RADA16 for Adult Tonsillectomy

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain

• Registration Number: NCT07060495
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following tonsillectomy procedures.

Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.

Participants will:

* Undergo tonsillectomy procedure.

* Receive and fill out a survey sent via email every 2 days following their procedure for 15 days and track their symptoms.

Detailed Description

This is a prospective study evaluating the impact of intraoperative RADA16 application on the postoperative course following tonsillectomy as it relates to pain, bleeding, readmission, and use of a rescue analgesic (ex., oxycodone). We propose a randomized controlled trial whereby patients undergoing tonsillectomy would either receive a standard analgesic regimen (postoperative acetaminophen and NSAIDs plus oxycodone as a supplemental analgesic) versus intraoperative RADA16 application plus a standard analgesic regimen.

Study Timeline

• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-07-01
• Study First Posted: 2025-07-11
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-21
• Study Start: 2025-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	From enrollment to post-operative day fifteen	Pain assessed via the pain visual analog scale (VAS). The primary outcome measure will be assessed via online survey on post-operative day one then subsequently every other day until post-operative day fifteen.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with post-tonsillectomy hemorrhage who receive topical agents	From enrollment to post-operative day fifteen	Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage
Days participants take to resume their regular diet post operation	From enrollment to post-operative day fifteen	Recording how many days it takes for participants to return to their regular diet post operation
Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room	From enrollment to post-operative day fifteen	Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage
Number of participants who require hospital readmission for post tonsillectomy hemorrhage management	From enrollment to post-operative day fifteen	Number of participants who require readmission for management of post tonsillectomy hemorrhage
Number of participants who require a rescue analgesic for management following tonsillectomy procedure	From enrollment to post-operative day fifteen	Number of participants who use a rescue analgesic following their tonsillectomy procedure