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Surgical Site InfectionNCT04202471

Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

A study testing Chlorhexidine Cloth in people with Surgical Site Infection, run by Northwell Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Pregnancy-associated infection represents a major cause of maternal morbidity and mortality. Cesarean delivery is the most common major surgical procedure and is associated with a rate of surgical site infection (SSI) that is approximately 5-10 times the rate for vaginal delivery. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Surgical Site Infection
What is being tested?
Chlorhexidine Cloth
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Mar 2020to 1 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

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 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • undergoing non-scheduled cesarean delivery > 23 weeks gestation

Who cannot join

  • allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Shore University Hospital

    Manhasset, New York, 11030

Other trials in United States

About this study

Official title: Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries

Pregnancy-associated infection represents a major cause of maternal morbidity and mortality. Cesarean delivery is the most common major surgical procedure and is associated with a rate of surgical site infection (SSI) that is approximately 5-10 times the rate for vaginal delivery. Efforts to reduce the risk of SSIs in this patient population include the use of preoperative antibiotic prophylaxis in addition to skin and vaginal antiseptic preparations.Nevertheless, the rate of SSI in women undergoing non-scheduled cesarean delivery is up to 18%, a significant number that contributes to prolonged hospital stays and increased health care costs.

Every effort should be made to reduce this major cause of pregnancy-associated morbidity and mortality to aid in the care of patients and reduce the associated prolonged hospital stays, readmission rates and health care costs. Studies have shown that preoperative application of chlorhexidine cloths reduces the risk of SSI, however this is based on literature in the orthopedic and intensive care patients. The efficacy of this intervention has not been studied in obstetric patients undergoing cesarean delivery. Furthermore, obstetric patients undergoing non-scheduled cesarean delivery represent a target population as it is thought that infectious morbidity is higher in this patient population. Therefore, there is a need for this trial to determine if this intervention is effective in reducing the rate of postoperative SSIs.

Read the detailed description

This randomized clinical trial will be investigating the use of preoperative chlorhexidine cloths, a chemical skin antiseptic agent effective on gram positive and gram negative bacteria, as an intervention to reduce the rate of surgical site infections (SSIs). The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths. The control group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care. The impact on women's health is significant, as a reduction in SSIs in this prevalent patient population can reduce the number of prolonged hospital stays, outpatient follow-ups for infection, hospital readmissions and health care costs.

Being tested
Chlorhexidine Cloth
Keywords
Chlorhexidine Cloth, Surgical Site Infection, Non-scheduled cesarean delivery
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorhexidine ClothDevice

    2% chlorhexidine gluconate cloth

Study groups in NCT04202471
Study groupRoleWhat they receive
Chlorhexidine ClothExperimentalThe intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths.
Receives: Device: Chlorhexidine Cloth
Standard Preoperative CareNo interventionThe no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of surgical site infection

    Measured: Up to 6 weeks after cesarean delivery

Secondary outcomes (5)

  1. Hospital length of stay

    Measured: Up to 6 weeks after cesarean delivery

  2. Number of office visits

    Measured: Up to 6 weeks after cesarean delivery

  3. Number of hospital readmissions for infection-related complications

    Measured: Up to 6 weeks after cesarean delivery

  4. Rate of endometritis

    Measured: Up to 6 weeks after cesarean delivery

  5. Rate of positive wound culture from wound

    Measured: Up to 6 weeks after cesarean delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2021 (estimated)

Why it stopped: COVID-19 pandemic

Resources

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
Double blind
Who is masked
Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202471
Sponsor's protocol ID
19-1040
Status last verified
Sep 2020
First submitted
14 Dec 2019
Last updated
24 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Carter EB, Temming LA, Fowler S, Eppes C, Gross G, Srinivas SK, Macones GA, Colditz GA, Tuuli MG. Evidence-Based Bundles and Cesarean Delivery Surgical Site Infections: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):735-746. doi: 10.1097/AOG.0000000000002249.

    PubMed 28885421

  • Shree R, Park SY, Beigi RH, Dunn SL, Krans EE. Surgical Site Infection following Cesarean Delivery: Patient, Provider, and Procedure-Specific Risk Factors. Am J Perinatol. 2016 Jan;33(2):157-64. doi: 10.1055/s-0035-1563548. Epub 2015 Sep 7.

    PubMed 26344010

  • Moulton LJ, Munoz JL, Lachiewicz M, Liu X, Goje O. Surgical site infection after cesarean delivery: incidence and risk factors at a US academic institution. J Matern Fetal Neonatal Med. 2018 Jul;31(14):1873-1880. doi: 10.1080/14767058.2017.1330882. Epub 2017 Jun 8.

    PubMed 28502188

  • Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4.

    PubMed 26844840

  • Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7.

    PubMed 28599898

  • Boyce JM. Best products for skin antisepsis. Am J Infect Control. 2019 Jun;47S:A17-A22. doi: 10.1016/j.ajic.2019.03.012.

    PubMed 31146845

  • Ahmed MR, Aref NK, Sayed Ahmed WA, Arain FR. Chlorhexidine vaginal wipes prior to elective cesarean section: does it reduce infectious morbidity? A randomized trial. J Matern Fetal Neonatal Med. 2017 Jun;30(12):1484-1487. doi: 10.1080/14767058.2016.1219996. Epub 2016 Sep 1.

    PubMed 27583685

  • Connery SA, Yankowitz J, Odibo L, Raitano O, Nikolic-Dorschel D, Louis JM. Effect of using silver nylon dressings to prevent superficial surgical site infection after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol. 2019 Jul;221(1):57.e1-57.e7. doi: 10.1016/j.ajog.2019.02.053. Epub 2019 Mar 5.

    PubMed 30849351

  • Kapadia BH, Elmallah RK, Mont MA. A Randomized, Clinical Trial of Preadmission Chlorhexidine Skin Preparation for Lower Extremity Total Joint Arthroplasty. J Arthroplasty. 2016 Dec;31(12):2856-2861. doi: 10.1016/j.arth.2016.05.043. Epub 2016 May 31.

    PubMed 27365294

  • Zywiel MG, Daley JA, Delanois RE, Naziri Q, Johnson AJ, Mont MA. Advance pre-operative chlorhexidine reduces the incidence of surgical site infections in knee arthroplasty. Int Orthop. 2011 Jul;35(7):1001-6. doi: 10.1007/s00264-010-1078-5. Epub 2010 Jun 20.

    PubMed 20563806

  • Kapadia BH, Johnson AJ, Daley JA, Issa K, Mont MA. Pre-admission cutaneous chlorhexidine preparation reduces surgical site infections in total hip arthroplasty. J Arthroplasty. 2013 Mar;28(3):490-3. doi: 10.1016/j.arth.2012.07.015. Epub 2012 Oct 29.

    PubMed 23114192

  • Dixon JM, Carver RL. Daily chlorohexidine gluconate bathing with impregnated cloths results in statistically significant reduction in central line-associated bloodstream infections. Am J Infect Control. 2010 Dec;38(10):817-21. doi: 10.1016/j.ajic.2010.06.005.

    PubMed 21093698

  • Popovich KJ, Hota B, Hayes R, Weinstein RA, Hayden MK. Effectiveness of routine patient cleansing with chlorhexidine gluconate for infection prevention in the medical intensive care unit. Infect Control Hosp Epidemiol. 2009 Oct;30(10):959-63. doi: 10.1086/605925.

    PubMed 19712033

  • Kuyyakanond T, Quesnel LB. The mechanism of action of chlorhexidine. FEMS Microbiol Lett. 1992 Dec 15;100(1-3):211-5. doi: 10.1111/j.1574-6968.1992.tb14042.x.

    PubMed 1335944

  • Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

    PubMed 20054046

Questions about this trial

What is this clinical trial studying?

A study testing Chlorhexidine Cloth in people with Surgical Site Infection, run by Northwell Health 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Sep 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. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Rate of surgical site infection (time frame: Up to 6 weeks after cesarean delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202471, which also lists 18 linked publications.

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 24 Sep 2020.

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