Vacuum Assisted Closure as a Treatment for Open Fractures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Healing of Orthopaedic Trauma Open Fractures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1, A
Group A patients will have a standard dressing applied following initial treatment of their open fracture.
Intervention: Standard Wound Dressing (Procedure)
2, B
Group B patients will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
Intervention: VAC (Device)
Outcomes
Primary Outcomes
Healing of Orthopaedic Trauma Open Fractures
Time Frame: from surgery to wound closure
Healing of the open wound following orthopaedic trauma open fracture surgery was measured in days. (The wound has healed adequately to permit closure)
Infections
Time Frame: Up to 12 months
Number of acute, delayed and deep wound infections.
Secondary Outcomes
No secondary outcomes reported