Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04762732
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2021-02-17
Brief Title:
The Use of iNPWT for Management of ALT Flap Donor Site Wound
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Use of Incisional Negative Pressure Wound Therapy for Management of Anterolateral Thigh Flap Donor Site Wound A Prospective Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap ALT is associated with significant morbidity Incisional negative pressure wound therapy NPWT may decrease complications in high-risk incisions Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study but no prospective study of NPWT application in the ALT flap donor site has been reported This study aims to assess the incidence of complications at ALT flap donor site with an incisional NPWT device PREVENA A prospective controlled pair-matched study has been designed to compare the effectiveness complication rate and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing
Detailed Description:
Primary closure or skin grafting of the donor site after harvest of a anterolateral thigh flap ALT is associated with significant morbidity Incisional negative pressure wound therapy NPWT may decrease complications in high-risk incisions Successful use of NPWT has been reported in the treatment of ALT flap donor site wounds in a retrospective observational study but no prospective study of NPWT application in the ALT flap donor site has been reported This study aims to assessed the incidence of complications at ALT flap donor site with an incisional NPWT device PREVENA A prospective controlled pair-matched study has been designed to compare the effectiveness complication rate and scar quality of ALT flap donor site between using incisional NPWT and conventional bolster dressing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None