Otorhinolaryngologic DiseasesPRHEPOCENCT03243344
Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery
A study testing Surgiflo, Floseal and Algosteril in people with Otorhinolaryngologic Diseases, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otorhinolaryngologic Diseases
- What is being tested?
- Surgiflo, Floseal and Algosteril
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- endonasal surgery schedule
- Surgical indications:
- hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,
Who cannot join
- Pregnant Woman
- Disorder of the haemostasis known or disrupted preoperative biological balance assessment
- Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
- Unchecked HTA by the treatment and/or preoperative > mmHg 160/90
- Surgical Act including a septoplasty
- malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system
- Dacryocystorhinostomy
About this study
Official title: Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery
This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .
Read the detailed description
Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery.
Floseal® is a haemostatic frost(gel) containing of the thrombin.
Algosteril® is a lint tent of arginate of calcium.
- Conditions
- Otorhinolaryngologic Diseases
- Being tested
- Surgiflo, Floseal, Algosteril
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgifloDevice
using device during the endonasal surgery.
FlosealDevice
using device during the endonasal surgery.
AlgosterilDevice
using device during the endonasal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgiflo | Experimental | Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery. Receives: Device: Surgiflo |
| Floseal | Experimental | Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery Receives: Device: Floseal |
| Algosteril | Experimental | Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery Receives: Device: Algosteril |
| Abstention | No intervention | Not using device for the post-operative haemostasis in endonasal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-operative hemostasis
Time needs to observe hemostasis after the device set up
Measured: Hours 0
Hemostasis in the 6 first hours
Number of compresses used from Hours 0 to Hours 6.
Measured: Hours 6
Hemostasis at the 24th hour
- Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type)
- Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.
Measured: Hours 24
Spontaneous hemorrhagic events
number of spontaneous hemorrhagic events.
Measured: from Hours 0 to Day 45
Secondary outcomes (4)
Preoperative assessment
Preoperative scanner assessment with Lund ans Mackay score
Measured: Before the endonasal surgery
Preoperative assessment
Laboratory tests of hemostasis (platelets, fibrinogen...)
Measured: Hours 0
Device evaluation by the surgeon
time needs to set up the device
Measured: Hours 0
Device evaluation by the surgeon
subjective assessment of the implementation ease
Measured: Hours 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startMar 2010
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent TAVERNIER, PH, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243344
- Sponsor's protocol ID
- SHC/2009/001/P
- Acronym
- PRHEPOCE
- Status last verified
- Mar 2010
- First submitted
- 2 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery
- ClinicalTrials.gov ID
- NCT03243344
- Acronym / sponsor ID
- PRHEPOCE / SHC/2009/001/P
- Conditions
- Otorhinolaryngologic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .
Detailed description
Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery.
Floseal® is a haemostatic frost(gel) containing of the thrombin.
Algosteril® is a lint tent of arginate of calcium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgiflo | Experimental | Device: SurgifloUsing Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery. |
| Floseal | Experimental | Device: FlosealUsing Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery |
| Algosteril | Experimental | Device: AlgosterilUsing Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery |
| Abstention | No intervention | –Not using device for the post-operative haemostasis in endonasal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- endonasal surgery schedule
- Surgical indications:
- hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,
Key exclusion criteria (7 listed)
- Pregnant Woman
- Disorder of the haemostasis known or disrupted preoperative biological balance assessment
- Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
- Unchecked HTA by the treatment and/or preoperative > mmHg 160/90
- Surgical Act including a septoplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgiflousing device during the endonasal surgery. | Device | Surgiflo |
| Flosealusing device during the endonasal surgery. | Device | Floseal |
| Algosterilusing device during the endonasal surgery. | Device | Algosteril |
Primary outcome
Per-operative hemostasis
Time frame: Hours 0
Time needs to observe hemostasis after the device set up
Hemostasis in the 6 first hours
Time frame: Hours 6
Number of compresses used from Hours 0 to Hours 6.
Hemostasis at the 24th hour
Time frame: Hours 24
* Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type) * Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.
Spontaneous hemorrhagic events
Time frame: from Hours 0 to Day 45
number of spontaneous hemorrhagic events.
4 secondary outcomes
Preoperative assessment
Time frame: Before the endonasal surgery
Preoperative assessment
Time frame: Hours 0
Device evaluation by the surgeon
Time frame: Hours 0
Device evaluation by the surgeon
Time frame: Hours 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent TAVERNIER, PH principal investigator
CHU Besançon
Questions about this trial
What is this clinical trial studying?
A study testing Surgiflo, Floseal and Algosteril in people with Otorhinolaryngologic Diseases, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-operative hemostasis (time frame: Hours 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.