Bacterial Load for Integra™ in Operative Wounds

• Conditions: Wounds and Injuries

• Registration Number: NCT04543240
• Lead Sponsor: Georgetown University

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.

Study Timeline

• Study Start: 2017-12-14
• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine a threshold in which Integra is tolerant to bacteria that yields positive results (healing). The investigators believe that this device is more tolerant to bacterial load then current perception.	1 year	Quantitative CFUs will be obtained by obtaining tissue from the wound at the time of debridement from otherwise discarded tissue. After tissue cultures are obtained and sent to a designated microbial lab for analysis. Tissue culture is to be obtained from the central aspect of the wound bed. These cultures will be processed and analyzed for research purposes. Qualitative cultures will be obtained as per SOC and sent to the local lab per customary fashion.; Qualitative bacterial protease and human inflammation protease indications will be obtained by sampling and testing two separate wound fluid swabs on investigational devices; WOUNDCHEKTM Bacterial Status and WOUNDCHEKTM Protease Status. Bacterial Status detects enzymes that are present when bacteria have become pathogenic while Protease Status detects enzymes present when the wound is in a chronically inflamed state. The tests will be obtained from Woundchek Labs.

Trial Locations

Locations (1)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States