A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects
Phase: NA
Conditions: Skin Wound, Soft Tissue Injuries
Sponsor: The Metis Foundation

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Protocol Number: NP-PWD-02 
Protocol Date and Version #:09 February 2024, V2 
PROTOCOL TITLE:   A Case-Control Study of Negative Pressure Platform Wound 
Devices (NP-PWD) for Skin and Soft Tissue Defects 
 
SECTION A:  RESEARCH TEAM AND LOCATIONS 
 
A1.  RESEARCH TEAM 
 
Study Role 
Institution/Company and Contact Information 
 
 
Principal Investigator and 
Sponsor 
Rodney K. Chan, MD  
Principal Investigator 
The Metis Foundation  
210-569-1110 
chan@metisfoundationusa.org  
 
Key Research  
Personnel  
Victoria Diaz, RN 
Research Project Manager 
The Metis Foundation  
210-569-1110 
diaz@metisfoundationusa.org    
Kristin Anselmo, RN 
Clinical Research Nurse 
The Metis Foundation 
210-569-1110 
kanselmo@metisfoundationusa.org 
A2.  RESEARCH LOCATIONS    
Northeast Baptist Hospital 
 
A3. MULTISITE RESEARCH      N/A 
 
B.  SOURCE OF EXTERNAL FUNDING 
 
Applied Tissue Technologies 
 
C1. HYPOTHESIS/STUDY SYNOPSIS  

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Hypothesis: The Negative Pressure Platform Wound Device (NP-PWD) technology is a feasible 
alternative to manage skin and soft tissue defects as compared to standard of care, KCI Wound 
VAC granulofoam. 
Study Synopsis:  This study will demonstrate the effectiveness of the NP-PWD therapy in 
managing complex wounds and improving wound healing parameters as compared to standard of 
care.  
 
A study of 24 completed subjects will be conducted by enrolling patients who are requiring 
treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and 
asked to consent to participate in the study. Following consent subjects will be randomized to 
receive treatment of one of the two study arms. Arm 1, the standard of care arm, will receive 
KCI Wound VAC Granulofoam. Arm 2, the study arm, will receive treatment with NP-PWD. 
Prior to the initial application, wound evaluations and photography will be completed to include 
assessment of infection with wound swabs. The wound dressing will be assessed for the need for 
change every 2-3 days and changed if clinically indicated (following each device IFU). Subjects 
will be followed for up to nine days post initial application. At minimum, the randomized 
treatment will be applied for 2 days after initial application for a subject to be considered 
completed. Subject who do not complete the treatment course (minimum of 2 days of treatment), 
may be replaced per investigators discretion. Follow up data will be gathered at each 
change/removal of the NP-PWD or Wound VAC. The data collected will include indications for 
dressing change, dressing change process, photographs and assessments for wound healing, 
infection, and adverse events. Gathered clinical data of the enrolled subjects will be used to 
evaluate the feasibility in using the NP-PWD device for wound healing management. 
 
C2.  BACKGROUND    
 
 
Open complex wounds are a prominent issue, as unhealed or untreated wounds pose a risk of 
microbial infection. The Negative Pressure Platform Wound Device or NP-PWD, is an 
innovative therapy which uses a patented dressing to promote healing by creating a vacuum 
(negative pressure) at the wound site without the use of an intervening foam dressing. This 
pressure promotes granulation of the skin, forming new connective tissue and blood vessels, 
removes or inhibits microbial and infectious agents, as well as pulls wound edges together for 
closure. Although this therapy is evolving, the review of elements and effects on wounds is still 
uncertain and requires further studies regarding the mechanism and use of NP-PWD in wound 
healing.  
 
C3.  OBJECTIVES/STUDY GOALS   
 
This study is intended to evaluate the feasibility of the NP-PWD as compared to SOC for the 
treatment of wound healing through assessment of healing time, feasibility of application, patient 

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comfort, and adverse events. 
 
Primary: 
To determine the usability and feasibility of NP-PWD in comparison to SoC 
Secondary: 
- 
To evaluate and compare wound readiness for closure between study wounds treated with 
NP-PWD versus SoC 
- 
To evaluate colony forming units present on study wounds before and after treatment(s) 
- 
To evaluate the ease of use of the product by healthcare providers 
- 
To evaluate tolerability of the product by patient subjects 
C4. SUBJECT SELECTION 
 
Twenty-four (24) patients, 18 years of age or older, who are requiring treatment for open skin 
and soft tissue defect at a hospital within the Baptist Health System will be recruited for 
participation in this study. Potential subjects must meet the following inclusion and exclusion 
criteria to be included in this study.  
 
Inclusion Criteria  
All subjects enrolled must meet ALL the following criteria: 
1. 
Patients 18 years of age or older of either gender  
2. 
Have an open skin or soft tissue defect requiring treatment  
 
Exclusion Criteria  
Subjects who meet any of the following criteria will be excluded from the study: 
1. Active malignant disease at the study site 
2. Any concomitant medications or co-morbidities that, in the opinion of the investigator, 
may interfere with device use  
3. On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days 
or any previous enrollment in this study 
4. Pregnant at enrollment 
When a potential subject is identified a member of the research staff will approach the potential 
subject or their legally authorized representative (LAR) and introduce the proposed study. If a 
potential subject or their LAR expresses interest in participation in the study, the PI or designated 
study personnel will proceed with the informed consent process for potential enrollment.  
 
D. STUDY PROCEDURES/ RESEARCH METHODS   
 

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Informed consent of potential subjects will be done in a quiet and private area of the patient care 
setting (hospital or clinic office) to ensure patient confidentiality. The PI or designated study 
staff will discuss and explain elements of the study with the informed consent document. The PI 
or designated study staff will also be available to answer questions for the potential subject.  
 
A copy of the IRB-approved informed consent document will be given to the potential subject 
for their review and ample time will be given for their decision making. If the potential subject 
decides to participate, the IRB-approved informed consent document will be signed and dated 
appropriately by all persons required on the document. The original signed consent document 
will be kept in the study files; a copy will be given to the subject and a copy will be placed in the 
subject’s medical record. 
 
Study procedures will not begin until eligibility is determined, and the informed consent process 
is completed. Patients who sign the informed consent form are considered to be enrolled. If a 
patient signs the consent but is not randomized into the study, the patient is considered a screen 
failure. 
 
Subjects will be enrolled for up to 9 days following application of the NP-PWD or Wound VAC. 
At minimum, the randomized treatment will be applied for a minimum of 2 days after initial 
application for a subject to be considered completed. Subject who do not complete the treatment 
course (minimum of 2 days of treatment), may be replaced per investigators discretion.  
 
Activities to be completed for each visit are as follows: 
 
Treatment (Day 0): Screening, consent, documentation of baseline demographics, medical 
history and physical, measurement and photography of wound, wound swab for colony forming 
unit count, randomization, and application of NP-PWD or Wound Vac according to 
randomization. 
 
Follow-up visits: 
 
At each follow-up visit the study wound will be assessed for the need for dressing change (every 
2-3 days) and changed if clinically indicated (following the respective device’s IFU). The study 
wound sites will be assessed for signs of infection, erythema, itching, drainage, quality of closure 
and pain. 
 
Follow-up (Visit 2): Assessment of need for dressing change and completion of change of 
treatment dressing if necessary. Should the study subject’s wound indicate continuation of 
negative pressure wound therapy a second application of the randomized treatment may be 
applied. If the subject no longer requires negative pressure wound therapy, the therapy will be 

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discontinued. Wound assessments, measurements, photographs, assessments for adverse events 
will all be completed and documented. 
 
Optional Follow-up (Visit 3 & 4): Assessment of need for change of treatment dressing, 
reapplication if necessary or removal, wound assessment, measurements, photographs, assess for 
adverse events. 
 
If negative pressure wound therapy is no longer indicated at any time after the minimum 
requirement of 2has been met, the therapy will be discontinued and assessments will be 
completed to include a final wound swab, and the subject’s participation will end.  
 
Schedule of Events 
 
Research 
Procedures 
Visit 1 
Day 0 
Visit 2 
Day 2-3 
Visit 3 
Day 5-6 
(Optional) 
Visit 4 
Days 7-9 
(Optional) 
Assessment of 
Eligibility 
X 
 
 
 
Informed Consent 
X 
 
 
 
Demographics and 
H&P 
X 
 
 
 
Wound assessment 
X 
X 
X 
X 
Photography 
X 
X 
X 
X 
Randomization 
X 
 
 
 
Assessment of 
need for dressing 
change 
 
X 
X 
X 
Treatment 
application 
X 
X* 
X* 
 
Wound swab 
(CFU)^ 
X 
 
 
X 
Adverse event 
assessment 
X 
X 
X 
X 

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*At minimum the treatment will be applied once but can be applied up to three times. Visits 3 
and 4 are optional.  
^ The wound swab will be taken once at baseline and once at the time of final removal. 

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Study Intervention Flow Chart 

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Data Collection 
Data collection will consist of data collection worksheets. All information collected about 
subjects during the study will be kept strictly confidential and will be maintained in a secure, 
locked file and accessed only by study staff. Data will be entered into a secured, password 
protected database. Upon completion of the study, records will be archived in a password-
protected file on a Metis server. Subject names will not appear in any reports or published 
articles.  
 
Subjects will be assigned and identified by a sequential study number to protect the 
confidentiality of the subject. All information collected about subjects during the study will be 
kept strictly confidential. Subject names will not appear in any reports or published articles. 
Materials that identify subjects as individuals including medical records will not be released 
without the subject’s explicit permission as required by law. 
 
Subjects will be made aware that their medical records, which identify them as individuals, may 
be inspected by the designated IRB and/or other applicable regulatory authorities. 
 
Data Analysis 
All pertinent data will be analyzed using descriptive and correlational statistics as appropriate to 
compare those patients who were treated.  Overall standard descriptive statistical methods will be 
used to analyze other data; any categorical variables will be compared via chi square analysis 
while continuous variables will be compared via student-t test or Wilcoxson test as appropriate.  
We plan to perform a forward stepwise logistic regression. The available data including patient 
specific data as well as treatment variables will first be evaluated using a univariate analysis for 
possible significant risk factors. These will then be analyzed using a multiple logistic regression 
analysis and tested for interaction. 
 
D1. RISK/ SAFETY INFORMATION 
 
Risks of harm, measures to reduce the risks of harm and benefits of participation 
 
Risks of Harm   
Research Procedure Name: Application of NP-PWD or Wound VAC 
Research Procedure Description:  Application of a NP-PWD or Wound VAC onto open 
wound. 
 
 Research-related Risks   
•Itching, swelling and redness.  
•Infection.  

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•Poor healing.   
 
Measures to Minimize Risks of Harm: (Precautions, safeguards):  Application of the NP-
PWD or Wound VAC will be performed in a controlled clinical setting. Throughout the 
course of the study, the NP-PWD or Wound VAC will only be applied by trained 
professionals and the site will be monitored for signs adverse reactions such as infection or 
poor healing.   
 
D2. MONITORING AND REPORTING OF ADVERSE EVENTS/ SERIOUS ADVERSE 
EVENTS 
 
Monitoring 
Data collected on the subjects will be entered into a data spreadsheet that will be verified 
routinely by designated study personnel for accuracy and completeness. The study will be 
conducted in compliance with any applicable laws and regulations. Designated study staff, 
for accuracy and completeness, will verify data collected. All regulatory and subject files will 
be maintained in accordance with any applicable regulations. 
 
The principal investigator will be responsible for the protocol safety monitoring.  The PI will 
make study documents (e.g., consent forms, data pulls) and pertinent hospital or clinical 
records readily available for inspection by the IRB and oversight staff for confirmation of the 
study data. 
 
Adverse Events 
Adverse events that are anticipated in this patient population include those associated with 
wound healing.  
  
Unexpected adverse events and unanticipated problems 
All unanticipated problems involving risks to subject or others will be promptly reported to 
the IRB by email. A complete written report will follow the initial notification.  
 
Adverse Device Effects 
Unanticipated adverse device effects (UADE) are any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death, was not previously identified in a nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects.  
 

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UADEs must be reported by the clinical investigator to the sponsor and the reviewing IRB. 
For device studies, investigators are required to submit a report of a UADE to the sponsor 
and the reviewing IRB as soon as possible, but in no event later than 10 working days after 
the investigator first learns of the event (21 CFR 812.150(a)(1). Sponsors must immediately 
conduct an evaluation of a UADE and must report the results of the evaluation to FDA, all 
reviewing IRBs, and participating investigators within 10 working days after the sponsor first 
receives notice of the effect (21 CFR 812.46(b), 812.150(b)(1). 
 
D3. CONFEDENTIALITY  
 
PRIVACY FOR SUBJECTS   
Discussion of the study with the potential subject and the Informed consent process will be 
done in a quiet and private area of the hospital to ensure privacy.   
 
 
Subjects will be made aware that their research records, which identify them as individuals, 
may be inspected by applicable regulatory authorities, to ensure the integrity of the data 
and/or to protect research participants.   
 
CONFIDENTIALITY PROCEDURES FOR RESEARCH RECORDS, DATA  
To protect subject confidentiality, subjects will be identified using an assigned study ID 
number that will be used on study documents. The key linking subjects’ identities will be 
electronically stored by the research team on a password protected secured database, separate 
from other study data. All information collected about subjects during the study will be kept 
strictly confidential and will be maintained in a secure, locked file accessible only by study 
staff. Signed informed consent forms will be kept no fewer than three years, and no fewer 
than 6 years for signed HIPAA authorizations. Upon completion of the study, records will be 
archived in a password-protected file on an ISR network server. Thereafter, the key linking 
subject identifiers to study ID numbers will be destroyed, rendering the data permanently de-
identified. Subject names will not appear in any reports or published articles. 
 
 
Electronic data to include, but not limited to, information gathered from the electronic 
medical records and stored data entries will be stored on a password protected file. Locked 
subject study records will only be accessed by research personnel assigned to the protocol. 
 
D4. INTENDED USE OF DATA 
 
The data collected for this study will be used to determine the feasibility of the NP-PWD use as 
compared to SOC in the treatment of complex wounds. The intentions are to present the findings 
at a professional conference/meeting and/or via publication. All data presented or published will 
be de-identified keeping the identity of the subjects will be protected.