Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections

Sponsor

University of Pittsburgh (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05920122

Collaborator

(none)

1,470

Enrollment

Location

Arms

Anticipated Duration (Months)

133.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Cesarean Section; Infection	Drug: 2% Chlorhexidine gluconate with 70% alcohol Drug: 4% Chlorhexidine Gluconate aqueous solution	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1470 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 : 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 membranesImmediately 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:

Single (Outcomes Assessor)

Masking Description:

The provider making the diagnosis of wound infection will be blinded to the intervention

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep) 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)	Drug: 2% Chlorhexidine gluconate with 70% alcohol 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) Other Names: ChloraPrep
Experimental: 4% chlorhexidine gluconate (Hibiclens) 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.	Drug: 4% Chlorhexidine Gluconate aqueous solution 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. Other Names: Hibiclens

Arm

Intervention/Treatment

Experimental: 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)

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)

Drug: 2% Chlorhexidine gluconate with 70% alcohol

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)

Other Names:

ChloraPrep

Experimental: 4% chlorhexidine gluconate (Hibiclens)

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.

Drug: 4% Chlorhexidine Gluconate aqueous solution

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.

Other Names:

Hibiclens

Outcome Measures

Primary Outcome Measures

Number of Participants with Surgical site Infection [Within 30 days post cesarean]
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 [Within 30 days post cesarean]
Number of Participants with intrabdominal/pelvic abscess [Within 30 days post cesarean]
Number of Participants with necrotizing fasciitis [Within 30 days post cesarean]
Number of Participants with sepsis [Within 30 days post cesarean]
With wound/uterine infection as the source
Length of Hospital Stay [Within 30 days post cesarean]
Number of Participants With Re-admissions or Office Visits for Wound-related Problems [Within 30 days post cesarean]
Number of Participants with ICU admission for wound infectious complications [Within 30 days post cesarean]
Number of Participants with Need for wound opening, exploration, or washout in the operating room [Within 30 days post cesarean]
Number of Participants who needed wound vacuum [Within 30 days post cesarean]
Number of Participants who needed home health [Within 30 days post cesarean]
Number of patients who needed antibiotics [Within 30 days post cesarean]
will also collect route of antibiotic administration and duration of treatment to assist with cost analysis
Number of doses of antibiotic treatment [Within 30 days post cesarean]
for wound infection complications
Antibiotic regimens (medication names) used to treat infection [Within 30 days post cesarean]
for wound infection complications
Number of participants with positive culture from wound [Within 30 days post cesarean]
The type of bacterial species isolated from wound infection cultures [Within 30 days post cesarean]
Number of participants with hematoma [Within 30 days post cesarean]
Number of participants with seroma [Within 30 days post cesarean]
Number of Participants With Skin Irritation [within 48 hours from delivery]
Number of Participants With Allergic Reaction [within 48 hours from delivery]
Cost Savings [Within 30 days post cesarean]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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