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VAC NPWT KCI Dressing Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01366105
Recruitment Status : Withdrawn
First Posted : June 3, 2011
Last Update Posted : April 4, 2013
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University

Brief Summary:

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.

Condition or disease Intervention/treatment
Surgical Wound Infection Device: V.A.C. by K.C.I.

Detailed Description:
No further description is desired

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Negative Pressure Wound Therapy for At Risk Surgical Closures
Study Start Date : August 2008
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Incisional Dehiscence [ Time Frame: last post operative visit, up to 2 years ]
    any amount of incisional dehiscence noted post-operatively

  2. Post operative infection [ Time Frame: last post operative visit, up to 2 years ]
    Post operative infection as noted by increased white count, clinical findings supporting infection (erythema, purulence, wound drainage)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients presenting to wound center undergoing wound treatment with expected closure of wounds including: Midfoot amputations, below knee amputations, knee disarticulations, above knee amputations, and trunk wounds
  • wounds must be closed primarily without the use of grafts

Exclusion Criteria:

  • any patient <18 years old
  • any patient whose wound is unable to be closed primarily

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01366105

United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Principal Investigator: Christopher E Attinger, MD Georgetown University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christopher Attinger, M.D., Chief of the Division of the Center for Wound Healing, Georgetown University Identifier: NCT01366105     History of Changes
Other Study ID Numbers: 2008-293
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Christopher Attinger, M.D., Georgetown University:
Wound healing
Negative Pressure Wound Therapy

Additional relevant MeSH terms:
Wound Infection
Surgical Wound
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes