Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

Oral Hemorrhage Clinical Trial

Official title:

Observational, Multicenter, Prospective Clinical Study, Measuring the Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05171231
• Other study ID #: HEM 2021-07
• Secondary ID: 2021-A01764-37
• Status: Completed
• Start date: November 3, 2021
• Est. completion date: March 7, 2022

Study information

• Verified date: December 2022
• Source: Septodont
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 7, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Oral Hemorrhage

Intervention

Device:
• HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
HEMOCOLLAGENE® is an absorbable, sterile and hemostatic sponge, composed of type I undenatured, native and lyophilized bovine collagen (0.027 g per sponge). HEMOCOLLAGENE® will be inserted into oral sites (mainly the alveoli dental) after post-extraction or post-invasive dental surgical procedure, in case of bleeding not controled by usual hemostatic method. HEMOCOLLAGENE® will be let in place and will undergo a complete and natural absorption after several weeks.

Locations

Country	Name	City	State
Belgium	Cabinet Dento Médical, cabinet de Nivelles	Baulers
Belgium	Cabinet Dentaire	Bruxelles
France	Cabinet dentaire	Chassieu
France	Cabinet dentaire Grange-Blanche	Lyon
France	Cabinet Medical	Lyon
France	HCL-Hospices Civil de Lyon	Lyon
France	SCM Chirurgie Dentaire Opéra	Lyon
France	APHP- Hôpital de la Pitié Salpetrière	Paris
France	Cabinet dentaire	Roanne
France	Cabinet dentaire	Villefranche sur Saône

Sponsors (4)

Lead Sponsor	Collaborator
Septodont	EndoData, ReCOL, Symatese

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostatic Performance at 5 minutes	Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.	5 minutes after treatment onset
Secondary	Rate of overall adverse events	overall Safety assessment	From treatment onset to 30 days
Secondary	Rate of device related adverse events	Safety assessment relating to the medical device	From treatment onset to 30 days
Secondary	Wound Healing	Evaluation of the wound healing using the Landry Score (from "1 - Very Poor" to "5 - Excellent")	At 30 days
Secondary	Ease of the use of Hemocollagene by the Dentist	Satisfaction of the dentist on the use and the quality of HEMOCOLLAGENE® : Data relating to the hemostatic agent HEMOCOLLAGENE® (number, reference, quality before and during use).; The technique for using HEMOCOLLAGENE® (cutting before or after application, removal or not for hemostasis, fixing).; The intraoperative satisfaction of the practitioner.	At day 0, after using the treatment
Secondary	Rate of hemostatic time at 10 minutes in case persistant bleeding	Percentage of patients with a bleeding stopped 10 minutes after treatment onset in case of persistant bleeding	10 minutes after treatment onset
Secondary	Rate of persistant bleeding	Percentage of patients with a bleeding not stopped 5 minutes after treatment onset	5 minutes after treatment onset