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

NCT05171231 | Completed

• 2 other identifiers: HEM 2021-072021-A01764-37
• Study Type: observational
• Target: 125
• Locations: 2 countries
• Sites: 10

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.

Conditions

Oral Hemorrhage

Keywords

Surgical Hemostatic; Oral Surgery

Outcome Measures

Primary Outcomes (1)

• Hemostatic Performance at 5 minutes

  Evaluation of the stop of the bleeding 5 minutes after using HEMOCOLLAGENE®.

  5 minutes after treatment onset

Secondary Outcomes (6)

• Rate of overall adverse events

  From treatment onset to 30 days

• Rate of device related adverse events

  From treatment onset to 30 days

• Wound Healing

  At 30 days

• Ease of the use of Hemocollagene by the Dentist

  At day 0, after using the treatment

• Rate of hemostatic time at 10 minutes in case persistant bleeding

  10 minutes after treatment onset

Interventions

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

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.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Septodont: lead
• Symatese: collaborator
• Recherche Clinique en Odontologie (ReCOL): collaborator
• EndoData: collaborator

Study Sites (10)

Cabinet Dento Médical, cabinet de Nivelles

Baulers, 4 B-1401, Belgium

Location

Cabinet Dentaire

Brussels, 1180, Belgium

Location

Cabinet dentaire

Chassieu, 69680, France

Location

SCM Chirurgie Dentaire Opéra

Lyon, 69001, France

Location

Cabinet Medical

Lyon, 69003, France

Location

HCL-Hospices Civil de Lyon

Lyon, 69007, France

Location

Cabinet dentaire Grange-Blanche

Lyon, 69008, France

Location

APHP- Hôpital de la Pitié Salpetrière

Paris, 75004, France

Location

Cabinet dentaire

Roanne, 42300, France

Location

Cabinet dentaire

Villefranche-sur-Saône, 69400, France

Location

Related Publications (1)

• 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).

  RESULT

MeSH Terms

Conditions

Oral Hemorrhage

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Oral Manifestations; Signs and Symptoms

Study Officials

• Brigitte Grosgogeat, MD, PhD

  CHU de Lyon, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 28, 2021
• Study Start: November 3, 2021
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); FR (8)