NCT00707486

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: HemCon Medical Technologies, Inc · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tooth Extractions

Interventions

Type	Name	Description
DEVICE	Hemcon Dental Dressing	The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
DEVICE	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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-01-01
• Completion: 2009-07-01
• First posted: 2008-07-01
• Last updated: 2013-01-09
• Results posted: 2013-01-09

Locations

2 sites across 1 country: United States