Bacterial Load for Integra™ in Operative Wounds
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Wounds and Injuries
- Design
- Observational Model: Case-OnlyTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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 subsequen...
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.
Tracking Information
- NCT #
- NCT04543240
- Collaborators
- Integra LifeSciences Corporation
- Investigators
- Principal Investigator: Christopher Attinger, MD MedStar Georgetown University Hopsital