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

Completed

• Conditions: Oral Hemorrhage

• Registration Number: NCT05171231
• Lead Sponsor: Septodont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-03
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-28
• Primary Completion: 2022-03-07
• Study Completion: 2022-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemostatic Performance at 5 minutes	5 minutes after treatment onset	Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.

Secondary Outcome Measures

Name	Time	Method
Wound Healing	At 30 days	Evaluation of the wound healing using the Landry Score (from "1 - Very Poor" to "5 - Excellent")
Rate of persistant bleeding	5 minutes after treatment onset	Percentage of patients with a bleeding not stopped 5 minutes after treatment onset
Ease of the use of Hemocollagene by the Dentist	At day 0, after using the treatment	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.
Rate of device related adverse events	From treatment onset to 30 days	Safety assessment relating to the medical device
Rate of overall adverse events	From treatment onset to 30 days	overall Safety assessment
Rate of hemostatic time at 10 minutes in case persistant bleeding	10 minutes after treatment onset	Percentage of patients with a bleeding stopped 10 minutes after treatment onset in case of persistant bleeding

Trial Locations

Locations (8)

APHP- Hôpital de la Pitié Salpetrière; 🇫🇷 Paris, France

Cabinet Dento Médical, cabinet de Nivelles; 🇧🇪 Baulers, Belgium

Cabinet dentaire Grange-Blanche; 🇫🇷 Lyon, France

SCM Chirurgie Dentaire Opéra; 🇫🇷 Lyon, France

Cabinet Dentaire; 🇧🇪 Bruxelles, Belgium

Cabinet Medical; 🇫🇷 Lyon, France

Cabinet dentaire; 🇫🇷 Villefranche sur Saône, France

HCL-Hospices Civil de Lyon; 🇫🇷 Lyon, France