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Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

NCT03365934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-06-04

Study results available
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Summary

This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

ADHESIVE BANDAGE #1

Bandage applied daily to wounded site for 14 days

DEVICE

ADHESIVE BANDAGE #2

Bandage applied daily to wounded site for 14 days

DEVICE

ADHESIVE BANDAGE #3

Bandage applied daily to wounded site for 14 days

DEVICE

Antibacterial Bandage with 0.8% BZK

bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days

OTHER

Intact and No Bandage

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

OTHER

Wounded and No Bandage

This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Philip Lastella, MD · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2018-02-12
Completion
2018-02-12
FDA Device
Yes

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 NCT03365934 on ClinicalTrials.gov