Skin Reaction to Mechanical, Thermal and Radiation StimuliHHiNPWT7DCNCT05559697
Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
A study testing Sponsor incisional negative pressure wound therapy device and dressing in people with Skin Reaction to Mechanical, Thermal and Radiation Stimuli and Skin Sensitisation, run by DeRoyal Industries, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Reaction to Mechanical, Thermal and Radiation Stimuli, Skin Sensitisation
- What is being tested?
- Sponsor incisional negative pressure wound therapy device and dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lincoln Memorial University; Cedar Bluff Campus
Knoxville, Tennessee, 37923
About this study
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
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.
Read the 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.
- Being tested
- Sponsor incisional negative pressure wound therapy device and dressing, Standard of Care incisional negative pressure wound therapy system
- Keywords
- skin flora, incisional negative pressure wound therapy, dressing survivability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponsor incisional negative pressure wound therapy device and dressingDevice
A sponsor incisional dressing placed on the knee and connected to a sponsor disposable negative pressure therapy device
Standard of Care incisional negative pressure wound therapy systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Prospera Flex Incisional NPWT System | Experimental | Sponsor incisional dressing connected to sponsor disposable negative pressure device placed on knee for seven days. Receives: 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. Receives: Device: Standard of Care incisional negative pressure wound therapy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (Baseline) and Day 7
Secondary outcomes (7)
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.
Measured: Performed Day 1 (Baseline) and Day 7
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.
Measured: Assessment performed once a day for 7 days by participant
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.
Measured: Assessment performed once a day for 7 days by participant
Change in Dressing Lift Incidence (Participant Assessment)
Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
Measured: Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7
Change in Dressing Lift Incidence (Clinician Assessment)
Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
Measured: Clinician performs assessment at Day 7
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.
Measured: Assessment performed once a day by participant for Days 1 - 6.
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.
Measured: Clinician performs assessment at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start26 Feb 2024
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Reaction to Mechanical, Thermal and Radiation StimuliStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy human knees are prepped as if for total knee replacement. Incisional negative pressure dressings are applied to both knees.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeRoyal Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lincoln Memorial University
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, Lincoln Memorial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559697
- Sponsor's protocol ID
- 1139
- Acronym
- HHiNPWT7DC
- Status last verified
- Mar 2024
- First submitted
- 9 Sep 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05559697
- Acronym / sponsor ID
- HHiNPWT7DC / 1139
- Keywords
- skin flora, incisional negative pressure wound therapy, dressing survivability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- DeRoyal Industries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lincoln Memorial University
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Healthy human knees are prepped as if for total knee replacement. Incisional negative pressure dressings are applied to both knees.
| Arm | Type | Receives |
|---|---|---|
| Prospera Flex Incisional NPWT System | Experimental | Device: Sponsor incisional negative pressure wound therapy device and dressingSponsor incisional dressing connected to sponsor disposable negative pressure device placed on knee for seven days. |
| Prevena Incisional NPWT System | Active comparator | Device: Standard of Care incisional negative pressure wound therapy systemMarket leader incisional NPWT system (includes the device and dressing) placed on opposite knee for seven days. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- Abstain from strenuous exercise activity such as running, playing contact sports, biking, and yard work. Participants may walk at a slow pace.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sponsor incisional negative pressure wound therapy device and dressingA sponsor incisional dressing placed on the knee and connected to a sponsor disposable negative pressure therapy device | Device | Prospera Flex Incisional NPWT System |
| Standard of Care incisional negative pressure wound therapy systemThe 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. | Device | Prevena Incisional NPWT System |
Primary outcome
Change in Skin Irritation Score
Time frame: Day 1 (Baseline) and Day 7
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.
7 secondary outcomes
Change in skin flora bioburden
Time frame: Performed Day 1 (Baseline) and Day 7
Dressing Discomfort Assessment
Time frame: Assessment performed once a day for 7 days by participant
Intervention Tolerance Assessment
Time frame: Assessment performed once a day for 7 days by participant
Change in Dressing Lift Incidence (Participant Assessment)
Time frame: Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7
Change in Dressing Lift Incidence (Clinician Assessment)
Time frame: Clinician performs assessment at Day 7
Change in Dressing Lift Percentage (Participant Assessment)
Time frame: Assessment performed once a day by participant for Days 1 - 6.
Change in Dressing Lift Percentage (Clinician Assessment)
Time frame: Clinician performs assessment at Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Guidance Document defining Skin irritation and sensitization scale used as primary outcomeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator principal investigator
Lincoln Memorial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sponsor incisional negative pressure wound therapy device and dressing in people with Skin Reaction to Mechanical, Thermal and Radiation Stimuli and Skin Sensitisation, run by DeRoyal Industries, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Irritation Score (time frame: Day 1 (Baseline) and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.