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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-03-07

Brief Summary

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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.

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Detailed Description

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The study compares the DeRoyal Negative Pressure Wound Therapy Incisional Dressing used with the DeRoyal Disposable NPWT device (experimental) to the market leader NPWT Incision Dressing system (control) over seven days to compare skin flora rebound, dressing degradation, skin irritation, and overall user experience. The protocol simulates the preparation of both knees for total knee replacement surgery (Day 0). After prepping the knee (shaving and chlorohexidine gluconate scrub), research personnel will swab the knee cap for an initial bioburden assessment. One knee is randomized to receive the experimental intervention, and the other knee receives the control intervention. Participants will wear both dressings for seven days documenting interruptions in the NPWT for activities of daily living, system-related discomfort, self-assessment of dressing damage, and tolerance for each system. Participants return to the clinic after seven days. First, research personnel will document each dressing's condition with photography and an assessment scale. The research staff will remove dressings under aseptic conditions, photograph each knee, and swab each for bioburden analysis. A blinded researcher will assess each knee for skin redness, irritation, blistering, or other skin adverse event and overall appearance using an adapted FDA scale for skin irritation. The participant's participation in the trial ends at this point. The resulting data will be analyzed using statistical methods to inform on differences in bioburden present under each dressing, the incidence of skin irritation or other adverse events, dressing survivability, discomfort differences, and tolerance of each system.

Conditions

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Skin Reaction to Mechanical, Thermal and Radiation Stimuli Skin Sensitisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Healthy human knees are prepped as if for total knee replacement. Incisional negative pressure dressings are applied to both knees.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Prospera Flex Incisional NPWT System

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

Group Type EXPERIMENTAL

Sponsor incisional negative pressure wound therapy device and dressing

Intervention Type DEVICE

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

Prevena Incisional NPWT System

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

Group Type ACTIVE_COMPARATOR

Standard of Care incisional negative pressure wound therapy system

Intervention Type DEVICE

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.

Interventions

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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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 40 to 80 years of age
4. In good general health as evidenced by medical history
5. Healthy skin located across both knees at the dressing site location
6. No history of chronic knee pain
7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study
8. Agreement to adhere to Lifestyle limitations throughout study duration
9. Ability to understand and write in English

Exclusion Criteria

1. The presence of localized skin conditions, such as scaring, local discoloration, tattoos, freckles, birthmarks, moles or other skin abnormality, that may impair assessment of skin as judged by the clinician
2. Known allergic reactions to components of the Prevena Dressing, DeRoyal Incisional dressing, Hibiclens or a history of skin irritation allergic reaction to chlorohexidine, isopropyl alcohol, chlorohexidine gluconate, or silver.
3. History of skin irritation, skin sensitivity or skin disease including psoriasis, eczema, atopic dermatitis, and skin cancer.
4. Pregnant or lactating female

Lifestyle Limitations during the Study:

During this study, participants are asked to adhere to following lifestyle limitations:

* Abstain from strenuous exercise activity such as running, playing contact sports, biking, and yard work. Participants may walk at a slow pace.
* To keep both dressings shielded from sunlight and fluorescent light (e.g. wear pants or cover with elastic bandage)
* To protect dressing and not expose to high moisture/water submersion environment.
* Limit showering to once per day
* To keep the NPWT devices on and connected to dressing at all times except when showering and changing clothes

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes