Chlorhexidine Gluconate ClothsNCT02402907
STRIPES Study: Study To Reduce Infection Post cEsarean Section
A study testing 2% chlorhexidine gluconate (CHG) cloth in people with Chlorhexidine Gluconate Cloths and Infection; Cesarean Section, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlorhexidine Gluconate Cloths, Infection; Cesarean Section, Infectious Morbidity
- What is being tested?
- 2% chlorhexidine gluconate (CHG) cloth
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,356 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 11 Oct 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women
- > 24 weeks gestation
- scheduled for a primary or repeat cesarean section
Who cannot join
- allergy to chlorhexidine
- unplanned or emergency cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section
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.
Read the detailed description
Chlorhexidine is a sterile, germ-free solution, which is regularly used to clean the skin immediately before surgery and works by killing or preventing the growth or spread of bacteria. Data exists in both the orthopedic and cardiac literature to show that an additional preoperative use of chlorhexidine further reduces the risk of post procedure infections. Limited data exists regarding the use of a preoperative use of chlorhexidine in patients undergoing Obstetric or Gynecologic procedures and there is no wash or cloth used prior to cesarean section as a standard of care. The hope for this study is to identify if an additional preoperative chlorhexidine wash will further decrease or prevent infection in women who deliver their babies via cesarean section.
All patients with a scheduled cesarean section surgery will be approached for enrollment during their pre-admission testing visit on the labor floor 2 days before the scheduled cesarean section, a visit that is standard procedure for this surgery. Once a patient is consented, she will be randomly assigned to one of the 2 arms of the study: the eligible women will be randomized to use of 2% chlorhexidine gluconate (CHG) cloths or placebo cloths (a fragrance free cleansing cloths) on the body the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned.
The purpose of this study is to determine if the use of 2% chlorhexidine gluconate cloths prior to cesarean section reduces the rate of surgical site wound infection and/or postpartum endometritis, which is an infection or inflammation of the endometrium (the inner lining of the uterus).
- Conditions
- Chlorhexidine Gluconate Cloths, Infection; Cesarean Section, Infectious Morbidity, Surgical Site Infections, Endometritis
- Being tested
- 2% chlorhexidine gluconate (CHG) cloth, Placebo cloth
- Keywords
- cesarean section, chlorhexidine gluconate, CHG, surgical site infection, obstetrics, infection prevention, pregnancy
- Medical subject headings
- Infections, Surgical Wound Infection, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine gluconate (CHG) clothDevice
Also called CHG
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.
Placebo clothDevice
Also called Cleansing cloth
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.
| Study group | Role | What they receive |
|---|---|---|
| CHG cloth | Experimental | 2% chlorhexidine gluconate (CHG) cloth Receives: Device: 2% chlorhexidine gluconate (CHG) cloth |
| Placebo cloth | Placebo comparator | A fragrance free cleansing cloth Receives: Device: Placebo cloth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incisional SSI
Number of participants with Incisional Surgical Site Infection (SSI)
Measured: 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.
Measured: at 6 weeks
Number of Participants With Endometritis
Number of participants with endometritis
Measured: at 6 weeks
Secondary outcomes (4)
Number of Participants With Maternal Complications
Number of participants with maternal complications
Measured: up to 6 weeks
Incidence of Neonatal ICU Admissions
Measured: up to 6 weeks
Maternal Length of Stay
Length of stay (index hospitalization)
Measured: at 6 weeks
Number of Participants With Maternal Readmissions
Number of participants with hospital readmission for wound complication
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chlorhexidine Gluconate ClothsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne L Stone, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanne Stone, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402907
- Sponsor's protocol ID
- GCO 14-1410
- Status last verified
- Oct 2020
- First submitted
- 25 Mar 2015
- Last updated
- 9 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No