Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04543240
Status:
UNKNOWN
Last Update Posted:
2020-09-11
First Post:
2020-09-01
Brief Title:
Bacterial Load for Integra in Operative Wounds
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
The Relationship Between Bacterial Load and the Clinical Outcomes for Integra in Operative Wounds
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
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:
Proportion of postoperative complications infections dehiscence graft slough after initial application of Integra
Detailed Description:
This is a study examining the use of Integra for the treatment of lower extremity wounds to better understand the relationship between bacteria contamination levels and post-operative complications Wounds requiring operative application of Integra alone or Integra followed by a planned subsequent application of a STSG will be enrolled into this study
The tolerance of Integra to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts qualitative culture results and bacterial and wound protease levels at the time of Integra alone application or Integra followed by STSG application
Patients will then be followed until complete healing has occurred or until 16 weeks whichever comes first
The tolerance of Integra to bacterial bioburden at the time of application will be determined by observing their respective postoperative wound complications and correlating these findings with quantitative bacterial counts qualitative culture results and bacterial and wound protease levels at the time of Integra alone application or Integra followed by STSG application
Patients will then be followed until complete healing has occurred or until 16 weeks whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None