Chitosan Endoluminal Hemostatic Dressing

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$226,185.00
Award Year:
2009
Program:
STTR
Phase:
Phase I
Contract:
1R41DK078400-01A2
Award Id:
93686
Agency Tracking Number:
DK078400
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
HEMCON, INC., 10575 SW CASCADE AVE, STE 130, PORTLAND, OR, 97223
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
116661344
Principal Investigator:
HUAXIE
(503) 216-6826
HUA.XIE@PROVIDENCE.ORG
Business Contact:
MICHELLESELLS
() -
Research Institute:
PROVIDENCE HEALTH SYSTEM- -BRAIN INST

PROVIDENCE HEALTH SYSTEM- -BRAIN INST
10150 SE 32ND AVE
PORTLAND, OR, 97222 6516

Domestic nonprofit research organization
Abstract
DESCRIPTION (provided by applicant): HemCon, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Summary Abstract P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Abstract The goal of this proposal is to demonstrate Phase I feasibility of a chitosa n endoluminal hemostatic dressing (CEHD) that can be delivered through a Foley catheter to control and prevent urethral bleeding in a swine model. This swine model is a model of efficacy of blocking hemorrhage associated with transurethral resection of the prostate (TURP). TURP is the first line surgical treatment for benign prostate hyperplasia (BPH). TURP is performed about 100,000 times per year in the US. Post-operative hemorrhage after TURP is one of the major causes of prolonged catheterization and ho spitalization, occurring in 6-10% of patients. Our device will be used to place a relatively inexpensive proprietary bandage via the catheter to prevent prolonged bleeding. This would allow for early catheter removal, improved patient comfort, accelerated recovery and significantly reduced hospital costs due to shorter hospital stays. Proprietary chitosan based dressings have been developed by HemCon and are FDA approved for controlling hemorrhage, especially on the battlefield. We have adapted the HemCon d ressing as the CEHD to enable it to be used to control bleeding and facilitate surgery in the TURP procedure. Modifications to the HemCon dressing have been reduction in wall thickness (from 1.2 mm to ~200 ltm) and improvement in resistance to dissolution. In this Phase I proposal we will: i) further refine the CEHD so that it can be applied by a Foley catheter to the resected prostrate surface to stay in place for up to 72 hours to control blood flow in the presence of urine; and ii) test the efficacy of t he bandage by comparing severity and duration of hematouria in the swine model of TURP. Feasibility criteria in this study will be: i) the CEHD demonstrates significantly reduced bleeding in the first 24 hours compared to current standard of practice; ii) there is no significant enhancement in injury infection or inflammation in the CEHD group compared to standard of practice; iii) the CEHD can be removed by dissolution with a low pH irrigation solution. Phase II studies will lead to an FDA submission for c linical trials. PUBLIC HEALTH RELEVANCE: HemCon Medical Technologies, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Narrative P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Project Narrative Bleeding from prostatic cavity is the maj or complication in resection of enlarged prostatic gland tissue for the treatment of benign prostatic hyperplasia (BPH). Prolonged urethral catheterization due to significant post-operative bleeding mostly causes discomfort of the patients and increases th e risk of urinary infection and other chronic complications. The motivation of this project, based upon our successful prototype of chitosan hemostatic dressing, is to develop an innovative endoluminal chitosan hemostatic dressing to control and prevent th e prostatic bleeding and shorten the catheterization time after prostatic surgery. Our long-term goal is to provide a safe, effective and convenient technique to treat and prevent the bleeding from prostatic surgeries.

* information listed above is at the time of submission.

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