STRIPES Study: Study To Reduce Infection Post cEsarean Section

NCT02402907 | Completed Results

• 1 other identifier: GCO 14-1410
• Study Type: interventional
• Target: 1,356
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis). The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.

Conditions

Chlorhexidine Gluconate Cloths; Infection; Cesarean Section; Infectious Morbidity; Surgical Site Infections; Endometritis

Keywords

cesarean section; chlorhexidine gluconate; CHG; surgical site infection; obstetrics; infection prevention; pregnancy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Incisional SSI

  Number of participants with Incisional Surgical Site Infection (SSI)

  at 6 weeks

• Number of Adherent Participants With Incisional SSI

  Among those with full adherence to the protocol and who were available for assessment at 6 weeks. Adherence to the protocol was assessed in the following 2 ways: evaluation of returned packages on the day of surgery and report ascertained by phone interview at 2 weeks.

  at 6 weeks

• Number of Participants With Endometritis

  Number of participants with endometritis

  at 6 weeks

Secondary Outcomes (4)

• Number of Participants With Maternal Complications

  up to 6 weeks

• Incidence of Neonatal ICU Admissions

  up to 6 weeks

• Maternal Length of Stay

  at 6 weeks

• Number of Participants With Maternal Readmissions

  up to 6 weeks

Study Arms (2)

CHG cloth

EXPERIMENTAL

2% chlorhexidine gluconate (CHG) cloth

Device: 2% chlorhexidine gluconate (CHG) cloth

Placebo cloth

PLACEBO COMPARATOR

A fragrance free cleansing cloth

Device: Placebo cloth

Interventions

2% chlorhexidine gluconate (CHG) cloth DEVICE

administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.

Also known as: CHG

CHG cloth

Placebo cloth DEVICE

administration of a cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.

Also known as: Cleansing cloth

Placebo cloth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women
• \> 24 weeks gestation
• scheduled for a primary or repeat cesarean section

You may not qualify if:

• allergy to chlorhexidine
• unplanned or emergency cesarean section

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Infections; Surgical Wound Infection; Endometritis

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Limitations and Caveats

Limitations included the lower than anticipated rate of SSIs after scheduled cesarean deliveries, suggesting the possibility that the study was underpowered for the primary outcome. High rate of private insurance may limit generalizability.

Results Point of Contact

• Title: Dr. Joanne Stone
• Organization: Icahn School of Medicine at Mount Sinai

joanne.stone@mssm.edu

212-241-5681

Study Officials

• Joanne Stone, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: April 1, 2015
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: November 9, 2020
• Results First Posted: November 9, 2020

Record last verified: 2020-10

Locations

US (1)