A Case Series Study of Negative Pressure Platform Wound Device

Study Overview
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Brief Summary
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This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the NPWT capability for future use in more tenuous situations of wound closure.

Detailed Description
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A case series study of 10 subjects will be conducted by enrolling patients who are scheduled for elective surgical incisions. Patients will be screened for inclusion criteria and asked to consent to participate in the study for single application treatment with the NP-PWD for 3-6 days. Initial evaluation of the incision would occur on Day 0, including screening, pre-procedure evaluation, measurement and photography of the closed surgical incision. Follow up data is then gathered Day 3-6 with removal of the NP-PWD, surgical incision assessment and photography, and assessment for adverse effects. Day 9-14 follow up include the same assessments of progression of wound closure. Gathered clinical data of the 10 subjects will be used to evaluate the safety in using the NPWT device for effective wound healing.

Official Title
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A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD) on the Healing of Elective Surgical Incisions

Conditions
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Incisions, Surgical

Intervention / Treatment
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* Device: NP-PWD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18-85 years of age. Scheduled for surgical intervention in which an incision will be made and skin closure will be performed. Exclusion Criteria: Active infection as judged by the Investigator Inability to give informed consent Active malignant disease or subject is less than one year disease-free Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing On any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study Pregnant at enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NP-PWD application<br>All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision. | Device: NP-PWD<br>* Application of NP-PWD device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related adverse events. | Safety is assessed by recording each adverse event (AE) occurring during the period the patient has the study device applied and throughout the entire enrollment period. | Three to six days post application. | 
| Rate of successful application of the NP-PWD device | Descriptive data collected: device application, device removal, adverse device effects, device errors, device complications, and resultant in healing status of the surgical incision. | Three to fourteen days post application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related adverse events. | Safety is assessed by recording each adverse event (AE) occurring during the period the patient has the study device applied and throughout the entire enrollment period. | Fourteen days post application. |