Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding
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|ClinicalTrials.gov Identifier: NCT00945412|
Recruitment Status : Withdrawn (PI moving to another institution)
First Posted : July 24, 2009
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Disorder Obstructive Sleep Apnea Tonsillar Hypertrophy||Device: Micropolysaccharide Hemospheres (Arista) Device: Electrocautery (Monopolar suction cautery)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Topical Microporous Polysaccharide Hemospheres Versus Electrocautery for Control of Pediatric Post-Tonsillectomy Bleeding|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||September 2011|
|Experimental: Micropolysaccharide Hemospheres (MPH)||
Device: Micropolysaccharide Hemospheres (Arista)
MPH is applied as an aerosolized powder which is applied to the bleeding fossa, immediately after suctioning the freshly completed tonsillotomy site to expose the tonsil bed. A separate aerosolizer is used for each patient in order to maximize uniformity per standard dose applied. Each initial dose remains in situ for up to 60 seconds in an attempt to achieve complete hemostasis with a single dose. (Prior data from MPH use has shown that 30-60 seconds is the time typically required for hemostasis for diffuse, non-arterial bleeds.) If there is persistent bleeding after this timeframe, then the bed is irrigated and suctioned and a second equivalent dose is applied.
No pressure pack and no oxymetazoline or other topical vasoconstrictor is applied in either group during these initial hemostatic steps, since they are potential confounders of hemostatic effect.
Other Name: Arista
|Active Comparator: Electrocautery||
Device: Electrocautery (Monopolar suction cautery)
Monopolar suction electrocautery is used at 20 Watts. Cautery is applied with a light surface touch until bleeding has stopped. In addition, any prominent visible vessels are cauterized.
Other Name: Monopolar suction cautery
- Primary outcome measure: Adequacy of intraoperative hemostasis, as evaluated by the following metrics: 1. Requirement for rescue hemostasis. 2. Time to complete hemostasis. [ Time Frame: 0-14 days postoperatively ]
- The main secondary outcome measure is the number of patients with adverse events. These adverse events are expected to occur in the following forms: postoperative primary hemorrhage, postoperative secondary hemorrhage, and severe postoperative pain. [ Time Frame: 0-14 days postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945412
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Michael J Cunningham, MD||Massachusetts Eye and Ear Infirmary|