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Wound Dressing

Prospera Flex Incisional NPWT System for Allodynia (HHiNPWT7DC Trial)

N/A

Waitlist Available

Led By Principal Investigator

Research Sponsored by DeRoyal Industries, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 40 to 80 years of age

Healthy skin located across both knees at the dressing site location

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessment performed once a day by participant for days 1 - 6. clinician performs assessment at day 7

Awards & highlights

HHiNPWT7DC Trial Summary

This trial will compare a new incisional dressing with the standard of care to see if the new dressing is more comfortable and better at protecting against skin irritation and bacteria.

Who is the study for?

This trial is for men and women aged 40-80 with healthy skin across both knees, no chronic knee pain, and no history of certain skin conditions or allergies to dressing components. Women must use effective contraception. Participants must be in good health, willing to follow the study's lifestyle limitations, and able to understand/write English.Check my eligibility

What is being tested?

The study compares a new iNPWT dressing designed for better comfort and durability against the standard care iNPWT system. It will assess how well each manages incisional wounds by looking at skin irritation, dressing integrity, and bacterial levels on the skin after seven days.See study design

What are the potential side effects?

Potential side effects may include local skin irritation or allergic reactions related to the dressings used in either treatment group. The incidence of these reactions alongside any changes in bacteria on the skin will be monitored.

HHiNPWT7DC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old.

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The skin on both of my knees is healthy.

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I have never had chronic knee pain.

HHiNPWT7DC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessment performed once a day by participant for days 1 - 6. clinician performs assessment at day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessment performed once a day by participant for days 1 - 6. clinician performs assessment at day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment performed once a day by participant for days 1 - 6. clinician performs assessment at day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Skin Irritation Score

Secondary outcome measures

Change in Dressing Lift Incidence (Clinician Assessment)

Change in Dressing Lift Incidence (Participant Assessment)

Change in Dressing Lift Percentage (Clinician Assessment)

+4 more

HHiNPWT7DC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospera Flex Incisional NPWT SystemExperimental Treatment1 Intervention

Sponsor incisional dressing connected to sponsor disposable negative pressure device placed on knee for seven days.

Group II: Prevena Incisional NPWT SystemActive Control1 Intervention

Market leader incisional NPWT system (includes the device and dressing) placed on opposite knee for seven days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sponsor incisional negative pressure wound therapy device and dressing

2024

N/A

~20

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

DeRoyal Industries, Inc.Lead Sponsor

5 Previous Clinical Trials

733 Total Patients Enrolled

Lincoln Memorial UniversityOTHER

2 Previous Clinical Trials

51 Total Patients Enrolled

Principal InvestigatorPrincipal InvestigatorLincoln Memorial University

33 Previous Clinical Trials

4,053 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to become involved in this research study?

"According to clinicaltrials.gov, this medical research is no longer actively recruiting participants; its initial posting date was April 3rd 2023 and the last update occurred on October 27th 2022. Fortunately, there are 46 other trials seeking volunteers at present."

Answered by AI

To which population is enrollment in this research open?

"This research is seeking 16 participants with skin condition and an age range of 40 to 80 years. Those who meet these requirements can apply for the study."

Answered by AI

Is the age range for this research study limited to those over 35 years of age?

"Qualified applicants must be between 40 and 80 years old to participate in this medical trial. For younger patients, there are 14 studies available while 38 trials are open for people over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05559697.