NCT05559697

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: DeRoyal Industries, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Reaction to Mechanical, Thermal and Radiation Stimuli
• Skin Sensitisation

Interventions

Type	Name	Description
DEVICE	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
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.

Timeline

• Start date: 2024-02-26
• Primary completion: 2024-03-07
• Completion: 2024-03-07
• First posted: 2022-09-29
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study