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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT02402907
- Acronym / sponsor ID
- GCO 14-1410
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,356 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 9 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHG cloth | Experimental | Device: 2% chlorhexidine gluconate (CHG) cloth2% chlorhexidine gluconate (CHG) cloth |
| Placebo cloth | Placebo comparator | Device: Placebo clothA fragrance free cleansing cloth |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women
- > 24 weeks gestation
- scheduled for a primary or repeat cesarean section
Key exclusion criteria (2 listed)
- allergy to chlorhexidine
- unplanned or emergency cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% chlorhexidine gluconate (CHG) clothAlso: CHGadministration 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. | Device | CHG cloth |
| Placebo clothAlso: Cleansing clothadministration 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. | Device | Placebo cloth |
Primary outcome
Number of Participants With Incisional SSI
Time frame: at 6 weeks
Number of participants with Incisional Surgical Site Infection (SSI)
Number of Adherent Participants With Incisional SSI
Time frame: at 6 weeks
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.
Number of Participants With Endometritis
Time frame: at 6 weeks
Number of participants with endometritis
4 secondary outcomes
Number of Participants With Maternal Complications
Time frame: up to 6 weeks
Incidence of Neonatal ICU Admissions
Time frame: up to 6 weeks
Maternal Length of Stay
Time frame: at 6 weeks
Number of Participants With Maternal Readmissions
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Stone, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Incisional SSI (time frame: at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.