Trials Sponsors Conditions Drugs Pricing

Conditions

Skin Reaction to Mechanical, Thermal and Radiation Stimuli Skin Sensitisation

Keywords

skin floraincisional negative pressure wound therapydressing survivability

Outcome Measures

Primary Outcomes (1)

Change in Skin Irritation Score
Skin assessment is performed utilizing the Federal Drug Administration's Combined Evaluation of Skin Irritation and Sensitization utilized by the FDA for assessing topical delivery systems (https://www.fda.gov/media/117569/download). The assessments include photographs of the skin to document any noticeable differences between the two interventions visually. The dermal response score has eight levels between 0 and 7: 0:No evidence of irritation and 7: Strong reaction spreading beyond the dressing. Refer to the linked document for the entire scale The Other Effects Score (if present) has six characteristics associated with a numerical value: A(0): Slightly glazed appearance, B(1): Markedly glazed appearance, C(2): Glazing with peeling \& cracking, F(3): Glazing with fissures, G(3): Film of dried serous exudates covering all or part of the dressing site, H(3): Small petechial erosions and scabs. The sum of the two scores represents the total irritation score.
Day 1 (Baseline) and Day 7

Secondary Outcomes (7)

Change in skin flora bioburden
Performed Day 1 (Baseline) and Day 7
Dressing Discomfort Assessment
Assessment performed once a day for 7 days by participant
Intervention Tolerance Assessment
Assessment performed once a day for 7 days by participant
Change in Dressing Lift Incidence (Participant Assessment)
Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7
Change in Dressing Lift Incidence (Clinician Assessment)
Clinician performs assessment at Day 7
+2 more secondary outcomes

Study Arms (2)

Prospera Flex Incisional NPWT System

EXPERIMENTAL

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

Device: Sponsor incisional negative pressure wound therapy device and dressing

Prevena Incisional NPWT System

ACTIVE COMPARATOR

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

Device: Standard of Care incisional negative pressure wound therapy system

Interventions

Sponsor incisional negative pressure wound therapy device and dressingDevice

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

Prospera Flex Incisional NPWT System

Standard of Care incisional negative pressure wound therapy systemDevice

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.

Eligibility Criteria

Age40 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study

Sponsors & Collaborators

DeRoyal Industries, Inc.
Industrylead
Lincoln Memorial University
Othercollaborator

Study Sites (1)

Lincoln Memorial University; Cedar Bluff Campus

Knoxville, Tennessee, 37923, United States

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

Principal Investigator
Lincoln Memorial University
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Clinician research performing skin assessment masked from knee assignment to two interventions. Before the assessment, a separate clinician will remove the dressings and perform other measurements. The investigator performing data analysis will not know group assignment until unblinding.
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 29, 2022

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Prospera Flex Incisional NPWT System

Prevena Incisional NPWT System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Prospera Flex Incisional NPWT System

Prevena Incisional NPWT System

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations