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

Septodont

Status: Completed

Conditions: Oral Hemorrhage

Treatments: Device: HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD

Study type: Observational

Funder types: NETWORK; Industry; Other

Identifiers

NCT05171231

HEM 2021-07

2021-A01764-37 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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