Clinical trial NCT05559697: Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
Official title: Healthy Human Study on DeRoyal Incisional Dressing With NPWT Compared Against Standard of Care NPWT Incision Dressing to Investigate Bioburden Levels and Skin Condition After Seven Day Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Reaction to Mechanical, Thermal and Radiation Stimuli
Skin Sensitisation
Keywords: skin flora
incisional negative pressure wound therapy
dressing survivability
Lead sponsor: DeRoyal Industries, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lincoln Memorial University
First posted: 2022-09-29
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy human knees are prepped as if for total knee replacement. Incisional negative pressure dressings are applied to both knees.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Skin Irritation Score
timeFrame: Day 1 (Baseline) and Day 7
Secondary outcomes:
measure: Change in skin flora bioburden
timeFrame: Performed Day 1 (Baseline) and Day 7
measure: Dressing Discomfort Assessment
timeFrame: Assessment performed once a day for 7 days by participant
measure: Intervention Tolerance Assessment
timeFrame: Assessment performed once a day for 7 days by participant
measure: Change in Dressing Lift Incidence (Participant Assessment)
timeFrame: Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7
measure: Change in Dressing Lift Incidence (Clinician Assessment)
timeFrame: Clinician performs assessment at Day 7
measure: Change in Dressing Lift Percentage (Participant Assessment)
timeFrame: Assessment performed once a day by participant for Days 1 - 6.
measure: Change in Dressing Lift Percentage (Clinician Assessment)
timeFrame: Clinician performs assessment at Day 7
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Lincoln Memorial University; Cedar Bluff Campus
state: Tennessee
Study officials:
affiliation: Lincoln Memorial University
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: