The Skin Prep Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Methodius Tuuli, MD, MPH, Washington University
ClinicalTrials.gov Identifier:
NCT01472549
First received: September 20, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result in significant human suffering and excess health care costs. Interventions such as preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high. There is therefore a great need to identify and test other potential interventions to further reduce these infections.

The skin is a major source of pathogens that cause surgical site infection. Therefore, optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical site infections. There is paucity of evidence to guide the choice of antiseptic for skin preparation at cesarean section. To date, only two underpowered trials have been published comparing two methods of preoperative skin preparation at cesarean section. A recent randomized trial in adults undergoing clean-contaminated mostly general surgical procedures demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is plausible that findings from trials in other clean-contaminated surgical procedures may apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related infections and the hormone-mediated immune-modulation in pregnancy make the validity of such extrapolation uncertain.

The study has the following specific aims:

Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces surgical site infections compared to iodine-alcohol.

Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces bacterial contamination at the surgical site compared to iodine-alcohol.

Secondary Aim 2: To determine clinical outcomes and medical costs associated with cesarean-related infections and quantify potential cost savings attributable to use of chlorhexidine-alcohol for preoperative skin preparation at cesarean section.


Condition Intervention
Surgical Site Infections
Drug: Iodine-alcohol
Drug: Chlorhexidine-alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of re-admissions and office visits for wound-related problems [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Endometritis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Allergic reaction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Proportion of patients with skin contamination after skin prep [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Cost savings [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iodine-alcohol Drug: Iodine-alcohol
Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
Other Name: Prevail-FX, Cardinal Health
Experimental: Chlorhexidine-alcohol Drug: Chlorhexidine-alcohol
Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
Other Name: ChloraPrep, Cardinal Health

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing cesarean delivery at Barnes-Jewish Hospital.

Exclusion Criteria:

  • Inability to obtain consent; allergy to chlorhexidine, alcohol, iodine, shellfish; and evidence of infection adjacent to operative site.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472549

Locations
United States, Missouri
Barnes-Jewish Hospital Recruiting
St Louis, Missouri, United States, 63108
Contact: Methodius G Tuuli, MD, MPH    314-362-4224    tuulim@wudosis.wustl.edu   
Principal Investigator: Methodius G Tuuli, MD, MPH         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Methodius G Tuuli, MD, MPH Washington University Early Recognition Center
Study Chair: George Macones, MD, MSCE Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: Methodius Tuuli, MD, MPH, Principal Investigator, Washington University
ClinicalTrials.gov Identifier: NCT01472549     History of Changes
Other Study ID Numbers: IRB ID #: 201105161
Study First Received: September 20, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Preoperative
Antiseptics
Comparative
Cost
Effectiveness

Additional relevant MeSH terms:
Infection
Communicable Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on September 22, 2014