Comparison of Surgical Skin Preps During Cesarean Deliveries

Surgical Site Infection Following Cesarean Delivery Clinical Trial

Official title:

Comparison of Surgical Skin Preps During Cesarean Deliveries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870583
• Other study ID #: CCI#12-07-248
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: September 2, 2017
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2017
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.

Description:

Currently the skin preparation solutions currently in use for cesarean delivery are chlorhexidine-alcohol based solutions or iodine povidone solutions There had been no recommendations of which surgical skin prep wound be best utilized for cesarean delivery, especially if the patient has risk factors for surgical site infection. Chlorhexidine solution has been reported to take minimal of 2 minutes after application to decrease the bacterial load, and continue to decrease the bacteria load up to 1 hour. Iodine povidone solution has been reported to be completely effective within 4 minutes of application. Patient's risk factor for surgical site infection, including obesity, history of incision complications, maternal diabetes, chorioamnionitis, potentially influence which surgical skin prep to be applied. Finally, the majority of postpartum infections manifest after hospital discharge and most of these post-discharge infections are diagnosed and treated entirely in the ambulatory setting, without the patients' returning to the hospital.

The purpose of the study is:

1. To compare chlorhexidine based solution, iodine povidone solution, and combination of both agents in cesarean delivery skin preparation solution for prevention of surgical site infection (SSI)

2. To determine if surgical site infection (SSI) risk factors should guide selection of one specific surgical skin preparation solution.

This will be a prospective randomized observational study of the women presenting for care to the Montefiore Medical Center. All patients will undergo routine obstetrical care and preparation for cesarean delivery as if they were not participating in this research study. All patients in the study will receive the pre-operative intravenous antibiotics pre-operatively as part of departmental protocol for cesarean delivery.

The patients will be randomized after informed consent obtained into one of three groups:

Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Sequentially numbered envelopes will contain the group of randomization for the patient created by a computer generated program which will occur prior to commencement of the study.

Surgical preparation will follow the departmental protocol as if the patient were not in the study with exception of the skin preparation. Once the patient is randomized to the skin preparation group, the corresponding skin preparation solution will be used in accordance to manufacturer's guidelines for the product and Departmental protocol. If randomized to group 3 (combination), the iodine based preparation will occur first followed by the chlorhexidine based skin preparation. All groups will wait a minimal of 4 minutes prior to skin incision after application of skin prep, and all patients will be surgically draped with the standard drapes as if not participating in a study. Cesarean delivery will occur following the technique of the surgeon, including skin closure method, suture or staples.

All patients will be followed until the routine postpartum visit occurs at 6-8 weeks following delivery. Postpartum visit information will be extracted from the medical record. If no postpartum visit occurs, the patient will be contacted by telephone at 8 weeks post delivery and asked about any incisional complications which may have occurred and required treatment by as physician or healthcare provider in the office or hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1404
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Gestational age > 37 weeks 0/7 days

• Non-emergency indication for cesarean

Exclusion Criteria:

• Urogenital tract infection within 2 weeks prior to surgery

• Chronic oral or injectable steroid use (> 2 weeks)

• Emergency cesarean delivery

• Participation in another research study

Related Conditions & MeSH terms

• Surgical Site Infection Following Cesarean Delivery
• Surgical Wound Infection

Intervention

Drug:
• Iodine povidone
Iodine skin preparation solution prior to cesarean delivery
• Chlorhexidine
Chlorhexidine skin preparation solution prior to cesarean delivery
• Combination iodine and chlorhexidine
Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery

Locations

Country	Name	City	State
United States	Montefiore Medical Center Wakefield Division	The Bronx	New York
United States	Montefiore Medical Center Weiler Division	The Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. — View Citation

Gong SP, Guo HX, Zhou HZ, Chen L, Yu YH. Morbidity and risk factors for surgical site infection following cesarean section in Guangdong Province, China. J Obstet Gynaecol Res. 2012 Mar;38(3):509-15. doi: 10.1111/j.1447-0756.2011.01746.x. Epub 2012 Feb 22. — View Citation

Lobdell KW, Stamou S, Sanchez JA. Hospital-acquired infections. Surg Clin North Am. 2012 Feb;92(1):65-77. doi: 10.1016/j.suc.2011.11.003. Epub 2011 Dec 5. Review. — View Citation

Miner AL, Sands KE, Yokoe DS, Freedman J, Thompson K, Livingston JM, Platt R. Enhanced identification of postoperative infections among outpatients. Emerg Infect Dis. 2004 Nov;10(11):1931-7. — View Citation

Olsen MA, Butler AM, Willers DM, Gross GA, Hamilton BH, Fraser VJ. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol. 2010 Mar;31(3):276-82. doi: 10.1086/650755. — View Citation

Opøien HK, Valbø A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. — View Citation

Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. — View Citation

Stinner DJ, Krueger CA, Masini BD, Wenke JC. Time-dependent effect of chlorhexidine surgical prep. J Hosp Infect. 2011 Dec;79(4):313-6. doi: 10.1016/j.jhin.2011.08.016. Epub 2011 Oct 15. — View Citation

Zinn J, Jenkins JB, Harrelson B, Wrenn C, Haynes E, Small N. Differences in intraoperative prep solutions: a retrospective chart review. AORN J. 2013 May;97(5):552-8. doi: 10.1016/j.aorn.2013.03.006. Erratum in: AORN J. 2013 Jun;97(6):646. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean Surgical Site Infection	Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.	42 days after delivery