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Anti-infective

Extended Antibiotics for Preventing Infections After Cesarean Delivery (SSI Trial)

N/A

Waitlist Available

Led By Carri Warshak, MD

Research Sponsored by University of Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

age 13 or older

Delivery via cesarean section

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6weeks post partum

Awards & highlights

SSI Trial Summary

This trial will test if a longer course of antibiotics can prevent infection in obese women who have C-sections.

Who is the study for?

This trial is for English-speaking individuals aged 13 or older with a BMI over 30 who are undergoing cesarean delivery. They must consent to participate and not have any known immunodeficiency syndromes or allergies to cephalosporins or metronidazole.Check my eligibility

What is being tested?

The study is testing if taking antibiotics (cephalexin & metronidazole) for a prolonged period of 48 hours after surgery can prevent infections at the surgical site in obese patients, compared to just using a placebo.See study design

What are the potential side effects?

Possible side effects from cephalexin & metronidazole may include stomach upset, diarrhea, nausea, vomiting, rash, and rarely more serious reactions like severe allergic responses.

SSI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 13 years old or older.

Select...

I delivered my baby through a cesarean section.

SSI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6weeks post partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6weeks post partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6weeks post partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical site infection

Secondary outcome measures

Febrile morbidity; Urinary tract infection; Endometritis

SSI Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cephalexin and metronidazoleExperimental Treatment1 Intervention

500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses

Group II: Placebo/standard of carePlacebo Group1 Intervention

Placebo pills per oral every 8 hours for total of 6 doses

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

633,911 Total Patients Enrolled

Carri Warshak, MDPrincipal InvestigatorUniversity of Cincinnati

Media Library

Cephalexin & Metronidazole (Anti-infective) Clinical Trial Eligibility Overview. Trial Name: NCT01194115 — N/A

Surgical Site Infection Research Study Groups: Cephalexin and metronidazole, Placebo/standard of care

Surgical Site Infection Clinical Trial 2023: Cephalexin & Metronidazole Highlights & Side Effects. Trial Name: NCT01194115 — N/A

Cephalexin & Metronidazole (Anti-infective) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01194115 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are contributing to this research?

"This clinical trial is no longer enrolling new participants, as the most recent update to its posting occured on November 10th 2011. For those interested in other studies related to cesarean section, 803 trials are actively recruiting patients while 63 separate medical investigations into cephalexin & metronidazole are presently accepting volunteers."

Answered by AI

Are there currently any vacancies for this research trial?

"At this moment, no additional volunteers are being accepted for the trial first posted on September 1st 2010. Last edited on November 10th 2011, if you're looking to participate in other studies related to cesarean section, 803 trials are currently recruiting and 63 involving cephalexin & metronidazole actively accept patients."

Answered by AI

For which medical conditions are cephalexin and metronidazole commonly prescribed?

"Cephalexin and metronidazole are often prescribed to treat trichomonas infections, as well as dermatitis, the prevention of postoperative infections, and tetanus."

Answered by AI