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| ID | Type | Description | Link |
|---|---|---|---|
| FP00039655 | Other Grant/Funding Number | 3-D Matrix |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RADA16 | Active Comparator | Patients randomized to the treatment arm will undergo 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. |
|
| Control arm | No Intervention | Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RADA16 hydrogel | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | 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. | From enrollment to post-operative day fifteen |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with post-tonsillectomy hemorrhage who receive topical agents | Number of Participants with post-tonsillectomy hemorrhage who receive topical agents for management of post tonsillectomy hemorrhage | From enrollment to post-operative day fifteen |
| Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room |
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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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wayne D Hsueh, MD | Contact | 973-972-4588 | wayne.hsueh@rutgers.edu | |
| Emily Kwon, BA | Contact | esk104@njms.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wayne D Hsueh, MD | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooperman Barnabas Medical Center | Recruiting | Livingston | New Jersey | 07039 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28828761 | Background | 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. | |
| 23392233 | Background | 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. |
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Determining if access to university data can be available for the study
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Number of Participants with post-tonsillectomy hemorrhage who require a return to the operating room for management of post tonsillectomy hemorrhage |
| From enrollment to post-operative day fifteen |
| Number of participants who require hospital readmission for post tonsillectomy hemorrhage management | Number of participants who require readmission for management of post tonsillectomy hemorrhage | From enrollment to post-operative day fifteen |
| Number of participants who require a rescue analgesic for management following tonsillectomy procedure | Number of participants who use a rescue analgesic following their tonsillectomy procedure | From enrollment to post-operative day fifteen |
| Days participants take to resume their regular diet post operation | Recording how many days it takes for participants to return to their regular diet post operation | From enrollment to post-operative day fifteen |
| University Hospital | Not yet recruiting | Newark | New Jersey | 07103 | United States |
|
| 30798778 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |