Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days (HHiNPWT7DC)

DeRoyal Industries

Status: Completed

Conditions: Skin Reaction to Mechanical, Thermal and Radiation Stimuli; Skin Sensitisation

Treatments: Device: Sponsor incisional negative pressure wound therapy device and dressing; Device: Standard of Care incisional negative pressure wound therapy system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05559697

1139

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Prospera Flex Incisional NPWT System

Experimental group

Description:

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

Treatment:

Device: Sponsor incisional negative pressure wound therapy device and dressing

Prevena Incisional NPWT System

Active Comparator group

Description:

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

Treatment:

Device: Standard of Care incisional negative pressure wound therapy system