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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51310
Enrollment
118
Registered
2022-12-12
Start date
2023-01-06
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasal turbinate reduction Turbinate surgery

Interventions

At the end of the procedure for turbinate surgery, the control group will receive the standard treatment of non-absorbable Merocel® nasal packing, whereas the intervention group will be treated with

Sponsors

Medisch Centrum Leeuwarden
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
The secondary aim of this study is to investigate the effects of Arista* AH on preventing excessive postoperative nasal bleeding, by calculating the percentage of excessive postoperative bleedings in the intervention group treated with Arista* AH versus the control group treated with non-absorbable Merocel® nasal packing.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)