Topical haemostatic agent Arista* AH compared to nasal packing following turbinate surgery: a prospective randomised controlled trial.

Recruiting

• Conditions: nasal turbinate reduction; Turbinate surgery; 10019190

• Registration Number: NL-OMON51310
• Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 118

Inclusion Criteria

1. Adult patients aged >= 16 years
2. Scheduled for bilateral inferior turbinate surgery, with or without nasal
septal surgery
3. Written informed consent

Exclusion Criteria

1. Turbinate surgery combined with rhinoplasty and/or endoscopic sinus surgery
2. Nasal polyps
3. Use of anticoagulants
4. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this study is to measure the amount of patient discomfort following<br /><br>turbinate surgery in the intervention group, treated with Arista* AH, compared<br /><br>to the control group, treated with non-absorbable Merocel® nasal packing. This<br /><br>will be measured by means of the Nasal Obstruction Symptom Evaluation (NOSE)<br /><br>scale and four questions on a Visual Analogue Scale (VAS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary aim of this study is to investigate the effects of Arista* AH on<br /><br>preventing excessive postoperative nasal bleeding, by calculating the<br /><br>percentage of excessive postoperative bleedings in the intervention group<br /><br>treated with Arista* AH versus the control group treated with non-absorbable<br /><br>Merocel® nasal packing.</p><br>