Obtaining and Storing Blood Samples and Debridement Samples for Wound Related Research



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2007
End Date:April 2012

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The intent of this protocol is to obtain blood samples from subjects with or without a
wound, so the blood can be used in wound-related scientific studies. It is also the intent
of this protocol to salvage debrided wound material that is normally destined for
destruction, so it can be used in wound-related scientific studies.

The samples will be studied in order to attempt to better understand wounds and their
associated barriers to healing. Analytical methods used to examine the blood or debridement
can investigate morphological, molecular, immunological, cellular, viral, biochemical,
chemical, genetic, and/or transcriptional components of the samples. It is the goal of this
study to determine if these tests may be able to provide important insights into the keys of
wound healing, wound persistence, or wound deterioration.

Inclusion Criteria:

Inclusion Criteria for the Collection of Wound Debridement

1. The subject must have a full thickness wound.

2. The subject must be a candidate for sharp debridement.

3. The subject must be 18 years of age or older.

4. The subject must be mentally competent as determined by the Investigator Inclusion
Criteria for the Collection of Blood

Wounded or Otherwise Not Healthy Subjects, Subjects Weighing Less Than 110 lbs., or
Subjects Contributing 50ml of Blood or Less:

1. The subject must be 18 years of age or older.

2. The subject must be mentally competent as determined by the Investigator.

Not Wounded and Healthy Subjects Weighing at Least 110 lbs. Who May Contribute Up To 500ml
of Blood:

1. The subject must be 18 years of age or older.

2. The subject must be mentally competent as determined by the Investigator.

3. The subject must weigh at least 110 lbs.

4. The subject must have a hemoglobin level that is in or above the normal range within
the last 8 (eight) weeks as determined by standard clinical laboratory testing, the
copper sulfate test, or a point of care instrument.

Exclusion Criteria:

Exclusion Criteria for the Collection of Wound Debridement and Blood Collection*

1. The subject must not be currently incarcerated or pregnant.

2. The subject must not weigh less than 40 lbs.

3. If the subject will be contributing more that 50 ml of blood during an 8 (eight) week
period, then the subject must not have donated red blood cells within the last 8
(eight) weeks.
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