Clinical trial NCT05171231: Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
Official title: Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Hemorrhage
Keywords: Surgical Hemostatic
Oral Surgery
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: Symatese
name: Recherche Clinique en Odontologie (ReCOL)
name: EndoData
First posted: 2021-12-28
Enrollment: 125
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is made with the recruitment of participating centers which included at least one patient.

The analysis will be carried out on the patients included with evaluable observation sheets . The evaluability of a form will be defined during the development of the analysis plan according to the number of missing data and the nature of missing data.

The analysis sets are defined below:

* Intented-to-treat (ITT) population: The ITT population consists of all subjects not opposed to the use of their clinical data and implanted by the HEMOCOLLAGENE® medical device. This population will be the primary population analysis for safety and efficacy.
* Per Protocol (PP): The PP population includes all the patients implanted by the medical device HEMOCOLLAGENE® without any major deviation from the protocol. Protocol violations will be graded (major / minor) when reviewing data before database lock. This population will be the secondary population analysis.

Brief summary: The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental surgery.

Patients will The data collected from the Post-Market Clinical Follow-up study will be used to support the regulatory requirements of post-market monitoring (risk management, residual risks, instructions for use...) and to increase the manufacturer's clinical data. Patients will be followed for 1 month.

Adverse events (safety) and device performance will be collected by the dentist during the routine follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Patient requiring oral surgery
* Patient with a bleeding requiring the use of an adjuvant hemostatic
* Patient implanted with HEMOCOLLAGENE® in dental surgery.
* Patient who signed his informed consent form

Exclusion Criteria:

* Inform Consent not signed
* Patients with acute oral infection.
* Patients with an unstable hemodynamic state (acute and/or chronic cardiovascular pathology, low arterial pressure, cardiac rhythm problem)
* Pregnant and / or breastfeeding patients.
* Patient with hypersensitivity or allergy to bovine collagen

Primary outcomes:
measure: Hemostatic Performance at 5 minutes
timeFrame: 5 minutes after treatment onset
Secondary outcomes:
measure: Rate of overall adverse events
timeFrame: From treatment onset to 30 days
measure: Rate of device related adverse events
timeFrame: From treatment onset to 30 days
measure: Wound Healing
timeFrame: At 30 days
measure: Ease of the use of Hemocollagene by the Dentist
timeFrame: At day 0, after using the treatment
measure: Rate of hemostatic time at 10 minutes in case persistant bleeding
timeFrame: 10 minutes after treatment onset
measure: Rate of persistant bleeding
timeFrame: 5 minutes after treatment onset
Other outcomes:
Locations:
city: Baulers
country: Belgium
facility: Cabinet Dento Médical, cabinet de Nivelles
city: Bruxelles
country: Belgium
facility: Cabinet Dentaire
city: Chassieu
country: France
facility: Cabinet dentaire
city: Lyon
country: France
facility: SCM Chirurgie Dentaire Opéra
city: Lyon
country: France
facility: Cabinet Medical
city: Lyon
country: France
facility: HCL-Hospices Civil de Lyon
city: Lyon
country: France
facility: Cabinet dentaire Grange-Blanche
city: Paris
country: France
facility: APHP- Hôpital de la Pitié Salpetrière
city: Roanne
country: France
facility: Cabinet dentaire
city: Villefranche sur Saône
country: France
facility: Cabinet dentaire
Study officials:
affiliation: CHU de Lyon, France
name: Brigitte Grosgogeat, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Guillet, Marie, et al. "Adjuvant Hemostasis in Dental Surgery: Real-Life Practice Data in The Observational, Multi-Center, Prospective, Hemocollagene Clinical Trial." International Journal of Health & Medical Research 3.12 (2024).