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

NCT05559697 | Completed FDA Device

• 1 other identifier: 1139
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

skin flora; incisional negative pressure wound therapy; dressing survivability

Outcome Measures

Primary Outcomes (1)

• Change in Skin Irritation Score

  Skin assessment is performed utilizing the Federal Drug Administration's Combined Evaluation of Skin Irritation and Sensitization utilized by the FDA for assessing topical delivery systems (https://www.fda.gov/media/117569/download). The assessments include photographs of the skin to document any noticeable differences between the two interventions visually. The dermal response score has eight levels between 0 and 7: 0:No evidence of irritation and 7: Strong reaction spreading beyond the dressing. Refer to the linked document for the entire scale The Other Effects Score (if present) has six characteristics associated with a numerical value: A(0): Slightly glazed appearance, B(1): Markedly glazed appearance, C(2): Glazing with peeling \& cracking, F(3): Glazing with fissures, G(3): Film of dried serous exudates covering all or part of the dressing site, H(3): Small petechial erosions and scabs. The sum of the two scores represents the total irritation score.

  Day 1 (Baseline) and Day 7

Secondary Outcomes (7)

• Change in skin flora bioburden

  Performed Day 1 (Baseline) and Day 7

• Dressing Discomfort Assessment

  Assessment performed once a day for 7 days by participant

• Intervention Tolerance Assessment

  Assessment performed once a day for 7 days by participant

• Change in Dressing Lift Incidence (Participant Assessment)

  Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7

• Change in Dressing Lift Incidence (Clinician Assessment)

  Clinician performs assessment at Day 7

Study Arms (2)

Prospera Flex Incisional NPWT System

EXPERIMENTAL

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

Prevena Incisional NPWT System

ACTIVE COMPARATOR

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

Interventions

Sponsor incisional negative pressure wound therapy device and dressing DEVICE

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

Prospera Flex Incisional NPWT System

Standard of Care incisional negative pressure wound therapy system 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.

Prevena Incisional NPWT System

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 40 to 80 years of age
• In good general health as evidenced by medical history
• Healthy skin located across both knees at the dressing site location
• No history of chronic knee pain
• 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
• Agreement to adhere to Lifestyle limitations throughout study duration
• Ability to understand and write in English

You may not qualify if:

• 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
• 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.
• History of skin irritation, skin sensitivity or skin disease including psoriasis, eczema, atopic dermatitis, and skin cancer.
• 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

Sponsors & Collaborators

• DeRoyal Industries, Inc.: lead
• Lincoln Memorial University: collaborator

Study Sites (1)

Lincoln Memorial University; Cedar Bluff Campus

Knoxville, Tennessee, 37923, United States

Location

Related Links

• Guidance Document defining Skin irritation and sensitization scale used as primary outcome

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Principal Investigator

  Lincoln Memorial University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 29, 2022
• Study Start: February 26, 2024
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)