Trial Outcomes & Findings for Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries (NCT NCT00582998)
NCT ID: NCT00582998
Last Updated: 2019-07-25
Results Overview
Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
249 participants
Primary outcome timeframe
The time from injury from surgical stabilization (14 days)
Results posted on
2019-07-25
Participant Flow
Some of the participants had multiple fractures (there were a total of 263 fractures and 249 participants). The numbers reflected in the Participant Flow, Baseline Characteristics, and Adverse Events sections reflect participants and not fractures.
Unit of analysis: Fractures
Participant milestones
| Measure |
Standard Wound Dressing
Standard post-operative wound dressing
Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
|
Vacuum Assisted Closure Device
Vacuum Assisted Closure (VAC) device
VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
|
|---|---|---|
|
Overall Study
STARTED
|
119 122
|
130 141
|
|
Overall Study
COMPLETED
|
119 122
|
130 141
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
Baseline characteristics by cohort
| Measure |
Standard Wound Dressing
n=119 Participants
Standard post-operative wound dressing
Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
|
Vacuum Assisted Closure Device
n=130 Participants
Vacuum Assisted Closure (VAC) device
VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
|
Total
n=249 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
|
107 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
130 participants
n=7 Participants
|
249 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The time from injury from surgical stabilization (14 days)Population: The numbers reflected in the Participant Flow, Baseline Characteristics, and Adverse Events sections reflect participants and not fractures.
Healing of Orthopaedic Trauma Extremity Wounds: Calcaneus, Pilon and Tibial Plateau Fractures with standard dressing versus negative pressure wound therapy
Outcome measures
| Measure |
Standard Wound Dressing
n=122 Fractures
Standard post-operative wound dressing
Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
|
Vacuum Assisted Closure Device
n=141 Fractures
Vacuum Assisted Closure (VAC) device
VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
|
|---|---|---|
|
Healing of Orthopaedic Trauma Extremity Wound Fractures (Calcaneus, Pilon and Tibial Plateau)
|
99 Fractures
|
127 Fractures
|
Adverse Events
Standard Wound Dressing
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Vacuum Assisted Closure Device
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Wound Dressing
n=119 participants at risk
Standard post-operative wound dressing
Standard Wound Dressing: Following repair of fracture of calcaneus, pilon or tibial plateau, a standard wound dressing is applied in the OR. Dressing is taken down post-op day 1 to evaluate draining, and if necessary, replaced. Dressing will be monitored for drainage every 48 hours until wound is clean, dry and intact.
|
Vacuum Assisted Closure Device
n=130 participants at risk
Vacuum Assisted Closure (VAC) device
VAC: Following repair of fracture of calcaneus, pilon or tibial plateau, a Vacuum Assisted Closure (VAC) device is applied in the OR. VAC cannister is evaluated for drainage, and if necessary, replaced. VAC sponge will be monitored for drainage every 48 hours, replaced if needed, until wound is clean, dry and intact.
|
|---|---|---|
|
Infections and infestations
Adverse Event
|
19.3%
23/119 • Number of events 23 • 12 months
|
10.8%
14/130 • Number of events 14 • 12 months
|
|
Surgical and medical procedures
Wound Dehiscence
|
16.8%
20/119 • Number of events 20 • 12 months
|
9.2%
12/130 • Number of events 12 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place