- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05559697
Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days (HHiNPWT7DC)
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 Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Research Scientist
- Phone Number: 8653621022
- Email: woundstudy@deroyal.com
Study Locations
-
-
Tennessee
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Knoxville, Tennessee, United States, 37923
- Lincoln Memorial University; Cedar Bluff Campus
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Contact:
- Principal Investigator
- Phone Number: 865-531-4155
- Email: woundstudy@deroyal.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
A sponsor incisional dressing placed on the knee and connected to a sponsor disposable negative pressure therapy device
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Active Comparator: Prevena Incisional NPWT System
Market leader incisional NPWT system (includes the device and dressing) placed on opposite knee for seven days.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Day 1 (Baseline) and Day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in skin flora bioburden
Time Frame: Performed Day 1 (Baseline) and Day 7
|
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.
|
Performed Day 1 (Baseline) and Day 7
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Dressing Discomfort Assessment
Time Frame: Assessment performed once a day for 7 days by participant
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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.
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Assessment performed once a day for 7 days by participant
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Intervention Tolerance Assessment
Time Frame: Assessment performed once a day for 7 days by participant
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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.
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Assessment performed once a day for 7 days by participant
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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
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Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
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Assessment performed once a day by participant for Days 1 - 6. Clinician performs assessment at Day 7
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Change in Dressing Lift Incidence (Clinician Assessment)
Time Frame: Clinician performs assessment at Day 7
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Calculate incidence rate of any dressing lift (lift or rolling) that occurs with each dressing
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Clinician performs assessment at Day 7
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Change in Dressing Lift Percentage (Participant Assessment)
Time Frame: Assessment performed once a day by participant for Days 1 - 6.
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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.
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Assessment performed once a day by participant for Days 1 - 6.
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Change in Dressing Lift Percentage (Clinician Assessment)
Time Frame: Clinician performs assessment at Day 7
|
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.
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Clinician performs assessment at Day 7
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Principal Investigator, Lincoln Memorial University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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