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Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay

NCT ID: NCT01750203

Last Updated: 2012-12-20

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

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2012-12-31

Brief Summary

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The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.

Detailed Description

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Conditions

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Chronic Wounds With Different Etiologies

Keywords

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Diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds

Study Groups

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No treatment

No cohort as this study is not using a treatment or intervention only swabs are being collected.

Swabs

Intervention Type OTHER

There is no intervention only swabs are being used to collect wound fluid samples

Interventions

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Swabs

There is no intervention only swabs are being used to collect wound fluid samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection);
* Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection.
* Subject is 18 years of age or older.
* Subject agrees to complete all aspects of the study and provides Informed Consent

Exclusion Criteria

* Subject is less than 18 years of age.
* Target wound contains a malignancy
* Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
* Subject is confirmed to be positive for HIV or hepatitis.
* Subject is unable or unwilling to provide informed consent.
* Subjects deemed inappropriate for the study by the site's Principal Investigator.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Systagenix Wound Management

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Serena, MD

Role: PRINCIPAL_INVESTIGATOR

SerenaGroup, Inc.

Locations

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St. John Wound Center

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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Systagenix

Identifier Type: OTHER

Identifier Source: secondary_id

SBIR-001-A

Identifier Type: -

Identifier Source: org_study_id