Trial Outcomes & Findings for Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures (NCT NCT00635479)

Last Updated: 2017-12-11

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

Until wound healed, up to 1 year

Results posted on

2017-12-11

Participant milestones
Measure	VAC Device Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision	Gauze Dressing Gauze Dressing Gauze dressing: Gauze dressing for surgical incision
Overall Study STARTED	55	60
Overall Study COMPLETED	49	42
Overall Study NOT COMPLETED	6	18

Withdrawal data not reported

Role of Vacuum Assisted Closure (VAC) Device in Postoperative Management of Pelvic and Acetabular Fractures

Baseline characteristics by cohort
Measure	VAC Device n=55 Participants Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision	Gauze Dressing n=60 Participants Gauze Dressing Gauze dressing: Gauze dressing for surgical incision	Total n=115 Participants Total of all reporting groups
Age, Continuous	47.2 years STANDARD_DEVIATION 19.6 • n=93 Participants	48.3 years STANDARD_DEVIATION 20.1 • n=4 Participants	47.6 years STANDARD_DEVIATION 19.9 • n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	19 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	43 Participants n=93 Participants	41 Participants n=4 Participants	84 Participants n=27 Participants
Region of Enrollment United States	55 participants n=93 Participants	60 participants n=4 Participants	115 participants n=27 Participants

Timeframe: Until wound healed, up to 1 year

Outcome measures
Measure	VAC Device n=49 Participants Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision	Gauze Dressing n=42 Participants Gauze Dressing Gauze dressing: Gauze dressing for surgical incision
Number of Participants With Wound Infections	5 participants	2 participants

Serious events: 15 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 9 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	VAC Device n=49 participants at risk Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision	Gauze Dressing n=42 participants at risk Gauze Dressing Gauze dressing: Gauze dressing for surgical incision
Infections and infestations infection	20.4% 10/49	9.5% 4/42
Gastrointestinal disorders Perforated colon	2.0% 1/49	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Pneumonia	2.0% 1/49	2.4% 1/42
Vascular disorders CVA	0.00% 0/49	2.4% 1/42
Surgical and medical procedures implant failure	4.1% 2/49	2.4% 1/42
General disorders prescription overdose	2.0% 1/49	0.00% 0/42
Vascular disorders DVT	0.00% 0/49	2.4% 1/42
Vascular disorders PE	0.00% 0/49	2.4% 1/42

Other adverse events
Measure	VAC Device n=49 participants at risk Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision	Gauze Dressing n=42 participants at risk Gauze Dressing Gauze dressing: Gauze dressing for surgical incision
Renal and urinary disorders urinary tract infection	0.00% 0/49	4.8% 2/42
Gastrointestinal disorders ileus	2.0% 1/49	0.00% 0/42
Nervous system disorders Regional Pain Syndrome	0.00% 0/49	2.4% 1/42
Respiratory, thoracic and mediastinal disorders pneumomediastinum	2.0% 1/49	0.00% 0/42
Vascular disorders hematoma	2.0% 1/49	0.00% 0/42
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignancy, unrelated	0.00% 0/49	2.4% 1/42
General disorders fall, no injury	0.00% 0/49	2.4% 1/42

University of Missouri, Department of Orthopaedics

Phone: 573-882-6562