Bacterial Load for Integra™ in Operative Wounds

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543240
• Other study ID #: 2017-0908
• Status: Recruiting
• Start date: December 14, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: September 2020
• Source: Georgetown University
• Contact: Brittany Spinelli
• Phone: 202.687.6974
• Email: bs1114[@]georgeotown.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound
• Wounds and Injuries

Intervention

Device:
• Integra™ dermal regeneration template
Integra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone

Locations

Country	Name	City	State
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Integra

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 year