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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

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

• NCT number: NCT00707486
• Study type: Interventional
• Source: HemCon Medical Technologies, Inc
• Status: Completed
• Phase: Phase 3
• Start date: June 2008
• Completion date: July 2009