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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sponsor incisional negative pressure wound therapy device and dressing
Standard of Care incisional negative pressure wound therapy system
Sponsored by
DeRoyal Industries, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Reaction to Mechanical, Thermal and Radiation Stimuli focused on measuring skin flora, incisional negative pressure wound therapy, dressing survivability

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Lincoln Memorial University; Cedar Bluff Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prospera Flex Incisional NPWT System

Prevena Incisional NPWT System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in skin flora bioburden
Sterile skin swabs will be performed on approximately a 1 by 1 inch area of the knee cap on day 1 after skin prep and day 7 after removal of the dressings. Swabs will undergo bioburden testing to recover any organisms present on the skin. Day 0 assessments confirms the efficacy of the skin preparation procedure and day 7 measurements reflect rebound of skin flora under the two interventions.
Dressing Discomfort Assessment
Healthy volunteer self assessment using a visual analogue scale to rate pain/discomfort experienced during study. Volunteers will mark on a 10 cm line their assessment of discomfort. No pain or discomfort indicated by a score of 0. Extreme pain or discomfort indicated by a score of 10.
Intervention Tolerance Assessment
Healthy volunteer self assessment using a visual analogue scale to rate tolerance of each intervention during the study. Tolerance includes assessment of sound and impact on daily life. Volunteers will mark on a 10 cm line their assessment of discomfort. A score of 0 indicates intervention completely tolerable, does not interfere with daily living. A score of 10 indicates intervention completely intolerable, makes daily living impossible.
Change in Dressing Lift Incidence (Participant Assessment)
Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
Change in Dressing Lift Incidence (Clinician Assessment)
Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
Change in Dressing Lift Percentage (Participant Assessment)
The participant or clinician research uses a dressing diagram to indicate dressing lift or damage. Final analysis will calculate the percent area where damage occurred. A separate photograph of the dressing will confirm final assessment.
Change in Dressing Lift Percentage (Clinician Assessment)
The participant or clinician research uses a dressing diagram to indicate dressing lift or damage. Final analysis will calculate the percent area where damage occurred. A separate photograph of the dressing will confirm final assessment.

Full Information

First Posted
September 9, 2022
Last Updated
September 5, 2023
Sponsor
DeRoyal Industries, Inc.
Collaborators
Lincoln Memorial University
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1. Study Identification

Unique Protocol Identification Number
NCT05559697
Brief Title
Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
Acronym
HHiNPWT7DC
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 3, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DeRoyal Industries, Inc.
Collaborators
Lincoln Memorial University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Reaction to Mechanical, Thermal and Radiation Stimuli, Skin Sensitisation
Keywords
skin flora, incisional negative pressure wound therapy, dressing survivability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Healthy human knees are prepped as if for total knee replacement. Incisional negative pressure dressings are applied to both knees.
Masking
InvestigatorOutcomes Assessor
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.
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospera Flex Incisional NPWT System
Arm Type
Experimental
Arm Description
Sponsor incisional dressing connected to sponsor disposable negative pressure device placed on knee for seven days.
Arm Title
Prevena Incisional NPWT System
Arm Type
Active Comparator
Arm Description
Market leader incisional NPWT system (includes the device and dressing) placed on opposite knee for seven days.
Intervention Type
Device
Intervention Name(s)
Sponsor incisional negative pressure wound therapy device and dressing
Intervention Description
A sponsor incisional dressing placed on the knee and connected to a sponsor disposable negative pressure therapy device
Intervention Type
Device
Intervention Name(s)
Standard of Care incisional negative pressure wound therapy system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Skin Irritation Score
Description
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.
Time Frame
Day 1 (Baseline) and Day 7
Secondary Outcome Measure Information:
Title
Change in skin flora bioburden
Description
Sterile skin swabs will be performed on approximately a 1 by 1 inch area of the knee cap on day 1 after skin prep and day 7 after removal of the dressings. Swabs will undergo bioburden testing to recover any organisms present on the skin. Day 0 assessments confirms the efficacy of the skin preparation procedure and day 7 measurements reflect rebound of skin flora under the two interventions.
Time Frame
Performed Day 1 (Baseline) and Day 7
Title
Dressing Discomfort Assessment
Description
Healthy volunteer self assessment using a visual analogue scale to rate pain/discomfort experienced during study. Volunteers will mark on a 10 cm line their assessment of discomfort. No pain or discomfort indicated by a score of 0. Extreme pain or discomfort indicated by a score of 10.
Time Frame
Assessment performed once a day for 7 days by participant
Title
Intervention Tolerance Assessment
Description
Healthy volunteer self assessment using a visual analogue scale to rate tolerance of each intervention during the study. Tolerance includes assessment of sound and impact on daily life. Volunteers will mark on a 10 cm line their assessment of discomfort. A score of 0 indicates intervention completely tolerable, does not interfere with daily living. A score of 10 indicates intervention completely intolerable, makes daily living impossible.
Time Frame
Assessment performed once a day for 7 days by participant
Title
Change in Dressing Lift Incidence (Participant Assessment)
Description
Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
Time Frame
Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7
Title
Change in Dressing Lift Incidence (Clinician Assessment)
Description
Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
Time Frame
Clinician performs assessment at Day 7
Title
Change in Dressing Lift Percentage (Participant Assessment)
Description
The participant or clinician research uses a dressing diagram to indicate dressing lift or damage. Final analysis will calculate the percent area where damage occurred. A separate photograph of the dressing will confirm final assessment.
Time Frame
Assessment performed once a day by participant for Days 1 - 6.
Title
Change in Dressing Lift Percentage (Clinician Assessment)
Description
The participant or clinician research uses a dressing diagram to indicate dressing lift or damage. Final analysis will calculate the percent area where damage occurred. A separate photograph of the dressing will confirm final assessment.
Time Frame
Clinician performs assessment at Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Scientist
Phone
8653621022
Email
woundstudy@deroyal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Organizational Affiliation
Lincoln Memorial University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lincoln Memorial University; Cedar Bluff Campus
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
865-531-4155
Email
woundstudy@deroyal.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.fda.gov/media/117569/download
Description
Guidance Document defining Skin irritation and sensitization scale used as primary outcome

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

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