Bacterial Load for Integra™ in Operative Wounds

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04543240
Study type	Observational [Patient Registry]
Source	Georgetown University
Contact	Brittany Spinelli
Phone	202.687.6974
Email	bs1114@georgeotown.edu
Status	Recruiting
Phase
Start date	December 14, 2017
Completion date	January 1, 2021

View Details

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