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Recruiting NCT07060495

RADA16 for Adult Tonsillectomy

Phase III Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RADA16 hydrogel.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Use of Novel Self-assembling RADA-16 Peptide Matrix to Decrease Postoperative Epistaxis for Tonsillectomy Surgeries

Overview

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.

Interventions

  • Device RADA16 hydrogel
    Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.

Primary outcome measures

  • Postoperative Pain [Time frame: From enrollment to post-operative day fifteen]
Secondary outcome measures (5)
  • Number of Participants with post-tonsillectomy hemorrhage who receive topical agents [Time frame: From enrollment to post-operative day fifteen]
  • Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room [Time frame: From enrollment to post-operative day fifteen]
  • Number of participants who require hospital readmission for post tonsillectomy hemorrhage management [Time frame: From enrollment to post-operative day fifteen]
  • Number of participants who require a rescue analgesic for management following tonsillectomy procedure [Time frame: From enrollment to post-operative day fifteen]
  • Days participants take to resume their regular diet post operation [Time frame: From enrollment to post-operative day fifteen]

Eligibility criteria

Inclusion criteria

Adults undergoing tonsillectomy (CPT codes)

Exclusion criteria

Patients undergoing adenoidectomy or uvulopalatopharyngoplasty in addition to tonsillectomy

Patients who have had prior tonsillectomy or tonsillotomy

Patient undergoing tonsillectomy with concern for malignancy

Patients who are on opioids chronically prior to surgery

Patients with an additional indication for pain management (i.e. unrelated to tonsillectomy)

Patients who have been diagnosed with a bleeding disorder or hematologic malignancy

Patients who are on anticoagulants

The following at-risk populations:

Anyone under age 18

Pregnant women

Prisoners

Adults unable to consent (anyone lacking capacity)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Cooperman Barnabas Medical Center — Livingston
  • University Hospital — Newark

Publications

  • Pynnonen M, Brinkmeier JV, Thorne MC, Chong LY, Burton MJ. Coblation versus other surgical techniques for tonsillectomy. Cochrane Database Syst Rev. 2017 Aug 22;8(8):CD004619. doi: 10.1002/14651858.CD004619.pub3. PMID 28828761
  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. PMID 23392233
  • Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757. PMID 30798778

Identifiers

NCT: NCT07060495 · Pro2024001000 · FP00039655

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗