A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing

NCT00707486 | Completed Phase 3 Results

• 1 other identifier: 2007-I-D-1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries.

Conditions

Tooth Extractions

Keywords

Hemostasis, tooth extractions, third molar

Outcome Measures

Primary Outcomes (1)

• Time to Hemostasis

  This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.

  Minutes After Application

Secondary Outcomes (1)

• Incidence of Post Surgical Sequelae

  1 week post surgery

Study Arms (2)

Hemcon Dental Dressing

EXPERIMENTAL

The HemCon® Bandage is an FDA-cleared chitosan-based flat bandage that controls severe arterial bleeding from traumatic injuries. In comparison to traditional bandages, the HemCon® Bandage provides superior control of bleeding, wound site adhesiveness, multiple injury site usage, biocompatibility and provides a barrier to infective agents.

Device: Hemcon Dental Dressing

Gauze with pressure and/or Gelfoam

ACTIVE COMPARATOR

Post operative care for oral surgery subjects consists of the subject biting on sterile cotton gauze to provide pressure to the extraction site. A common alternative practice involves the placement of Gelfoam (with or without antibiotic/steroid medication) into the extraction socket prior to application of the sterile gauze pressure dressing. This treatment was chosen as the study control to compare the HemCon Dental Dressing to the standard of care for oral surgery subjects, including the use of cotton gauze and/or Gelfoam to control post operative bleeding.

Device: Gauze with Pressure and/or Gelfoam

Interventions

Hemcon Dental Dressing DEVICE

The Hemcon Dental Dressing is an oral wound dressing made of chitosan.

Hemcon Dental Dressing

Gauze with Pressure and/or Gelfoam DEVICE

Common practice for oral surgery patients involves the use of sterile dressing over the extraction site. The subject will provide the pressure by biting down on the sterile gauze. As previously discussed, other practices involve the use of Gelfoam prior to application of sterile gauze.

Gauze with pressure and/or Gelfoam

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring 2 or 4 3rd molar tooth extraction procedures.
• Index pairing must reflect anatomically similar extraction locations, i.e., for 2 extractions both must be upper or both must be lower extractions.
• Patients must be 14 years of age or older
• Patients must be available for a minimum of one post operative evaluation to be scheduled at the time of the procedure approximately 7 days post surgery. Additional follow-up visits may be scheduled at the discretion of the surgeon based on the severity of particular patient cases or the patient's need for earlier follow-up.
• Extraction sites do not require primary closure or suturing
• Willingness and ability to provide informed consent/ assent for participation
• Patients with seafood allergies
• Patients who have discontinued the use of anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) for a minimum of 3 days prior to their planned surgical visit.

You may not qualify if:

• Scheduled to undergo a surgical procedure other than 3rd molar tooth extractions
• Scheduled to undergo 2 extractions whereby one is an upper 3rd molar and the other is a lower 3rd molar. These will not reflect a proper index pairing for statistical calculations and data analysis based on anatomical similarities.
• Extraction procedures are expected to require primary closure or suturing of the HemCon® Dental Dressing within the oral wound.
• Unable or unwilling to provide informed consent/ assent for participation as a subject
• Patients who are currently taking anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) or have discontinued their anticoagulant medications less than 3 days prior to their surgical visit.
• Patients who are undergoing bisphosphonate therapy.

Sponsors & Collaborators

• HemCon Medical Technologies, Inc: lead

Study Sites (2)

Rodney Nichols, DMD

Milwaukie, Oregon, 97222, United States

Location

Jay P. Malmquist, DMD

Portland, Oregon, 97221, United States

Location

Results Point of Contact

• Title: Staci McAdams
• Organization: HemCon Medical Technologies

staci@hemcon.com

(503)245-0459

Study Officials

• Jay P Malmquist, DMD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 9, 2013
• Results First Posted: January 9, 2013

Record last verified: 2012-12

Locations

US (2)