Prophylactic Antibiotics After Cesarean (PAC)

• ClinicalTrials.gov Identifier: NCT03187106
• Recruitment Status: Recruiting
• First Posted: June 14, 2017
• Last Update Posted: February 15, 2019
• Sponsor: The University of Texas Medical Branch, Galveston
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

Brief Summary:

The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring.

Condition or disease	Intervention/treatment	Phase
Surgical Site Infection	Drug: Cephalexin; Drug: Placebo; Drug: Metronidazole	Phase 1

Detailed Description:

The investigators propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection in women who are obese and have been laboring prior to their Cesarean section. This study is to be conducted by the Department of Obstetrics & Gynecology at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. The intervention being studied will be the administration of cephalexin and metronidazole post-operatively for 48 hours. The primary outcome measure will be surgical site infection (including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess) in the post-operative period.

In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA-filtered and positive air-pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery, as well as general OR traffic, will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An adhesive drape will be used. Prior to skin incision, cefazolin and azithromycin will be administered.

All patients to be considered for recruitment to this study will be undergoing delivery at John Sealy Hospital at the University of Texas Medical Branch in Galveston, Texas. Patients with an elevated BMI >or =30 kg/m2 who undergo cesarean section after laboring will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blinded
• Primary Purpose: Treatment
• Official Title: Prophylactic Antibiotics After Cesarean
• Actual Study Start Date: August 1, 2017
• Estimated Primary Completion Date: June 5, 2020
• Estimated Study Completion Date: June 5, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cephalexin and metronidazole; 500 mg cephalexin per oral every 8 hours for a total of 6 doses; 500 mg metronidazole per oral every 8 hours for a total of 6 doses	Drug: Cephalexin; Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses; Drug: Metronidazole; Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses
Placebo Comparator: Placebo / standard of care; Placebo pills per oral every 8 hours for a total of 6 doses	Drug: Placebo; Placebo representing standard of care

Outcome Measures

Primary Outcome Measures :

1. Surgical site infection [ Time Frame: 6 weeks postpartum ]
   Including superficial or deep incisional surgical site infection, endometritis, and other related infections, such as septic pelvic thrombophlebitis and abdominal or pelvic abscess

Secondary Outcome Measures :

1. Maternal mortality [ Time Frame: 6 weeks (42 days) postpartum ]
   Maternal death
2. Febrile morbidity [ Time Frame: 6 weeks (42 days) postpartum ]
   If the patient develops a measured temperate greater than or equal to 100.4 degrees Fahrenheit (or 38.0 degrees Celsius), she will have a postpartum fever.
3. Postpartum antibiotic use [ Time Frame: 6 weeks (42 days) postpartum ]
   We will assess via chart review and direct patient inquiry whether or not antibiotics were taken by the patient for any purpose during the six weeks (42 days) immediately following delivery.
4. Wound hematoma or seroma [ Time Frame: 6 weeks (42 days) postpartum ]
   Wound hematoma or seroma, as diagnosed by a medical provider, according to CDC guidelines for diagnosis of wound hematoma or seroma
5. Use of resources [ Time Frame: 6 weeks (42 days) postpartum ]
   We will note whether the patient required hospital re-admission, emergency department visits, or need for imaging or other invasive procedures
6. Other adverse events [ Time Frame: 6 weeks postpartum ]
   Such as allergic reaction to study medications

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Women >18 and <50 years
• BMI >30kg/m2
• Decision by clinical team to perform Cesarean section
• Rupture of membranes (ROM) < 24 hours after onset of labor or during the course of labor (ROM defined by spontaneous or artificial rupture of the amniotic sac)

Exclusion Criteria:

• Subject unwilling or unable to provide consent
• No prenatal care or a non-UTMB subject who is unlikely to be followed up after delivery
• Fetal demise or major congenital anomaly
• Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other
• Diagnosis or suspicion of chorioamnionitis prior to randomization
• Other planned post-operative antibiotic administration
• High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery)
• Known allergy or contraindication to cephalosporins or metronidazole
• Incarcerated individuals

Contacts and Locations

Contacts

Contact: Maggie J Kuhlmann-Capek, MD; 4097897784; makuhlma@utmb.edu

Contact: Antonio F Saad, MD; 4097721571; afsaad@utmb.edu

Locations

United States, Texas

St. David's North Austin Medical Center; Recruiting

Austin, Texas, United States, 78758

Contact: Richard T Hale, PhD

University of Texas Medical Branch John Sealy Hospital; Recruiting

Galveston, Texas, United States, 77555

Contact: Maggie J Kuhlmann-Capek, MD 409-789-7784 makuhlma@utmb.edu

Contact: Antonio F Saad, MD 4097721571 afsaad@utmb.edu

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

• Principal Investigator: Antonio F Saad, MD; University of Texas

More Information

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03187106 History of Changes
• Other Study ID Numbers: 17-0035
• First Posted: June 14, 2017
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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.: Yes

Additional relevant MeSH terms:

Surgical Wound Infection; Wound Infection; Infection; Postoperative Complications; Pathologic Processes; Anti-Bacterial Agents; Metronidazole; Cephalexin; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents