Trial Review

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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] 302472 0
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 319303 0
Condition category
Condition code
Surgery 317275 317275 0 0
Surgical techniques
Respiratory 317664 317664 0 0
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] 318766 0
Treatment: Surgery
Intervention code [2] 318767 0
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] 325330 0
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] 325330 0
Up to 24 hours post-operatively (inpatient and outpatient)
Secondary outcome [1] 387550 0
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] 387550 0
Standardised 6 week follow-up
Secondary outcome [2] 388881 0
Severity of crusting by endoscopic evaluation

Grading scale:
0: Absent
1: Minimal
2: Moderate
3: Abundant
Timepoint [2] 388881 0
Standardised 6 week follow-up
Secondary outcome [3] 388882 0
Proportion of patients requiring antibiotics or with evidence of active local infection
Timepoint [3] 388882 0
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?
No
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] 17742 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 17743 0
Sydney Day Surgery - Darlinghurst
Recruitment hospital [3] 17744 0
Campbelltown Private Hospital - Campbelltown
Recruitment postcode(s) [1] 31598 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 31599 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 31600 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 306832 0
Commercial sector/Industry
Name [1] 306832 0
3-D Matrix Asia Pte. Ltd.
Country [1] 306832 0
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] 307457 0
Individual
Name [1] 307457 0
Arjuna Ananda
Address [1] 307457 0
Macarthur ENT
4 Hyde Parade, Campbelltown NSW 2560
Country [1] 307457 0
Australia
Other collaborator category [1] 281501 0
Individual
Name [1] 281501 0
Rahuram Sivasubramaniam
Address [1] 281501 0
Macarthur ENT
4 Hyde Parade, Campbelltown NSW 2560
Country [1] 281501 0
Australia
Other collaborator category [2] 281502 0
Individual
Name [2] 281502 0
Yuresh Naidoo
Address [2] 281502 0
Macarthur ENT
4 Hyde Parade, Campbelltown NSW 2560
Country [2] 281502 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306995 0
SLHD RPA Ethics Committee
Ethics committee address [1] 306995 0
Sydney Local Health District
Level 11, KGV Building Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 306995 0
Australia
Date submitted for ethics approval [1] 306995 0
19/10/2020
Approval date [1] 306995 0
Ethics approval number [1] 306995 0

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 105682 0
Dr Michael Lee
Address 105682 0
RPA Institute of Academic Surgery
145-147 Missenden Road Camperdown NSW 2050
Country 105682 0
Australia
Phone 105682 0
+61404422321
Fax 105682 0
Email 105682 0
[email protected]
Contact person for public queries
Name 105683 0
Dr Michael Lee
Address 105683 0
RPA Institute of Academic Surgery
145-147 Missenden Road Camperdown NSW 2050
Country 105683 0
Australia
Phone 105683 0
+61404422321
Fax 105683 0
Email 105683 0
[email protected]
Contact person for scientific queries
Name 105684 0
Dr Michael Lee
Address 105684 0
RPA Institute of Academic Surgery
145-147 Missenden Road Camperdown NSW 2050
Country 105684 0
Australia
Phone 105684 0
+61404422321
Fax 105684 0
Email 105684 0
[email protected]

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 [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9845Study protocol  [email protected] By correspondence with the co-ordinating investiga... [More Details]



Results publications and other study-related documents

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