NCT04543240

Bacterial Load for Integra™ in Operative Wounds

The Relationship Between Bacterial Load and the Clinical Outcomes for Integra™ in Operative Wounds

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 54 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
DEVICE	Integra™ dermal regeneration template	Integra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone

Timeline

• Start date: 2017-12-14
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2020-09-10
• Last updated: 2020-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study