A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD)
A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD) on the Healing of Elective Surgical Incisions
Sponsor: The Metis Foundation
Listed as NCT04080011, this NA trial focuses on Incisions, Surgical and remains completed. Sponsored by The Metis Foundation, it has been updated 6 times since 2019, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Mar 2021 — Jul 2024 [monthly]
Completed NA
Status: Recruiting → Completed
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Jan 2021 — Mar 2021 [monthly]
Recruiting NA
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Feb 2020 — Jan 2021 [monthly]
Recruiting NA
▶ Show 1 earlier version
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Oct 2019 — Feb 2020 [monthly]
Recruiting NA
First recorded
Aug 2019
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- The Metis Foundation
For direct contact, visit the study record on ClinicalTrials.gov .