Vacuum Assisted Closure as a Treatment for Open Fractures (VAC-OF)
Primary Purpose
Orthopaedic Traumatic Open Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Wound Dressing
VAC
Sponsored by
About this trial
This is an interventional treatment trial for Orthopaedic Traumatic Open Fractures focused on measuring Open Fractures, Vacuum Assisted Closure (VAC) device, Irrigation and Debridement
Eligibility Criteria
Inclusion Criteria:
- Patient who has sustained an open fracture that requires surgical irrigation and debridement.
- No gross clinical evidence of infection.
Exclusion Criteria:
- A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
- A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
- Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
- Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
- Pregnant women.
- Inability or unwillingness to comply with protocol.
- Patients or family members who are unable or unwilling to sign study informed consent.
Sites / Locations
- The University of Alabama at Birmingham, Orthopaedic Trauma
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1, A
2, B
Arm Description
Group A patients will have a standard dressing applied following initial treatment of their open fracture.
Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
Outcomes
Primary Outcome Measures
Healing of Orthopaedic Trauma Open Fractures
Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
Infections
Number of acute, delayed and deep wound infections.
Secondary Outcome Measures
Full Information
NCT ID
NCT00582361
First Posted
December 20, 2007
Last Updated
August 5, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
3M
1. Study Identification
Unique Protocol Identification Number
NCT00582361
Brief Title
Vacuum Assisted Closure as a Treatment for Open Fractures
Acronym
VAC-OF
Official Title
Vacuum Assisted Closure as a Treatment for Open Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
3M
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating traumatic wounds sustained associated with an open fracture.
Detailed Description
Soft tissue injury following an open fracture is a significant problem following surgical treatment of traumatic skeletal injuries. The soft tissue injury results from a combination of the initiating trauma and additional tissue injury during surgery. Current treatment includes open reduction and internal fixation versus external fixation, irrigation and debridement following admission, decreased activity (non weight bearing status on the injured extremity), maintaining the patient as an inpatient in the hospital, repeated irrigation and debridements (36-72 hours following the initial trauma) with concomitant wound culturing until which time it is determined that either delayed primary closure, or skin grafting with/without flap coverage should be attempted.
All patients in the study will be treated with the appropriate empiric antibiotic regimen until wound culture results justify modification for antibiotic sensitivity/resistance reasons. In general, barring patient allergy, the empiric antibiotic regimen will adhere to the Gustilo and Anderson classification as follows:
Grade I : Ancef Grade II : Ancef and Gentamicin or Zosyn Grade III : Ancef, Gentamicin or Zosyn, and add a Penicillin for grade IIIB open fractures.
All wounds will be assessed initially at admission following the Gustilo and Anderson classification for open fractures. Subsequent wound assessments in the operating room will be graded according to the following descriptive scale:
Type A wound: Abundant granulation tissue, ready for closure. Type B Wound: Granulation tissue present but inadequate for closure, Wound is clinically clean appearing. Type C Wound: No granulation tissue, no gross purulence. Type D Wound: Gross purulence/infected wound, no granulation tissue.
The outcome variables consist of the intraoperative and postoperative adverse device effects recorded in the medical record and on the study data collection form, time to wound closure, intraoperative and postoperative complications recorded in medical record and on the study data collection form. Clinical photographs of the wounds will be taken with a digital camera at the time of admission to the study, and during each subsequent trip to the operating room (every 48-72 hours). We will also record the injury severity score for all multiple trauma patients recorded at the time of injury in the medical record and on the study data collection form, and soft tissue score according to Gustillo and Anderson for open injuries in the medical record and on the study data collection form. Baseline serum albumin and total lymphocyte counts will be taken on admission to evaluate baseline nutritional and immunologic status at the time of injury. All patients in the Intensive Care Units will have daily weights, fluid balances, and nutritional intake documented. Resuscitation data will also be recorded from the trauma room, including fluids, blood, and base deficit. The effects will be measured by clinical examination and will be augmented with culture data for any wounds that require surgical intervention.
Patients who have an open fracture and who give informed consent to enter the study will be randomized into two groups. Group A will be patients treated with a return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until which time the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage. Group B will be patients treated with a VAC negative pressure device following the initial surgical irrigation and debridement. Group B patients will return to the operating room approximately 48 hours following the initial irrigation and debridement for VAC removal, wound cultures (qualitative and quantitative), repeat irrigation and debridement, and wound evaluation by the surgeon for possible delayed closure versus reapplication of the VAC device. Group B patients will also be returned to the operating room approximately every 48 hours thereafter for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until the wound is judged ready for coverage or closure by the surgeon.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopaedic Traumatic Open Fractures
Keywords
Open Fractures, Vacuum Assisted Closure (VAC) device, Irrigation and Debridement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1, A
Arm Type
Active Comparator
Arm Description
Group A patients will have a standard dressing applied following initial treatment of their open fracture.
Arm Title
2, B
Arm Type
Experimental
Arm Description
Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
Intervention Type
Procedure
Intervention Name(s)
Standard Wound Dressing
Intervention Description
Group A patients will have a standard dressing applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.
Intervention Type
Device
Intervention Name(s)
VAC
Other Intervention Name(s)
Vacuum Assisted Closure (VAC)
Intervention Description
Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture. They will return to the operating room approximately 48 hours following the initial trauma, and approximately every 48 hours thereafter, for irrigation and debridement and concomitant wound cultures (qualitative and quantitative) until such time as the wound is judged by the surgeon to be ready for either delayed primary closure or flap/skin graft coverage.
Primary Outcome Measure Information:
Title
Healing of Orthopaedic Trauma Open Fractures
Description
Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
Time Frame
from surgery to wound closure
Title
Infections
Description
Number of acute, delayed and deep wound infections.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who has sustained an open fracture that requires surgical irrigation and debridement.
No gross clinical evidence of infection.
Exclusion Criteria:
A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
Pregnant women.
Inability or unwillingness to comply with protocol.
Patients or family members who are unable or unwilling to sign study informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena L Stewart, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham, Orthopaedic Trauma
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16582806
Citation
Parrett BM, Matros E, Pribaz JJ, Orgill DP. Lower extremity trauma: trends in the management of soft-tissue reconstruction of open tibia-fibula fractures. Plast Reconstr Surg. 2006 Apr;117(4):1315-22; discussion 1323-4. doi: 10.1097/01.prs.0000204959.18136.36.
Results Reference
background
PubMed Identifier
15168301
Citation
Steiert AE, Partenheimer A, Schreiber T, Muehlberger T, Krettek C, Lahoda LU, Vogt PM. [The V.A.C. system (vacuum assisted closure) as bridging between primary osteosynthesis in conjunction with functional reconstructed of soft tissue--open fractures type 2 and type 3]. Zentralbl Chir. 2004 May;129 Suppl 1:S98-100. doi: 10.1055/s-2004-822658. German.
Results Reference
background
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Vacuum Assisted Closure as a Treatment for Open Fractures
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