Back to resultsAqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections
Primary Purpose
Surgical Site Infection, Cesarean Section; Infection
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
2% Chlorhexidine gluconate with 70% alcohol
4% Chlorhexidine Gluconate aqueous solution
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria: Women undergoing cesarean delivery at Magee Women's Hospital Exclusion Criteria: Inability to obtain consent (language barrier, emergency cesarean section etc.) Allergy to chlorhexidine or alcohol Chorioamnionitis Emergency cesareans where cannot wait for chlorhexidine alcohol to dry bowel injury at time of cesarean section Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital
Sites / Locations
- University of PittsburghRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)
4% chlorhexidine gluconate (Hibiclens)
Arm Description
Including cases undergoing elective &non elective caesarean section. Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min)
Including cases undergoing elective & nonelective caesarean section. Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.
Outcomes
Primary Outcome Measures
Number of Participants with Surgical site Infection
Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
Secondary Outcome Measures
Number of Participants With Endometritis
Number of Participants with intrabdominal/pelvic abscess
Number of Participants with necrotizing fasciitis
Number of Participants with sepsis
With wound/uterine infection as the source
Length of Hospital Stay
Number of Participants With Re-admissions or Office Visits for Wound-related Problems
Number of Participants with ICU admission for wound infectious complications
Number of Participants with Need for wound opening, exploration, or washout in the operating room
Number of Participants who needed wound vacuum
Number of Participants who needed home health
Number of patients who needed antibiotics
will also collect route of antibiotic administration and duration of treatment to assist with cost analysis
Number of doses of antibiotic treatment
for wound infection complications
Antibiotic regimens (medication names) used to treat infection
for wound infection complications
Number of participants with positive culture from wound
The type of bacterial species isolated from wound infection cultures
Number of participants with hematoma
Number of participants with seroma
Number of Participants With Skin Irritation
Number of Participants With Allergic Reaction
Cost Savings
costs (dollars) associated with a hospital stay, office visits and re-admissions for infection-related complications, ICU admission for infectious complications, wound exploration or washout in the operating room, wound vacuum use, home health, antibiotic prescriptions, and duration of treatment will be collected and used to calculate the cost of wound infection management. The cost difference between groups will be calculated to estimate cost savings.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05920122
Brief Title
Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections
Official Title
A Randomized Control Trial of Chlorhexidine Gluconate Aqueous Solution vs Chlorhexidine Gluconate With Isopropyl Alcohol Skin Preparations for Prevention of Cesarean Section Wound Infections
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yaneve Fonge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Cesarean Section; Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Immediately prior to entering the operating room, participants will be randomly assigned in a 1:1 ratio to the CHG or CHG-IPA group. Groups will be stratified by laboring status defined as :
Regular contractions with cervical dilation of 4 cm or more OR
Documented cervical change of at least 1 cm of dilation or at least 50% effacement OR
Rupture of membranes
Masking
Outcomes Assessor
Masking Description
The provider making the diagnosis of wound infection will be blinded to the intervention
Allocation
Randomized
Enrollment
1470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)
Arm Type
Experimental
Arm Description
Including cases undergoing elective &non elective caesarean section. Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min)
Arm Title
4% chlorhexidine gluconate (Hibiclens)
Arm Type
Experimental
Arm Description
Including cases undergoing elective & nonelective caesarean section. Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.
Intervention Type
Drug
Intervention Name(s)
2% Chlorhexidine gluconate with 70% alcohol
Other Intervention Name(s)
ChloraPrep
Intervention Description
Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min)
Intervention Type
Drug
Intervention Name(s)
4% Chlorhexidine Gluconate aqueous solution
Other Intervention Name(s)
Hibiclens
Intervention Description
Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.
Primary Outcome Measure Information:
Title
Number of Participants with Surgical site Infection
Description
Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
Time Frame
Within 30 days post cesarean
Secondary Outcome Measure Information:
Title
Number of Participants With Endometritis
Time Frame
Within 30 days post cesarean
Title
Number of Participants with intrabdominal/pelvic abscess
Time Frame
Within 90 days post cesarean
Title
Number of Participants with necrotizing fasciitis
Time Frame
Within 90 days post cesarean
Title
Number of Participants with sepsis
Description
With wound/uterine infection as the source
Time Frame
Within 90 days post cesarean
Title
Length of Hospital Stay
Time Frame
Within 90 days post cesarean
Title
Number of Participants With Re-admissions or Office Visits for Wound-related Problems
Time Frame
Within 90 days post cesarean
Title
Number of Participants with ICU admission for wound infectious complications
Time Frame
Within 90 days post cesarean
Title
Number of Participants with Need for wound opening, exploration, or washout in the operating room
Time Frame
Within 90 days post cesarean
Title
Number of Participants who needed wound vacuum
Time Frame
Within 90 days post cesarean
Title
Number of Participants who needed home health
Time Frame
Within 90 days post cesarean
Title
Number of patients who needed antibiotics
Description
will also collect route of antibiotic administration and duration of treatment to assist with cost analysis
Time Frame
Within 90 days post cesarean
Title
Number of doses of antibiotic treatment
Description
for wound infection complications
Time Frame
Within 90 days post cesarean
Title
Antibiotic regimens (medication names) used to treat infection
Description
for wound infection complications
Time Frame
Within 90 days post cesarean
Title
Number of participants with positive culture from wound
Time Frame
Within 90 days post cesarean
Title
The type of bacterial species isolated from wound infection cultures
Time Frame
Within 90 days post cesarean
Title
Number of participants with hematoma
Time Frame
Within 90 days post cesarean
Title
Number of participants with seroma
Time Frame
Within 30 days post cesarean
Title
Number of Participants With Skin Irritation
Time Frame
within 48 hours from delivery
Title
Number of Participants With Allergic Reaction
Time Frame
within 48 hours from delivery
Title
Cost Savings
Description
costs (dollars) associated with a hospital stay, office visits and re-admissions for infection-related complications, ICU admission for infectious complications, wound exploration or washout in the operating room, wound vacuum use, home health, antibiotic prescriptions, and duration of treatment will be collected and used to calculate the cost of wound infection management. The cost difference between groups will be calculated to estimate cost savings.
Time Frame
Within 90 days post cesarean
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women undergoing cesarean delivery at Magee Women's Hospital
Exclusion Criteria:
Inability to obtain consent (language barrier, emergency cesarean section etc.)
Allergy to chlorhexidine or alcohol
Chorioamnionitis
Emergency cesareans where cannot wait for chlorhexidine alcohol to dry
bowel injury at time of cesarean section
Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaneve Fonge, MD
Phone
412-641-6331
Email
Fongeyn@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Bennett, MD
Email
bennettcd2@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaneve Fonge, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaneve N Fonge
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Links:
URL
https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm
Description
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Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections
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