## Protocol Section
### Identification Module
**NCT ID:** NCT00635479

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

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

#### Organization Study ID Info
**ID:** IRB 1096320
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
#### Secondary ID Infos
**ID:** 1138438
### Status Module
#### Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-12-11

**Type:** ACTUAL

**Last Update Submit Date:** 2017-11-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-02-14

**Type:** ESTIMATED

**Results First Submit Date:** 2014-01-01

**Results First Submit QC Date:** 2014-01-01

#### Start Date
**Date:** 2008-03

**Status Verified Date:** 2017-11

#### Study First Post Date
**Date:** 2008-03-13
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-06
**Study First Submit QC Date:** 2008-03-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of California, Davis

**Class:** OTHER

**Name:** University of Alabama at Birmingham

**Class:** OTHER

**Name:** Medical College of Wisconsin

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Missouri-Columbia

#### Responsible Party

**Investigator Affiliation:** University of Missouri-Columbia

**Investigator Full Name:** Brett Crist

**Investigator Title:** Assistant Professor, Co-Director of Trauma Services, Co-Director Trauma Fellowship, Department of Orthopaedic Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pelvic Fractures

- Acetabular Fractures

- Hip Fractures

**Keywords:**

- Fractures

- Pelvic bones

- Acetabulum

- Hip bones

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 115

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** will have the VAC device used for post-operative management of acetabular fractures and pelvic fractures.

**Intervention Names:**

- Device: VAC device

**Label:** VAC Device placement

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** will receive current traditional surgical wound management with daily dressing changes in post operative management of acetabular fractures and pelvic fractures.

**Intervention Names:**

- Other: Gauze dressing

**Label:** Gauze dressing

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VAC Device placement

**Description:** Vacuum Assisted Closure (VAC) device for surgical incision

**Name:** VAC device

**Other Names:**

- Wound Vac

- Negative pressure wound therapy (NPWT)

- Incisional Vac

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Gauze dressing

**Description:** Gauze dressing for surgical incision

**Name:** Gauze dressing

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Number of Participants With Wound Infections

**Time Frame:** Until wound healed, up to 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Columbia

**Country:** United States

**Facility:** University of Missouri

**State:** Missouri

**Zip:** 65212

#### Overall Officials

**Official 1:**

**Affiliation:** University of Missouri-Columbia

**Name:** Brett D Crist, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000005264

- Term: Femoral Fractures

- ID: D000025981

- Term: Hip Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M9696

- Name: Hip Fractures

- Relevance: HIGH

- As Found: Hip Fracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M8402

- Name: Femoral Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M23105

- Name: Hip Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000006620

- Term: Hip Fractures

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** VAC Device

**Description:** Vacuum Assisted Closure (VAC) device

Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision

**ID:** EG000

**Other Num Affected:** 3

**Other Num at Risk:** 49

**Serious Number Affected:** 15

**Serious Number At Risk:** 49

**Title:** VAC Device

**Group ID:** EG001

**Title:** Gauze Dressing

**Description:** Gauze Dressing

Gauze dressing: Gauze dressing for surgical incision

**ID:** EG001

**Other Num Affected:** 5

**Other Num at Risk:** 42

**Serious Number Affected:** 9

**Serious Number At Risk:** 42

**Title:** Gauze Dressing

**Frequency Threshold:** 0

#### Other Events

**Term:** urinary tract infection

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** ileus

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Regional Pain Syndrome

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** pneumomediastinum

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** hematoma

**Organ System:** Vascular disorders

**Source Vocabulary:** 

**Term:** malignancy, unrelated

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** 

**Term:** fall, no injury

**Organ System:** General disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** infection

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 42

**Term:** Perforated colon

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 42

**Term:** Pneumonia

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

**Term:** CVA

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

**Term:** implant failure

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

**Term:** prescription overdose

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Group ID:** EG001

**Num At Risk:** 42

**Term:** DVT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

**Term:** PE

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 49

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 42

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 55

**Group ID:** BG001

**Value:** 60

**Group ID:** BG002

**Value:** 115

**Units:** Participants

### Group

**ID:** BG000

**Title:** VAC Device

**Description:** Vacuum Assisted Closure (VAC) device

Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision

### Group

**ID:** BG001

**Title:** Gauze Dressing

**Description:** Gauze Dressing

Gauze dressing: Gauze dressing for surgical incision

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 19.6

**Value:** 47.2

#### Measurement

**Group ID:** BG001

**Spread:** 20.1

**Value:** 48.3

#### Measurement

**Group ID:** BG002

**Spread:** 19.9

**Value:** 47.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 31

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 43

#### Measurement

**Group ID:** BG001

**Value:** 41

#### Measurement

**Group ID:** BG002

**Value:** 84

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 55

#### Measurement

**Group ID:** BG001

**Value:** 60

#### Measurement

**Group ID:** BG002

**Value:** 115

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** cristb@health.missouri.edu
**Organization:** University of Missouri, Department of Orthopaedics
**Phone:** 573-882-6562
**Title:** Brett Crist, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Until wound healed, up to 1 year
**Title:** Number of Participants With Wound Infections
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Vacuum Assisted Closure (VAC) device

Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision
**ID:** OG000
**Title:** VAC Device
##### Group
**Description:** Gauze Dressing

Gauze dressing: Gauze dressing for surgical incision
**ID:** OG001
**Title:** Gauze Dressing
### Participant Flow Module
#### Group
**Description:** Vacuum Assisted Closure (VAC) device

Wound Vac: Vacuum Assisted Closure (VAC) device for surgical incision
**ID:** FG000
**Title:** VAC Device
#### Group
**Description:** Gauze Dressing

Gauze dressing: Gauze dressing for surgical incision
**ID:** FG001
**Title:** Gauze Dressing
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 55
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 60
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 42
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 18
**Has Results:** True