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Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

Primary Purpose

Surgical Site Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine Cloth
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Chlorhexidine Cloth, Surgical Site Infection, Non-scheduled cesarean delivery

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • undergoing non-scheduled cesarean delivery > 23 weeks gestation

Exclusion Criteria:

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

Sites / Locations

  • North Shore University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chlorhexidine Cloth

Standard Preoperative Care

Arm Description

The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths.

The no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care.

Outcomes

Primary Outcome Measures

Rate of surgical site infection

Secondary Outcome Measures

Hospital length of stay
Number of office visits
Number of hospital readmissions for infection-related complications
Rate of endometritis
Rate of positive wound culture from wound

Full Information

First Posted
December 14, 2019
Last Updated
September 22, 2020
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04202471
Brief Title
Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries
Official Title
Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 pandemic
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Chlorhexidine Cloth, Surgical Site Infection, Non-scheduled cesarean delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine Cloth
Arm Type
Experimental
Arm Description
The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths.
Arm Title
Standard Preoperative Care
Arm Type
No Intervention
Arm Description
The no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care.
Intervention Type
Device
Intervention Name(s)
Chlorhexidine Cloth
Intervention Description
2% chlorhexidine gluconate cloth
Primary Outcome Measure Information:
Title
Rate of surgical site infection
Time Frame
Up to 6 weeks after cesarean delivery
Secondary Outcome Measure Information:
Title
Hospital length of stay
Time Frame
Up to 6 weeks after cesarean delivery
Title
Number of office visits
Time Frame
Up to 6 weeks after cesarean delivery
Title
Number of hospital readmissions for infection-related complications
Time Frame
Up to 6 weeks after cesarean delivery
Title
Rate of endometritis
Time Frame
Up to 6 weeks after cesarean delivery
Title
Rate of positive wound culture from wound
Time Frame
Up to 6 weeks after cesarean delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: undergoing non-scheduled cesarean delivery > 23 weeks gestation Exclusion Criteria: allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28885421
Citation
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.
Results Reference
background
PubMed Identifier
26344010
Citation
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.
Results Reference
background
PubMed Identifier
28502188
Citation
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.
Results Reference
background
PubMed Identifier
26844840
Citation
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.
Results Reference
background
PubMed Identifier
28599898
Citation
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.
Results Reference
background
PubMed Identifier
31146845
Citation
Boyce JM. Best products for skin antisepsis. Am J Infect Control. 2019 Jun;47S:A17-A22. doi: 10.1016/j.ajic.2019.03.012.
Results Reference
background
PubMed Identifier
27583685
Citation
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.
Results Reference
background
PubMed Identifier
30849351
Citation
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.
Results Reference
background
PubMed Identifier
27365294
Citation
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.
Results Reference
background
PubMed Identifier
20563806
Citation
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.
Results Reference
background
PubMed Identifier
23114192
Citation
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.
Results Reference
background
PubMed Identifier
21093698
Citation
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.
Results Reference
background
PubMed Identifier
19712033
Citation
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.
Results Reference
background
PubMed Identifier
1335944
Citation
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.
Results Reference
background
PubMed Identifier
20054046
Citation
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.
Results Reference
background
PubMed Identifier
18489920
Citation
DeBaun B. Evaluation of the antimicrobial properties of an alcohol-free 2% chlorhexidine gluconate solution. AORN J. 2008 May;87(5):925-33. doi: 10.1016/j.aorn.2008.02.001.
Results Reference
background
PubMed Identifier
18656052
Citation
Edmiston CE Jr, Krepel CJ, Seabrook GR, Lewis BD, Brown KR, Towne JB. Preoperative shower revisited: can high topical antiseptic levels be achieved on the skin surface before surgical admission? J Am Coll Surg. 2008 Aug;207(2):233-9. doi: 10.1016/j.jamcollsurg.2007.12.054. Epub 2008 May 23.
Results Reference
background
PubMed Identifier
17327187
Citation
Edmiston CE Jr, Seabrook GR, Johnson CP, Paulson DS, Beausoleil CM. Comparative of a new and innovative 2% chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery. Am J Infect Control. 2007 Mar;35(2):89-96. doi: 10.1016/j.ajic.2006.06.012.
Results Reference
background

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Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

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