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Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding

Obstructive Sleep Apnea Clinical Trial

Official title:
Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding

Clinical Trial Summary

The ultimate goal of this work is to establish a method for control bleeding after tonsillectomy in awake children. Treatment of post-tonsillectomy bleeding in children typically requires general anesthesia with currently used electrocautery techniques. Micropolysaccharide hemosphere technology is a unique absorbable agent that helps clot form. These hemospheres consist of 100% purified plant starch that enhances natural clotting by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a gelled matrix. This device provides painless, non-irritating control of bleeding, and has been used effectively for control of nosebleeds in awake adult patients. This device, however, has not been tested in the tonsillar fossae in children; thus, this study is performed to determine if at least 50% of children with bleeding tonsillar fossae can be spared rescue treatment with electrocautery.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00945412
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact
Status Withdrawn
Phase Phase 3
Start date July 2009
Completion date September 2011
View Details
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