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

Postoperative nasal packing is common practise following turbinate surgery to
prevent excessive postoperative nasal bleeding. However, nasal packing often
has serious disadvantageous effects and causes patient discomfort, like nasal
obstruction, pressure in the head and/or headache, dyspnoea, disturbed sleep
and pain when removing the packing. Furthermore, the packing could cause
infections and mucosal lesions upon removal. The aim of this study is to
investigate the effects of the topical haemostatic device Arista* Absorbable
Haemostat (AH) on postoperative (dis)comfort and prevention of excessive
postoperative bleeding. The use of this haemostatic device could improve
regular patient care and decrease postoperative patient discomfort in the
future.

The main objective of this randomised controlled study is to investigate
whether patients treated with Arista* AH have less postoperative complaints
after inferior turbinate surgery compared to patients treated with
non-absorbable Merocel® nasal packing. The secondary objective is to
investigate the effects of Arista* AH on preventing excessive postoperative
nasal bleeding after inferior turbinate surgery compared to nasal packing.

An open, prospective, randomised controlled trial with two arms: the control
group with standard treatment of non-absorbable Merocel® nasal packing will be
compared to the intervention group, which will receive Arista* AH after
bilateral surgical reduction of the inferior turbinates.

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 Arista* AH.

Turbinate surgery is carried out following normal protocol for both the
intervention and control group. Patients who will be randomised into the
control group will be treated with non-absorbable Merocel® nasal packing and
will follow the normal protocol for postoperative management. Patients in the
intervention group will be treated with Arista* AH at the end of surgery, which
will not influence the duration of surgery. The intervention group will also
follow the standard postoperative protocol, without the need for removing any
nasal packing. Since Arista* AH is CE-marked and used within its intended
purpose, the expected risks are regarded as minimal. Theoretically, there might
be a slightly higher risk for a postoperative bleeding compared to the standard
treatment, however, this has not been shown in practice according to a pilot
study with ten patients treated with Arista* AH without any postoperative
bleeding.
The burden for both the intervention and control group is to complete
questionnaires at four different time points: just before surgery, three hours
after surgery, the day after surgery upon waking up, and one week after
surgery. Participation will not result in extra hospital visits.
Since the hypothesis is that the use of Arista* AH will result in less
postoperative complaints, there could be a benefit is terms of reduced
postoperative discomfort in the intervention group.