A synthetic haemostatic agent (PuraStat) for endonasal surgery

A multi-centre prospective randomised controlled trial to evaluate the efficacy and safety of a synthetic haemostatic gel (PuraStat) for bleeding prevention post endoscopic nasal surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001266954

Acronym

SHAPES

Enrollment

209

Registered

2020-11-25

Start date

2021-01-01

Completion date

2022-06-01

Last updated

2020-11-30

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

Conditions

None listed

Brief summary

Bleeding is among the most common complications following endoscopic sinus and turbinate surgery and has historically been managed through the use of nasal packing. Haemostatic gels are seeing as use as an alternative method that is more comfortable for patients and reduces complications due to excessive tamponade by packs. This study evaluates the effect of RADA16, a nanopeptide based haemostatic hydrogel with a proposed role in reducing post-operative bleeding as well as reducing the incidence of other common complications including crusting/adhesion formation and chronic nasal infection, in the setting of endoscopic nasal surgery.

Interventions

Patients selected will have nasal obstruction and be planned for endoscopic nasal surgery with bilateral nasal turbinectomies/turbinate reductions Drug: RADA16 nanopeptide gel Dose: 5 mLs Duration: Single intra-operative dose Mode: Topical

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results