Trial Outcomes & Findings for A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing (NCT NCT00707486)
NCT ID: NCT00707486
Last Updated: 2013-01-09
Results Overview
This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
72 participants
Primary outcome timeframe
Minutes After Application
Results posted on
2013-01-09
Participant Flow
Subjects were recruited as they presented at the site of the study for extraction. Subjects served as their own control as they had four extractions per procedure and two served as the experimental sites and two served as the control sites.
Participant milestones
| Measure |
Hemcon Dental Dressing With Pressure
Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
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|---|---|
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Overall Study
STARTED
|
72
|
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Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Hemcon Dental Dressing With Pressure
Subjects served as their own control. Subject had both the HemCon Dental Dressing and one of two controls: Gelfoam or Gauze with pressure. Subjects had paired extractions; each extraction site within the pair were randomized to the HemCon Dental Dressing or to a control.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
A Randomized, Self Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing
Baseline characteristics by cohort
| Measure |
Hemcon Dental Dressing and Gauze With Pressure
n=72 Participants
In the case of this study, participants served as their own control.
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|---|---|
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Age, Categorical
<=18 years
|
30 Participants
n=39 Participants
|
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Age, Categorical
Between 18 and 65 years
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42 Participants
n=39 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=39 Participants
|
|
Age Continuous
|
19.1 years
STANDARD_DEVIATION 3.95 • n=39 Participants
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Sex: Female, Male
Female
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34 Participants
n=39 Participants
|
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Sex: Female, Male
Male
|
38 Participants
n=39 Participants
|
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Region of Enrollment
United States
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72 participants
n=39 Participants
|
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Diastolic Blood Pressure
|
73.3 mmHg
STANDARD_DEVIATION 8.36 • n=39 Participants
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|
Systolic Blood Pressure
|
128.1 mmHg
STANDARD_DEVIATION 15.13 • n=39 Participants
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PRIMARY outcome
Timeframe: Minutes After ApplicationPopulation: Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.
This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.
Outcome measures
| Measure |
HemCon
n=140 Extraction Sites
Experimental
|
Control: Gauze
n=140 Extraction Sites
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Total
n=280 Extraction Sites
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|---|---|---|---|
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Time to Hemostasis
|
1.9 Minutes
Standard Error 1.36
|
9.8 Minutes
Standard Error 3.96
|
6.0 Minutes
Standard Error 5.09
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SECONDARY outcome
Timeframe: 1 week post surgeryOutcome measures
| Measure |
HemCon
n=34 Participants
Experimental
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Control: Gauze
n=18 Participants
|
Total
n=68 Participants
|
|---|---|---|---|
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Incidence of Post Surgical Sequelae
Pain Score: None
|
41.2 Percent of Participants
|
55.6 Percent of Participants
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41.2 Percent of Participants
|
|
Incidence of Post Surgical Sequelae
Pain Score: Mild
|
38.2 Percent of Participants
|
38.9 Percent of Participants
|
44.1 Percent of Participants
|
|
Incidence of Post Surgical Sequelae
Pain Score: Moderate
|
14.7 Percent of Participants
|
0 Percent of Participants
|
10.3 Percent of Participants
|
|
Incidence of Post Surgical Sequelae
Pain Score: Severe
|
2.9 Percent of Participants
|
0 Percent of Participants
|
1.5 Percent of Participants
|
|
Incidence of Post Surgical Sequelae
Healing Score: HemCon Better than Control
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0 Percent of Participants
|
0 Percent of Participants
|
14.7 Percent of Participants
|
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Incidence of Post Surgical Sequelae
Healing Score: HemCon Same as Control
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0 Percent of Participants
|
0 Percent of Participants
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29.4 Percent of Participants
|
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Incidence of Post Surgical Sequelae
Healing Score: HemCon Worse than Control
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0 Percent of Participants
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0 Percent of Participants
|
4.4 Percent of Participants
|
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Incidence of Post Surgical Sequelae
Gingival Inflammation: None
|
85.3 Percent of Participants
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77.8 Percent of Participants
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73.5 Percent of Participants
|
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Incidence of Post Surgical Sequelae
Gingival Inflammation: Mild
|
11.8 Percent of Participants
|
5.6 Percent of Participants
|
16.2 Percent of Participants
|
|
Incidence of Post Surgical Sequelae
Gingival Inflammation: Moderate
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0 Percent of Participants
|
11.1 Percent of Participants
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7.4 Percent of Participants
|
|
Incidence of Post Surgical Sequelae
Gingival Inflammation: Severe
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0 Percent of Participants
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0 Percent of Participants
|
0 Percent of Participants
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Adverse Events
Hemcon Dental Dressing and Gauze With Pressure
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hemcon Dental Dressing and Gauze With Pressure
n=71 participants at risk
In the case of this study, participants served as their own control.
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|---|---|
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General disorders
Dry Socket
|
26.8%
19/71 • Number of events 19 • Adverse events were assessed for over the time in which the patient was in the care of the oral surgeon or was enrolled in the study. In most cases, the time frame for the subject was seven days.
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General disorders
Packed Food
|
1.4%
1/71 • Number of events 1 • Adverse events were assessed for over the time in which the patient was in the care of the oral surgeon or was enrolled in the study. In most cases, the time frame for the subject was seven days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place