Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-30 @ 5:45 AM
Study NCT ID:
NCT00582361
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vacuum Assisted Closure as a Treatment for Open Fractures
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Vacuum Assisted Closure as a Treatment for Open Fractures
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAC-OF
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: