A synthetic haemostatic agent (PuraStat) for endonasal surgery

Phase 4

• Conditions: asal obstruction; Nasal obstruction; Surgery - Surgical techniques; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620001266954
• Lead Sponsor: RPA Institute of Academic Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-25
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Participants must meet all of the following criteria:
1. Patients suffering from a condition requiring endoscopic nasal turbinate reduction either by powered submucosal resection or turbinectomy
2. Patients undergoing a bilateral and symmetrical surgery

Exclusion Criteria

Participants must not meet any of the following criteria:
1. Patients undergoing an asymmetrical or unilateral procedure
2. Patients undergoing a medial maxillectomy
3. Patients on anticoagulation or dual antiplatelet therapy
4. Patients with known coagulation system disorders
5. Patients suffering from spontaneous nasal bleeding
6. Patients with intra-operative arterial bleeding
7. Patients believed to have an allergic response to RADA 16 or oxidised regenerated cellulose

Patients who required return to theatre and further haemostasis to a site where PuraStat was applied in the first 24 hours will be excluded from the study population for secondary endpoint comparison

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital recorded or participant-reported bleeding events in the first 24 hours post-operatively<br><br>Grading scale (significant bleeding if 2+)::<br>0: No bleeding or bleeding settling without intervention<br>1: Bleeding settling with digital pressure or topical decongestant sprays<br>2: Bleeding requiring bedside cautery or further topical haemostats<br>3. Bleeding requiring prolonged tamponade<br>4: Bleeding requiring return to theatre[Up to 24 hours post-operatively (inpatient and outpatient)]

Secondary Outcome Measures

Name	Time	Method
Patient-reported bleeding events from 24 hours post-operatively to 6 weeks post-operatively<br><br>Grading scale (significant bleeding if 2+)::<br>0: No bleeding or bleeding settling without intervention<br>1: Bleeding settling with digital pressure or topical decongestant sprays<br>2: Bleeding requiring bedside cautery or further topical haemostats<br>3. Bleeding requiring prolonged tamponade<br>4: Bleeding requiring return to theatre[Standardised 6 week follow-up];Severity of crusting by endoscopic evaluation<br><br>Grading scale:<br>0: Absent<br>1: Minimal<br>2: Moderate<br>3: Abundant[Standardised 6 week follow-up];Proportion of patients requiring antibiotics or with evidence of active local infection[Standardised 6 week follow-up]