VAC NPWT KCI Dressing Study

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Christopher Attinger, M.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT01366105
First received: May 26, 2011
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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 Intervention
Surgical Wound Infection
Device: V.A.C. by K.C.I.

Study Type: Interventional
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

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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)


Enrollment: 0
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

No further description is desired

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366105

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

No publications provided by Georgetown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Attinger, M.D., Chief of the Division of the Center for Wound Healing, Georgetown University
ClinicalTrials.gov Identifier: NCT01366105     History of Changes
Other Study ID Numbers: 2008-293
Study First Received: May 26, 2011
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Wound healing
Negative Pressure Wound Therapy
V.A.C.
Incision

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

ClinicalTrials.gov processed this record on August 18, 2014