Real-world evaluation of a novel, adhesion device for the prevention of post-operative bleeding
| ISRCTN | ISRCTN54521345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54521345 |
| Secondary identifying numbers | Cura PMCF 1 |
- Submission date
- 20/06/2023
- Registration date
- 26/06/2023
- Last edited
- 23/06/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Haemostats are medical devices used by surgeons to stop bleeding during procedures and also to prevent bleeding restarting after the procedure has been completed. Not all haemostats stick to the bleeding site and so are less effective at preventing post-operative bleeding. Many of the haemostats that can adhere to the bleeding site use biological or chemical agents to achieve this. This study aims to evaluate a new haemostat (TenaTac) that avoids the use of biologic or chemical agents.
Who can participate?
Patients undergoing planned surgery at one of the participating hospitals if their surgeon is part of the evaluation group
What does the study involve?
During surgery, if the surgeon needs to use a haemostat and chooses to use TenaTac, then on completion of the surgery the surgeon will complete a structured questionnaire about how well the TenaTac performed.
What are the possible benefits and risks of participating?
The benefits are that the patient will avoid exposure to the biological or chemical agents used in alternative haemostats. The risks are that the TenaTac doesn't perform as well as another haemostat.
Where is the study run from?
St John's Innovation Centre, Cambridge, UK.
When is the study starting and how long is it expected to run for?
January 2020 to December 2025.
Who is funding the study?
The co-sponsors of the study are Selentus Science (UK) and CuraMedrix (Netherlands).
Who is the main contact?
Mr Paul Hayes MD FRCS, phayes@selentus.com
Contact information
Public
BioCity, 1 Thoresby Street
Nottingham
NG1 1GF
United Kingdom
 ORCID ID |
0000-0002-1968-5930 |
|---|---|
| Phone | +44 1159124210 |
| enquiry@selentus.com |
Scientific
Biocity, 1 Thoresby Street
Nottingham
NG1 1GF
United Kingdom
| Phone | +44 1159124210 |
|---|---|
| phayes@selentus.com |
Principal Investigator
BioCity, 1 Thoresby Street
Nottingham
NG1 1GF
United Kingdom
| Phone | +44 1159124210 |
|---|---|
| phayes@selentus.com |
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Real-world, post-market clinical study of the intra-procedural performance of a novel adhesive haemostat across six surgical specialities |
| Study objectives | A novel adherent haemostat using only a simple physical modification of its surface would adhere adequately to tissues, and effect haemostasis on a bleeding surgical site to the satisfaction of the operating surgeon. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study is a post-market clinical follow up of a CE-marked medial device being used within its Indication for Use. The choice of which haemostat to treat the patient with was at the discretion of the surgeon and no mandating of treatment occurred. No patient data was shared, only information relating to the general type of surgery and the performance of the device. |
| Health condition(s) or problem(s) studied | Treatment of haemorrhage in surgical patients |
| Intervention | A novel haemostat using only a physical modification of the device surface to affect adhesion was evaluated by multiple surgeons, across 6 surgical specialities. A structured questionnaire relating to the device performance was completed by the surgeon at the end of the procedure. The application of a haemostat to the bleeding site. No control agent is planned. The adherence of the haemostat to the tissue surface will be graded 1 to 5 by the surgeon, as will the efficacy of haemostasis obtained. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | TenaTac |
| Primary outcome measure | The effectiveness of haemostasis graded from 1 (unacceptable) to 5 (excellent) by the operating surgeon at the end of the procedure. |
| Secondary outcome measures | 1. The effectiveness of adhesion graded from 1 (unacceptable) to 5 (excellent) by the operating surgeon at the end of the procedure. 2. The ease of use of the haemostat graded from 1 (unacceptable) to 5 (excellent) by the operating surgeon at the end of the procedure. 3. Binary response to whether the surgeon would use the product again during surgery |
| Overall study start date | 01/10/2021 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Patient undergoing elective surgery 2. Patient greater than 16 years of age 3. Able to give informed consent 4. Willing to complete study procedures and attend for follow-up visit |
| Key exclusion criteria | 1. Presence of a documented disorder of coagulation 2. An INR >2.0 within 12h of surgery (if measured) 3. Allergy to porcine products 4. Use of dual anti-platelets within 3 days of surgery 5. Oral anti-coagulant use within 24h of surgery 6. Enrolment in another clinical study that might reasonably interfere with this study’s end-points 7. Member of a vulnerable group of adults or life expectancy less than one year. |
| Date of first enrolment | 14/01/2020 |
| Date of final enrolment | 01/11/2025 |
Locations
Countries of recruitment
- Belgium
- Croatia
- Denmark
- England
- France
- Germany
- Netherlands
- Serbia
- Sweden
- United Kingdom
Study participating centres
Ghent
9000
Belgium
Belgrade
11050
Serbia
Beeskow
15848
Germany
Antwerp
2650
Belgium
Cambridge
CB4 0WS
United Kingdom
University of Cologne
Cologne
50937
Germany
Sponsor information
Industry
Biocity, 1 Thoresby Street
Nottingham
NG1 1GF
England
United Kingdom
| Phone | +44 1159124210 |
|---|---|
| enquiry@selentus.com | |
| Website | https://www.selentus.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | As this is a novel device we plan to evaluate the data after 20%, 50% and 100% of the cohort has been recruited. The results will then be published in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to commercial sensitivity |
Editorial Notes
23/06/2023: Trial's existence confirmed by Isabelle Van Herzeele Dept of Thoracic and Vascular Surgery Ghent University Hospital
