ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001266954p

Ethics application status

Submitted, not yet approved

Date submitted

5/10/2020

Date registered

25/11/2020

Date last updated

25/11/2020

Date data sharing statement initially provided

25/11/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

A synthetic haemostatic agent (PuraStat) for endonasal surgery

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1259-2254

Trial acronym

SHAPES

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nasal obstruction

Condition category

Condition code

Surgery

Surgical techniques

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Drug: Oxidised regenerated cellulose
Dose: 1x2 inch sheet
Duration: Single intra-operative dose
Mode: Topical

Control group

Active

Outcomes

Primary outcome [1]

Hospital recorded or participant-reported bleeding events in the first 24 hours post-operatively

Grading scale (significant bleeding if 2+)::
0: No bleeding or bleeding settling without intervention
1: Bleeding settling with digital pressure or topical decongestant sprays
2: Bleeding requiring bedside cautery or further topical haemostats
3. Bleeding requiring prolonged tamponade
4: Bleeding requiring return to theatre

Timepoint [1]

Up to 24 hours post-operatively (inpatient and outpatient)

Secondary outcome [1]

Patient-reported bleeding events from 24 hours post-operatively to 6 weeks post-operatively

Grading scale (significant bleeding if 2+)::
0: No bleeding or bleeding settling without intervention
1: Bleeding settling with digital pressure or topical decongestant sprays
2: Bleeding requiring bedside cautery or further topical haemostats
3. Bleeding requiring prolonged tamponade
4: Bleeding requiring return to theatre

Timepoint [1]

Standardised 6 week follow-up

Secondary outcome [2]

Severity of crusting by endoscopic evaluation

Grading scale:
0: Absent
1: Minimal
2: Moderate
3: Abundant

Timepoint [2]

Standardised 6 week follow-up

Secondary outcome [3]

Proportion of patients requiring antibiotics or with evidence of active local infection

Timepoint [3]

Standardised 6 week follow-up

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will be concealed using sealed, opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be performed using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Preliminary results from a sheep study using RADA16 show nil significant post-operative bleeding events and no adhesion formation in 30 sheep followed for an identical time period following endoscopic turbinate surgery. Similarly, results from a 2017 case series "A novel haemostatic agent based on self-assembling peptides in the setting of nasal endoscopic surgery, a case series" found a 0% incidence of post-operative bleeding events and adhesion formation in 60 patients undergoing endoscopic nasal surgery where RADA16 was applied.

No literature exists with documented expected rates of post-operative haemorrhage following endoscopic nasal surgery using either RADA16 or oxidised regenerated cellulose. As such, by professional opinion, a sample size of 200 patients will allow for a sufficiently powered study.

This project will be a one-tailed test for the hypothesis that RADA16 offers comparable rates of haemostasis as compared with oxidised regenerated cellulose and improved adhesion prevention. A Student's T-test will be used to determine if there is a statistical significance between the two arms.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2021

Actual

Date of last participant enrolment

Anticipated

1/06/2022

Actual

Date of last data collection

Anticipated

1/08/2022

Actual

Sample size

Target

209

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Macquarie University Hospital - Macquarie Park

Recruitment hospital [2]

Sydney Day Surgery - Darlinghurst

Recruitment hospital [3]

Campbelltown Private Hospital - Campbelltown

Recruitment postcode(s) [1]

2109 - Macquarie Park

Recruitment postcode(s) [2]

2010 - Darlinghurst

Recruitment postcode(s) [3]

2560 - Campbelltown

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

3-D Matrix Asia Pte. Ltd.

Address [1]

9 Raffles Place, Level 58 Republic Plaza, Singapore 048619\

Country [1]

Singapore

Primary sponsor type

Charities/Societies/Foundations

Name

RPA Institute of Academic Surgery

Address

145-147 Missenden Road Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Arjuna Ananda

Address [1]

Macarthur ENT
4 Hyde Parade, Campbelltown NSW 2560

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Rahuram Sivasubramaniam

Address [1]

Macarthur ENT
4 Hyde Parade, Campbelltown NSW 2560

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Yuresh Naidoo

Address [2]

Macarthur ENT
4 Hyde Parade, Campbelltown NSW 2560

Country [2]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

SLHD RPA Ethics Committee

Ethics committee address [1]

Sydney Local Health District
Level 11, KGV Building Missenden Road 
Camperdown NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/10/2020

Approval date [1]

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michael Lee

Address

RPA Institute of Academic Surgery
145-147 Missenden Road Camperdown NSW 2050

Country

Australia

Phone

+61404422321

Fax

94michaellee@gmail.com

Contact person for public queries

Name

Michael Lee

Address

RPA Institute of Academic Surgery
145-147 Missenden Road Camperdown NSW 2050

Country

Australia

Phone

+61404422321

Fax

94michaellee@gmail.com

Contact person for scientific queries

Name

Michael Lee

Address

RPA Institute of Academic Surgery
145-147 Missenden Road Camperdown NSW 2050

Country

Australia

Phone

+61404422321

Fax

94michaellee@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data underlying published results only, after de-identification

When will data be available (start and end dates)?

Data available after expected date of publication (01/07/2023) with no end date

Available to whom?

Researchers who provide a methodologically sound proposal

Available for what types of analyses?

For IPD/meta-analyses

How or where can data be obtained?

Access subject to approvals by co-ordinating investigator: email to 94michaellee@gmail.com

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9845	Study protocol			94michaellee@gmail.com	By correspondence with the co-ordinating investiga... [More Details]

Results publications and other study-related documents

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