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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00635479
Enrollment
115
Registered
2008-03-13
Start date
2008-03-31
Completion date
2013-12-31
Last updated
2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Fractures, Acetabular Fractures, Hip Fractures

Keywords

Fractures, Pelvic bones, Acetabulum, Hip bones

Brief summary

The purpose of this research is to study the efficacy and cost effectiveness of the VAC device in comparison to traditional gauze wound dressing in pelvic, acetabular and hip fractures, specifically to see if there is a reduction in the incidence of post operative surgical wound drainage, infections, and hospital stay.

Detailed description

Soft tissue injuries are commonly associated with pelvic and acetabular injuries and additional tissue injury occurs during surgery. Post operative wound drainage, infections and prolonged hospital stay are a common problem during postoperative care. Traditional treatment is dressing of the surgical wound with different conventional dressings. Use of negative pressure wound therapy has been shown to be beneficial in significantly decreasing wound drainage. Stannard et al. reported the results of randomizing 44 patients with lower extremity fractures (including 4 pilon fractures) into either receiving standard post operative dressing versus NPWT (negative pressure wound therapy). His results showed no difference in infection rate or wound breakdown, but did show a significant difference in the drainage time. The NPWT group stopped draining 3 days earlier than the standard dressing group. The use of NPWT has greatly increased over the years and has been an important adjunct to wound management. These results and anecdotal clinical experience with the use of NPWT (wound VAC) has led us to develop our research question; Does the use of incisional VAC following pelvic &/or acetabular surgery decrease wound complications. The VAC (KCI USA) device is relatively new device that utilizes negative pressure as a treatment modality for soft tissue injuries following high velocity injuries. VAC device exerts intermittent or constant negative pressure and removes excess fluid from the interstitial space and increases perfusion through vessels. Previous VAC studies showed decreased bacterial load after applying VAC device to the infected wounds. There have been no randomized studies to prove the cost effectiveness and efficacy of VAC device in reducing wound drainage, infections, and prolonged hospital stays in comparison to traditional gauze dressing wound management during post operative management of pelvic and acetabular fractures. In examining the incidence of wound complications/infections, we can determine if the incisional VAC decreases the need for additional intervention and if there are any patient related factors (i.e. obesity) related to increased risk of wound complications.

Interventions

DEVICEVAC device

Vacuum Assisted Closure (VAC) device for surgical incision

Gauze dressing for surgical incision

Sponsors

University of California, Davis
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER
Medical College of Wisconsin
CollaboratorOTHER
University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * Scheduled for surgical repair of pelvic and/or acetabular fracture * Subject/guardian able to provide informed consent

Exclusion criteria

* Less than 18 years of age * Subject/guardian unable to provide informed consent

Design outcomes

Primary

MeasureTime frame
Number of Participants With Wound InfectionsUntil wound healed, up to 1 year

Countries

United States

Participant flow

Participants by arm

ArmCount
VAC Device
Vacuum Assisted Closure (VAC) device Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision
55
Gauze Dressing
Gauze Dressing Gauze dressing: Gauze dressing for surgical incision
60
Total115

Baseline characteristics

CharacteristicVAC DeviceGauze DressingTotal
Age, Continuous47.2 years
STANDARD_DEVIATION 19.6
48.3 years
STANDARD_DEVIATION 20.1
47.6 years
STANDARD_DEVIATION 19.9
Region of Enrollment
United States
55 participants60 participants115 participants
Sex: Female, Male
Female
12 Participants19 Participants31 Participants
Sex: Female, Male
Male
43 Participants41 Participants84 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 495 / 42
serious
Total, serious adverse events
15 / 499 / 42

Outcome results

Primary

Number of Participants With Wound Infections

Time frame: Until wound healed, up to 1 year

ArmMeasureValue (NUMBER)
VAC DeviceNumber of Participants With Wound Infections5 participants
Gauze DressingNumber of Participants With Wound Infections2 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026