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Swab Sample Collection for the Detection of Bacterial Proteases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881815
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Systagenix Wound Management

Tracking Information
First Submitted Date June 11, 2013
First Posted Date June 20, 2013
Last Update Posted Date July 8, 2013
Study Start Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2013)
The determination of the protease levels in clinically infected and non infected chronic wounds from swabs by enzyme techniques. [ Time Frame: 3 days ]
Wound exudate (fluid) swab samples from different etiologies of wounds will be collected. Subjects who have wounds that do not show clinical signs of infection, as well as Subjects who have wounds that do show clinical signs of infection will be enrolled. a maximum of four (4) swab sample from Subjects from whom Informed Consent has been obtained. The swabs will be subjected to various tests methods that may include, but are not limited to, the following: 1) quantitative bacterial cultures (for aerobic and / or anaerobic bacteria), 2) "for research use only" testing on test formats currently in development by the sponsor (note: this data will not be used to support regulatory filings, such as CE marking or FDA submissions for U.S. market clearance), 3) molecular microbiology, and 4) protease analysis.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01881815 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 19, 2013)
to determine the bacteria present in infected and non infected wounds by microbiological techniques [ Time Frame: 3 days ]
The difference in the microbial flora will be determine by analysis of the swabs from infected and non infected wounds.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Swab Sample Collection for the Detection of Bacterial Proteases
Official Title Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
Brief Summary 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 Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Swabs will be tested on day on collection. Test is destructive. No swabs will be retained.
Sampling Method Non-Probability Sample
Study Population Adult subjects (greater than 18 years old), presenting at participating clinical sites with wounds of different etiologies, who are willing to provide informed consent and who meet the inclusion / exclusion criteria, will be prospectively enrolled
Condition Chronic Wounds
Intervention Other: Swabs
There is no intervention only swabs are being used to collect wound fluid samples
Study Groups/Cohorts No treatment
No cohort as this study is not using a treatment or intervention only swabs are being collected.
Intervention: Other: Swabs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 4, 2013)
141
Original Estimated Enrollment
 (submitted: June 19, 2013)
200
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01881815
Other Study ID Numbers SBIR-001-B
Systagenix ( Other Identifier: Systagenix )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Systagenix Wound Management
Study Sponsor Systagenix Wound Management
Collaborators Not Provided
Investigators
Principal Investigator: Tom Serena, MD SerenaGroup, Inc.
PRS Account Systagenix Wound Management
Verification Date June 2013