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

Tooth Extractions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707486
• Other study ID #: 2007-I-D-1
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2008
• Last updated: December 6, 2012
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2012
• Source: HemCon Medical Technologies, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

The HemCon® Bandage has been successfully used to achieve hemostasis in patients with high systolic pressure, high blood volume wounds, and to promote hemostasis on a massive scale compared to the hemostasis requirements of oral surgery wounds. Therefore, a human clinical trial has recently been completed evaluating the efficacy of using the HemCon® Bandage in a smaller finished size for dental extraction and other oral surgery sites. The HemCon® Bandage was proven to be significantly better at promoting hemostasis of oral surgery wounds than the control (cotton gauze or Gelfoam) in all subjects tested. All HemCon® Bandage sites achieved hemostasis faster than the control sites. Based on this data, a 510(k) was submitted and has received FDA clearance for the HemCon® Dental Dressing to be used as an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

This study evaluates the FDA cleared HemCon® Dental Dressing for use in hemostasis of soft oral tissue subsequent to dental surgical procedures such as tooth extractions excluding procedures involving primary closure of the HemCon® Dental Dressing within the oral wound.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Extractions

Intervention

Device:
• Hemcon Dental Dressing
The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
• Gauze with Pressure and/or Gelfoam
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.

Locations

Country	Name	City	State
United States	Rodney Nichols, DMD	Milwaukie	Oregon
United States	Jay P. Malmquist, DMD	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
HemCon Medical Technologies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of Post Surgical Sequelae		1 week post surgery	Yes