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Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days

NCT05559697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-12

No results posted yet for this study

Summary

Incisional dressings aim to prevent contamination of an incisional wound and protect against skin irritation. Surgeons use incisional negative pressure wound therapy (iNPWT) to manage incisional wounds. This study compares a new dressing designed for use with iNPWT that aims to improve comfort, tolerability, and dressing survivability over the standard of care for iNPWT. Further, no evidence exists that shows NPWT reduces the bacterial burden on the skin. This study will compare the incidence of skin irritation, dressing damage or lift, and changes in bacteria flora on healthy volunteer skin.

Conditions

  • Skin Reaction to Mechanical, Thermal and Radiation Stimuli
  • Skin Sensitisation

Interventions

DEVICE

Sponsor incisional negative pressure wound therapy device and dressing

A sponsor incisional dressing placed on the knee and connected to a sponsor disposable negative pressure therapy device

DEVICE

Standard of Care incisional negative pressure wound therapy system

The control incisional negative pressure wound therapy system represents the standard of care system and market leader. It consists of a disposable negative pressure therapy device and incisional dressing.

Sponsors & Collaborators

  • Lincoln Memorial University

    collaborator OTHER

  • DeRoyal Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · Lincoln Memorial University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2024-03-07
Completion
2024-03-07
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 NCT05559697 on ClinicalTrials.gov