CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 293 enrolled
Drug / intervention
InteguSeal* skin sealant and standard surgical preparation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00467857
NCT00467857Phase 4Completed
CompareCT.gov

A Randomized, Controlled, Parallel Group, Multi-center, Open Label Study Comparing Common Surgical Skin Preparation Solutions in Combination With InteguSeal Versus Common Surgical Skin Preparation Solutions to Reduce Skin Flora Contamination.

Kimberly-Clark Corporation·interventional·Posted May 1, 2007·Updated Sep 18, 2012

In Brief

A Phase 4 clinical trial evaluating InteguSeal* skin sealant and standard surgical preparation and Standard preoperative skin preparation for Skin Flora Contamination. Completed, enrolled 293 participants across 5 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Flora Contamination
CountriesBrazil, Chile, Germany, Singapore, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 1, 2007
Enrollment StartApr 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.2 years ago

Interventions

InteguSeal* skin sealant and standard surgical preparationprocedure

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.

Standard preoperative skin preparationother

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