Trial Outcomes & Findings for Vacuum Assisted Closure as a Treatment for Open Fractures (NCT NCT00582361)
NCT ID: NCT00582361
Last Updated: 2013-08-14
Results Overview
Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
from surgery to wound closure
Results posted on
2013-08-14
Participant Flow
Patients admitted through the emergency department that met the criteria for the study were approached.
Participant milestones
| Measure |
Standard Dressing Group (1, A)
Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
|
Vacuum Assisted Closure Group (2, B)
Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
38
|
|
Overall Study
COMPLETED
|
25
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vacuum Assisted Closure as a Treatment for Open Fractures
Baseline characteristics by cohort
| Measure |
Standard Dressing Group (1, A)
n=25 Participants
Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
|
Vacuum Assisted Closure Group (2, B)
n=38 Participants
Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 16 • n=5 Participants
|
38 years
STANDARD_DEVIATION 15 • n=7 Participants
|
41 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
38 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from surgery to wound closureHealing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
Outcome measures
| Measure |
Standard Dressing Group (1, A)
n=23 Participants
Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
|
Vacuum Assisted Closure Group (2, B)
n=35 Participants
Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
|
|---|---|---|
|
Healing of Orthopaedic Trauma Open Fractures
|
3.2 use days
Interval 2.0 to 9.0
|
4.0 use days
Interval 2.0 to 11.0
|
PRIMARY outcome
Timeframe: Up to 12 monthsNumber of acute, delayed and deep wound infections.
Outcome measures
| Measure |
Standard Dressing Group (1, A)
n=25 Participants
Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
|
Vacuum Assisted Closure Group (2, B)
n=37 Participants
Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
|
|---|---|---|
|
Infections
|
7 Number of infections
|
2 Number of infections
|
Adverse Events
Standard Dressing Group (1, A)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Vacuum Assisted Closure Group (2, B)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Dressing Group (1, A)
n=25 participants at risk
Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
|
Vacuum Assisted Closure Group (2, B)
n=38 participants at risk
Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Nonunion
|
0.00%
0/25 • Through 12 months (date of surgery through 12 months)
|
2.6%
1/38 • Number of events 1 • Through 12 months (date of surgery through 12 months)
|
|
Skin and subcutaneous tissue disorders
Required Flap Coverage
|
0.00%
0/25 • Through 12 months (date of surgery through 12 months)
|
2.6%
1/38 • Number of events 1 • Through 12 months (date of surgery through 12 months)
|
|
Musculoskeletal and connective tissue disorders
Infection
|
4.0%
1/25 • Number of events 1 • Through 12 months (date of surgery through 12 months)
|
0.00%
0/38 • Through 12 months (date of surgery through 12 months)
|
|
Musculoskeletal and connective tissue disorders
Amputation
|
0.00%
0/25 • Through 12 months (date of surgery through 12 months)
|
2.6%
1/38 • Number of events 1 • Through 12 months (date of surgery through 12 months)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place