Trial Outcomes & Findings for Effect of Bupivacaine-infused Fibrin Sealant Application on Post-tonsillectomy Pain & Hemorrhage (NCT NCT02343263)

Last Updated: 2018-08-10

Results Overview

Tonsillectomy (and adenotonsillectomy) are associated with a 3-5% postoperative hemorrhage risk from the tonsillectomy wound beds across the United States; our institution has a calculated average of between 4% - 5%. Parents will be contacted 2 to 3 weeks following their procedure and inquiries about post-operative bleeding will be made. Bleeding \>1 tablespoon or that requires A) presentation to an emergency department, B) admission to a hospital, or C) return to the operating room will be considered significant post-operative hemorrhage. Distinction will also be made between early (\<24 hours after surgery) and late (\>24 hours after surgery) postoperative bleeding. The bleeding risk after 2 weeks from surgery is exceedingly small. No prior studies have identified any increased risk with utilizing either fibrin sealant or bupivacaine. This study will evaluate whether the intervention reduces bleeding risk.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

14 days

Results posted on

2018-08-10

Participant Flow

Study closed due for administrative reasons

Study closed due for administrative reasons. Subjects fell out of study due to a number of reasons, including receiving a laser supraglottoplasty which was an exclusion criteria. Also, failure to complete study. Also our IRB later required a FDA IND which we did not obtain, so study was stopped

Participant milestones

Participant milestones
Measure	Control Arm Control Arm did not receive any Fibrin sealant nor Bupivacaine	Fibrin Sealant Alone Fibrin Sealant Alone- subjects received only fibrin sealant to tonsillar fossa	Bupivacaine-infused Fibrin Sealant Bupivacaine-infused Fibrin Sealant was placed in tonsillar fossa of subjects
Overall Study STARTED	5	3	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Arm Control Arm did not receive any Fibrin sealant nor Bupivacaine	Fibrin Sealant Alone Fibrin Sealant Alone- subjects received only fibrin sealant to tonsillar fossa	Bupivacaine-infused Fibrin Sealant Bupivacaine-infused Fibrin Sealant was placed in tonsillar fossa of subjects
Overall Study Physician Decision	5	3	1

Baseline Characteristics

Effect of Bupivacaine-infused Fibrin Sealant Application on Post-tonsillectomy Pain & Hemorrhage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=5 Participants 44 patients will be randomized to receive no topical treatment to their tonsillectomy (or adenotonsillectomy) wound bed as is the current standard of care at our institution. The wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis alone.	Fibrin Sealant Alone n=3 Participants 44 patients will be randomized to receive application of topical fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis. Fibrin Sealant: Fibrin sealant will be applied to the wound bed topically as per product instructions.	Bupivacaine-infused Fibrin Sealant n=1 Participants 44 patients will be randomized to receive application of topical bupivacaine-infused fibrin sealant to their tonsillectomy (or adenotonsillectomy) wound bed to assess the pain reduction benefits of fibrin sealant alone. Prior to application of fibrin sealant, the wound bed will be treated with instrumentation in the operating room to ensure adequate hemostasis. Bupivacaine: 1 milliliter (mL) of 0.75% Bupivacaine Hydrochloride will be infused into 4mL of fibrin sealant (diluting the Bupivacaine HCl to 0.15%). The bupivacaine-infused fibrin sealant will then be applied to the tonsillectomy (or adenotonsillectomy) wound bed.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	6.2 years STANDARD_DEVIATION 1.8 • n=5 Participants	3.7 years STANDARD_DEVIATION 2.9 • n=7 Participants	8 years STANDARD_DEVIATION 0 • n=5 Participants	5.6 years STANDARD_DEVIATION 2.3 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
study closed for administrative reasons	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Data not collected