Clinical Trial: Vacuum Assisted Closure as a Treatment for Open Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vacuum Assisted Closure as a Treatment for Open Fractures

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 Summary:

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 granulat
Sponsor: University of Alabama at Birmingham

Current Primary Outcome:

• 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.

Original Primary Outcome: Healing of Orthopaedic Trauma Open Fractures [ Time Frame: Initial Treatment : 2-3 days; Postoperative: 0-5 days; Follow-up: 12 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alabama at Birmingham

Dates:
Date Received: December 20, 2007
Date Started: June 2001
Date Completion:
Last Updated: August 5, 2013
Last Verified: May 2012