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Human Repeat Insult Patch Test of Wound Dressings

NCT01368146 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2025-02-11

No results posted yet for this study

Summary

The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.

Conditions

  • Skin Sensitization

Interventions

DEVICE

IV Clear™

Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver

DEVICE

Tegaderm CHG™

Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate

DEVICE

Silicone Vehicle Control Dressing

Polyurethane film with silicone adhesive dressing, without antimicrobials

Sponsors & Collaborators

  • Covalon Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Micah Humphrey, B.S. · Hill Top Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

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 NCT01368146 on ClinicalTrials.gov