Clinical trial NCT05920122: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Cesarean Section; Infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 1470
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 :

1. Regular contractions with cervical dilation of 4 cm or more OR
2. Documented cervical change of at least 1 cm of dilation or at least 50% effacement OR
3. Rupture of membranes
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants with Surgical site Infection
timeFrame: Within 30 days post cesarean
Secondary outcomes:
measure: Number of Participants With Endometritis
timeFrame: Within 30 days post cesarean
measure: Number of Participants with intrabdominal/pelvic abscess
timeFrame: Within 90 days post cesarean
measure: Number of Participants with necrotizing fasciitis
timeFrame: Within 90 days post cesarean
measure: Number of Participants with sepsis
timeFrame: Within 90 days post cesarean
measure: Length of Hospital Stay
timeFrame: Within 90 days post cesarean
measure: Number of Participants With Re-admissions or Office Visits for Wound-related Problems
timeFrame: Within 90 days post cesarean
measure: Number of Participants with ICU admission for wound infectious complications
timeFrame: Within 90 days post cesarean
measure: Number of Participants with Need for wound opening, exploration, or washout in the operating room
timeFrame: Within 90 days post cesarean
measure: Number of Participants who needed wound vacuum
timeFrame: Within 90 days post cesarean
measure: Number of Participants who needed home health
timeFrame: Within 90 days post cesarean
measure: Number of patients who needed antibiotics
timeFrame: Within 90 days post cesarean
measure: Number of doses of antibiotic treatment
timeFrame: Within 90 days post cesarean
measure: Antibiotic regimens (medication names) used to treat infection
timeFrame: Within 90 days post cesarean
measure: Number of participants with positive culture from wound
timeFrame: Within 90 days post cesarean
measure: The type of bacterial species isolated from wound infection cultures
timeFrame: Within 90 days post cesarean
measure: Number of participants with hematoma
timeFrame: Within 90 days post cesarean
measure: Number of participants with seroma
timeFrame: Within 30 days post cesarean
measure: Number of Participants With Skin Irritation
timeFrame: within 48 hours from delivery
measure: Number of Participants With Allergic Reaction
timeFrame: within 48 hours from delivery
measure: Cost Savings
timeFrame: Within 90 days post cesarean
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yaneve Fonge, MD
role: PRINCIPAL_INVESTIGATOR
References:
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