Bacterial Load for Integra™ in Operative Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-14

Study Completion Date

2021-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Wounds and Injuries

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Integra™ dermal regeneration template

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No