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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NP-PWD application | Experimental | All patients enrolled into the study will have the negative pressure- platform wound device applied to their surgical incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NP-PWD | Device | Application of NP-PWD device. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Baptist | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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