Bacterial Load for Integra™ in Operative Wounds

Last updated: September 9, 2020
Sponsor: Georgetown University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT04543240
2017-0908
  • Ages 18-90
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofIntegra™.

  • Patients able and willing to comply with the study protocol.

Exclusion

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 applicationof Integra™.

  • Patients that are not able or willing to comply with the study protocol.

Study Design

Total Participants: 54
Study Start date:
December 14, 2017
Estimated Completion Date:
January 01, 2021

Study 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.

Connect with a study center

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

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