC. Time-dependent effect of chlorhexidine surgical prep. J Hosp Infect. 2011 Dec;79(4):313-6. doi: 10.1016/j.jhin.2011.08.016. Epub 2011 Oct 15.
Results Reference
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PubMed Identifier
20102279
Citation
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Results Reference
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PubMed Identifier
22353388
Citation
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Results Reference
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PubMed Identifier
15550202
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
12463081
Citation
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Results Reference
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PubMed Identifier
32580252
Citation
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26551196
Citation
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Results Reference
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Comparison of Surgical Skin Preps During Cesarean Deliveries
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