Triamcinolone Packing Following Endoscopic Sinus Surgery

July 27, 2023 updated by: Marilene Wang, University of California, Los Angeles

Randomized Controlled Trial of Triamcinolone Impregnated Hemostatic Bioabsorbable Middle Meatus Nasal Packing Following Endoscopic Sinus Surgery

Endoscopic sinus surgery (ESS) is a well-established treatment strategy for medically refractory chronic rhinosinusitis. Middle meatus spacers are currently used following ESS to prevent scarring, synechiae formation, and middle turbinate lateralization. A 2012 systematic review favored spacers compared to no spacers, with a follow up 2013 systematic review finding no difference between the use of absorbable and non-absorbable spacers. This review, however, noted that steroidal spacers may reduce middle meatus scarring and adhesions. More recent data has shown the effectiveness of steroid releasing middle meatus implants in preventing middle turbinate lateralization, reducing synechiae formation, and reducing revision surgery. However, these stents are costly, and may result in excess crusting postoperatively, which limits their use in some settings. Another study investigated the use of steroid-impregnated absorbable packing materials, and demonstrated the safety and utility of this method of middle meatus packing. However, a limitation to this study was overall low enrollment with only 19 total patients enrolled.

The purpose of this project is to add to the existing body of evidence regarding middle meatus spacers, by studying the impact of steroid impregnated, bioabsorbable hemostatic packing (Hemopore®, Stryker) on postoperative visualization and scar formation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction

Endoscopic sinus surgery (ESS) is a well-established treatment strategy for medically refractory chronic rhinosinusitis. Middle meatus spacers are currently used following ESS to prevent scarring, synechiae formation, and middle turbinate lateralization. A 2012 systematic review favored spacers compared to no spacers, with a follow up 2013 systematic review finding no difference between the use of absorbable and non-absorbable spacers. This review, however, noted that steroidal spacers may reduce middle meatus scarring and adhesions. More recent data has shown the effectiveness of steroid releasing middle meatus implants in preventing middle turbinate lateralization, reducing synechiae formation, and reducing revision surgery. However, these stents are costly, and may result in excess crusting postoperatively, which limits their use in some settings. Another study investigated the use of steroid-impregnated absorbable packing materials, and demonstrated the safety and utility of this method of middle meatus packing. However, a limitation to this study was overall low enrollment with only 19 total patients enrolled.

The purpose of this project is to add to the existing body of evidence regarding middle meatus spacers, by studying the impact of steroid impregnated, bioabsorbable hemostatic packing (Hemopore®, Stryker) on postoperative visualization and scar formation.

Research Design The proposed study will be a randomized controlled trial comparing steroid impregnated bioabsorbable and dissolvable nasal packing to non-steroid impregnated packing. Potential subjects will be adults, aged 18 and older, with a diagnosis of chronic rhinosinusitis based on the 2016 International Consensus Statement on Allergy and Rhinology: Rhinosinusitis definition, who have failed a trial of previous medical therapy, have bilateral sinus disease on CT imaging, and will undergo bilateral endoscopic sinus surgery. If the patient chooses to proceed with surgery for their medically refractory chronic rhinosinusitis they will be introduced to the research proposal and if willing to participate, the informed consent process will take place, during their preoperative visit. On the day of surgery the patient's right and left sinuses will be randomized to either steroid or no steroid middle meatus packing. At the end of the surgical procedure, the attending surgeon will soak the Hemopore in either 5 cc Duobiotic saline irrigation (bacitracin 50,000 units, polymyxin B 500,000 units in 0.9% sodium chloride 500mL) or 1 ml of triamcinolone 40 mg/ml (Kenalog-40, Bristol-Myers Squibb) mixed with 5 cc Duobiotic saline irrigation and label them 1 (no steroid) and 2 (steroid). The fellow or resident surgeon will then insert the packing into the middle meatus, with the steroid packing going into the side randomized for steroid, and the non-steroid packing going into the other side. A password protected data file will be maintained in UCLA Box, accessible to the investigators, where the side of placement of the packing will be recorded. Postoperative visits will be scheduled at the usual time points: 7-10 days, 24-30 days, and 2-3 months post-op. Nasal endoscopy will be performed at each visit, as a standard post op procedure. Video recording of the endoscopy will be saved for review at the conclusion of the study for determination of the patency of the postop cavity using the Lund-Kennedy endoscopic scoring system (LKES) and the perioperative sinus endoscopy (POSE) score . Symptom scores will also be collected and reviewed, as it is current practice for patients to respond to the sinonasal outcome test-22 (SNOT-22) at preop and postop visits. LKES and POSE scores will be recorded in a password protected file in UCLA Box that is separate from the file containing the side of steroid packing.

The investigators plan to enroll 50 consecutive patients in this study, over the course of about 4-6 months. At the end of the study period, the endoscopy scores (LKES and POSE) will be compared between the steroid and non-steroid sides. Each patient will serve as his/her own control. Statistical analysis will be performed using paired t tests for continuous variables and chi-square tests for categorical variables. A p value < 0.05 will be considered statistically significant.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over age 18 who have bilateral chronic sinusitis who have failed previous medical therapy and will undergo endoscopic sinus surgery

Description

Inclusion Criteria:

  • aged 18 and older
  • diagnosis of chronic rhinosinusitis based on the 2016 International Consensus Statement on Allergy and Rhinology: Rhinosinusitis definition
  • failed a trial of previous medical therapy
  • have bilateral sinus disease on CT imaging
  • will undergo bilateral endoscopic sinus surgery.

Exclusion Criteria:

  • unable to give informed consent
  • not a candidate for endoscopic sinus surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lund Kennedy Endoscopy score
Time Frame: 1 week
Assessment of inflammation, crusting, polyps, edema in sinus; Scale from 0 to 2, with higher scores meaning worse outcome
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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