DeRoyal Industries, Inc.
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.
Skin Reaction to Mechanical, Thermal and Radiation Stimuli
Skin Sensitisation
Sponsor incisional negative pressure wound therapy device and dressing
Standard of Care incisional negative pressure wound therapy system
Not Applicable
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 16 participants |
Masking : | Double |
Masking Description : | 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. |
Primary Purpose : | Prevention |
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 |
Actual Study Start Date : | February 26, 2024 |
Estimated Primary Completion Date : | March 7, 2024 |
Estimated Study Completion Date : | March 7, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Prospera Flex Incisional NPWT System 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 |
Active Comparator: Prevena Incisional NPWT System 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 |
Ages Eligible for Study: | 40 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Lincoln Memorial University; Cedar Bluff Campus
Knoxville, Tennessee, United States, 37923