Incisions, Surgical
Conditions
Brief summary
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
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.
Interventions
DEVICENP-PWD
Application of NP-PWD device.
Sponsors
The Metis Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 18-85 years of age. 2. Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.
Exclusion criteria
1. Active infection as judged by the Investigator 2. Inability to give informed consent 3. Active malignant disease or subject is less than one year disease-free 4. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days 5. Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing 6. On any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study 7. Pregnant at enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related adverse events. | Three to six days post application. | 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. |
| Rate of successful application of the NP-PWD device | Three to fourteen days post application | Descriptive data collected: device application, device removal, adverse device effects, device errors, device complications, and resultant in healing status of the surgical incision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related adverse events. | Fourteen days post application. | 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. |
Countries
United States
Outcome results
None listed