Recruiting

Integra™

Sponsor:

Georgetown University

Code:

NCT04543240

Conditions

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Integra™ dermal regeneration template

Study Details

Brief summary:

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

Conditions

Wounds and Injuries

Study ID

NCT04543240

Start date

Dec 14, 2017

Status verified date

Sep, 2020

Completion date

Jan 1, 2021

Anticipated

Primary completion date

Jan 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

54 participants

Anticipated

Interventions and Outcome Measures

Interventions

Integra™ dermal regeneration template

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

Primary outcome measure

  • 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. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Brittany Spinelli

202.687.6974bs1114@georgeotown.edu

Locations

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Priscilla Wong

202-444-1321pw504@georgetown.edu

More Information

Sponsor

Georgetown University

Last update posted

Sep 11, 2020

Last verified

Sep, 2020

Keywords

  • Lower extremity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2020-09-11.