Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552481
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
A Case-Control Study of Negative Pressure Platform Wound Devices NP-PWD for Skin and Soft Tissue Defects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Case-Control Study of Negative Pressure Platform Wound Devices NP-PWD for Skin and Soft Tissue Defects
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NP-PWD2
Brief Summary:
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
Detailed Description:
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 changeremoval 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None