Bacterial Load for Integra™ in Operative Wounds

Georgetown University

Status: Unknown

Conditions: Wounds and Injuries

Treatments: Device: Integra™ dermal regeneration template

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04543240

2017-0908

Details and patient eligibility

About

Proportion of postoperative complications (infections, dehiscence, graft slough) after initial application of Integra™

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female age 18-90.
• Full-thickness wounds below the knee.
• Patients who require, in the opinion of the Investigator, operative application of Integra™.
• Patients able and willing to comply with the study protocol.

Exclusion criteria

• Male or Female under 18 or over 90
• Patients that do not have Full-thickness wounds below the knee
• Patients who do not require, in the opinion of the Investigator, operative application of Integra™.
• Patients that are not able or willing to comply with the study protocol.