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Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination

NCT00467857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2012-09-18

Study results available
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Summary

The purpose of this study is to determine if there is a qualitative reduction in microbial skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant is used in combination with a surgical skin preparation solution.

Conditions

  • Skin Flora Contamination

Interventions

PROCEDURE

InteguSeal* skin sealant and standard surgical preparation

Surgical skin preparation prior to incision using InteguSeal\* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

OTHER

Standard preoperative skin preparation

Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.

Sponsors & Collaborators

  • Kimberly-Clark Corporation

    lead INDUSTRY

Principal Investigators

  • Charlotte D Owens, MD · Kimberly-Clark Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Brazil
  • Chile
  • Germany
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00467857 on ClinicalTrials.gov