A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
|Tooth Extractions||Device: Hemcon Dental Dressing Device: Gauze with Pressure and/or Gelfoam||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing|
- Time to Hemostasis [ Time Frame: Minutes After Application ]This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.
- Incidence of Post Surgical Sequelae [ Time Frame: 1 week post surgery ]
|Study Start Date:||June 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Hemcon Dental Dressing
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
The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
Active Comparator: Gauze with pressure and/or Gelfoam
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707486
|United States, Oregon|
|Rodney Nichols, DMD|
|Milwaukie, Oregon, United States, 97222|
|Jay P. Malmquist, DMD|
|Portland, Oregon, United States, 97221|
|Principal Investigator:||Jay P Malmquist, DMD|