Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

NCT04202471 | Withdrawn FDA Device

• 1 other identifier: 19-1040
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Chlorhexidine Cloth; Surgical Site Infection; Non-scheduled cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Rate of surgical site infection

  Up to 6 weeks after cesarean delivery

Secondary Outcomes (5)

• Hospital length of stay

  Up to 6 weeks after cesarean delivery

• Number of office visits

  Up to 6 weeks after cesarean delivery

• Number of hospital readmissions for infection-related complications

  Up to 6 weeks after cesarean delivery

• Rate of endometritis

  Up to 6 weeks after cesarean delivery

• Rate of positive wound culture from wound

  Up to 6 weeks after cesarean delivery

Study Arms (2)

Chlorhexidine Cloth

EXPERIMENTAL

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

Device: Chlorhexidine Cloth

Standard Preoperative Care

NO INTERVENTION

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

Interventions

Chlorhexidine Cloth DEVICE

2% chlorhexidine gluconate cloth

Chlorhexidine Cloth

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• undergoing non-scheduled cesarean delivery \> 23 weeks gestation

You may not qualify if:

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (18)

• 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.

  PMID: 28885421 BACKGROUND

• 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.

  PMID: 26344010 BACKGROUND

• 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.

  PMID: 28502188 BACKGROUND

• 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.

  PMID: 26844840 BACKGROUND

• 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.

  PMID: 28599898 BACKGROUND

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

  PMID: 31146845 BACKGROUND

• 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.

  PMID: 27583685 BACKGROUND

• 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.

  PMID: 30849351 BACKGROUND

• 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.

  PMID: 27365294 BACKGROUND

• 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.

  PMID: 20563806 BACKGROUND

• 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.

  PMID: 23114192 BACKGROUND

• 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.

  PMID: 21093698 BACKGROUND

• 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.

  PMID: 19712033 BACKGROUND

• 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.

  PMID: 1335944 BACKGROUND

• 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.

  PMID: 20054046 BACKGROUND

• 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.

  PMID: 18489920 BACKGROUND

• 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.

  PMID: 18656052 BACKGROUND

• 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.

  PMID: 17327187 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 17, 2019
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

US (1)