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Comparison of Surgical Skin Preps During Cesarean Deliveries

NCT ID: NCT01870583

Last Updated: 2017-10-02

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Site Infection Following Cesarean Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Combination iodine and chlorhexidine

The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.

Group Type ACTIVE_COMPARATOR

Combination iodine and chlorhexidine

Intervention Type DRUG

Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery

Chlorhexidine

Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

Chlorhexidine skin preparation solution prior to cesarean delivery

Iodine povidone

Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery

Group Type ACTIVE_COMPARATOR

Iodine povidone

Intervention Type DRUG

Iodine skin preparation solution prior to cesarean delivery

Interventions

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Iodine povidone

Iodine skin preparation solution prior to cesarean delivery

Intervention Type DRUG

Chlorhexidine

Chlorhexidine skin preparation solution prior to cesarean delivery

Intervention Type DRUG

Combination iodine and chlorhexidine

Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Garry

Co-Director Obstetrics & MFM service Wakefield Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Wallach, CIP

Role: STUDY_CHAIR

Einstein IRB

Locations

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Montefiore Medical Center Weiler Division

The Bronx, New York, United States

Site Status

Montefiore Medical Center Wakefield Division

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22269261 (View on PubMed)

Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. doi: 10.1016/s0001-2092(06)61035-1.

Reference Type BACKGROUND
PMID: 12463081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23622828 (View on PubMed)

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. doi: 10.1128/jcm.15.4.635-639.1982.

Reference Type BACKGROUND
PMID: 7040461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22000737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20102279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22353388 (View on PubMed)

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. doi: 10.3201/eid1011.040784.

Reference Type BACKGROUND
PMID: 15550202 (View on PubMed)

Opoien HK, Valbo 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. doi: 10.1080/00016340701515225.

Reference Type BACKGROUND
PMID: 17712651 (View on PubMed)

Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.

Reference Type DERIVED
PMID: 32580252 (View on PubMed)

Ngai IM, Van Arsdale A, Govindappagari S, Judge NE, Neto NK, Bernstein J, Bernstein PS, Garry DJ. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1251-1257. doi: 10.1097/AOG.0000000000001118.

Reference Type DERIVED
PMID: 26551196 (View on PubMed)

Other Identifiers

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CCI#12-07-248

Identifier Type: -

Identifier Source: org_study_id