Bacterial Load for Integra™ in Operative Wounds

NCT04543240 | Unknown FDA Device

• 1 other identifier: 2017-0908
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wounds and Injuries

Keywords

Lower extremity

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Integra™ dermal regeneration template DEVICE

Integra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be anyone who is experiencing partial or full thickness wounds, pressure ulcers, venous and diabetic ulcers, burns, and traumatic wounds.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Christopher Attinger, MD

  MedStar Georgetown University Hopsital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Spinelli

CONTACT

202.687.6974; bs1114@georgeotown.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of the Center for Wound Healing

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 10, 2020
• Study Start: December 14, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)