VAC NPWT KCI Dressing Study
In this study, the investigators propose using negative pressure wound therapy (NPWT) to aid in wound healing along the lines of closure for lower extremity amputation and complex abdominal wounds. This study is designed to be a prospective, randomized clinical trial to evaluate the effectiveness of NPWT versus accepted standard surgical dressings on these wounds. Study participants will be randomized to one of the two treatment groups (NPWT vs. standard dressing) prior to surgery, and will be followed in the post operative period to monitor the effects on their surgical closures. The experimental group will consist of participants receiving NPWT and will have a Vacuum Assisted Closure (V.A.C., KCI inc.) device placed intra-op along the line of closure. The control group will receive a standard surgical dry sterile dressing. The surgical closures will be assessed after three days of treatment as well as the first outpatient post-op visit and any subsequent visits through the following 6 months. By doing so, the investigators hope to demonstrate the utility of NPWT on difficult, at risk surgical closures. Additionally, the investigators hope to show a difference in clinical outcome of incisions treated by NPWT over our current standard technique.
All patients in the principal and co-investigators practice who are scheduled to undergo lower extremity amputation or complex abdominal closure will be eligible for enrollment in this prospective randomized study. There are no exclusion criteria. Informed consent will be obtained pre-operatively. Data collection will include basic demographic data, disease history, past medical and social history as well key data relating to wound healing (infection, wound dehiscence or breakdown) and hospital course (length of stay, operative complications). The investigators will use simple statistical methods (ANOVA and chi-squared analysis) to compare surgical wound healing between the two populations. The only deviation from current standard of care in these populations includes utilizing a V.A.C. system on the closure line of the experimental group versus the standard dry sterile dressing.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of Negative Pressure Wound Therapy for At Risk Surgical Closures|
- Incisional Dehiscence [ Time Frame: last post operative visit, up to 2 years ] [ Designated as safety issue: No ]any amount of incisional dehiscence noted post-operatively
- Post operative infection [ Time Frame: last post operative visit, up to 2 years ] [ Designated as safety issue: No ]Post operative infection as noted by increased white count, clinical findings supporting infection (erythema, purulence, wound drainage)
|Study Start Date:||August 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
No Intervention: Dry Dressing
Incisions that were dressed with a sterile dry dressing at end of operation.
Experimental: Negative Pressure Wound Therapy
Incisions dressed with a V.A.C. (NPWT) postoperatively.
Device: V.A.C. by K.C.I.
Negative Pressure Wound Therapy, Delivered by Vacuum Assisted Closure (KCI) across closed surgical incision at completion of surgery
Other Name: V.A.C. (Kinetic Concepts Incorporate)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366105
|United States, District of Columbia|
|Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Christopher E Attinger, MD||Georgetown University|