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VAC NPWT KCI Dressing Study

Primary Purpose

Surgical Wound Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
V.A.C. by K.C.I.
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound Infection focused on measuring Wound healing, Negative Pressure Wound Therapy, V.A.C., Incision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Dry Dressing

Negative Pressure Wound Therapy

Arm Description

Incisions that were dressed with a sterile dry dressing at end of operation.

Incisions dressed with a V.A.C. (NPWT) postoperatively.

Outcomes

Primary Outcome Measures

Incisional Dehiscence
any amount of incisional dehiscence noted post-operatively
Post operative infection
Post operative infection as noted by increased white count, clinical findings supporting infection (erythema, purulence, wound drainage)

Secondary Outcome Measures

Full Information

First Posted
May 26, 2011
Last Updated
April 1, 2013
Sponsor
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT01366105
Brief Title
VAC NPWT KCI Dressing Study
Official Title
Use of Negative Pressure Wound Therapy for At Risk Surgical Closures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
No further description is desired

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Wound healing, Negative Pressure Wound Therapy, V.A.C., Incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Dressing
Arm Type
No Intervention
Arm Description
Incisions that were dressed with a sterile dry dressing at end of operation.
Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
Incisions dressed with a V.A.C. (NPWT) postoperatively.
Intervention Type
Device
Intervention Name(s)
V.A.C. by K.C.I.
Other Intervention Name(s)
V.A.C. (Kinetic Concepts Incorporate)
Intervention Description
Negative Pressure Wound Therapy, Delivered by Vacuum Assisted Closure (KCI) across closed surgical incision at completion of surgery
Primary Outcome Measure Information:
Title
Incisional Dehiscence
Description
any amount of incisional dehiscence noted post-operatively
Time Frame
last post operative visit, up to 2 years
Title
Post operative infection
Description
Post operative infection as noted by increased white count, clinical findings supporting infection (erythema, purulence, wound drainage)
Time Frame
last post operative visit, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher E Attinger, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22549748
Citation
Masden D, Goldstein J, Endara M, Xu K, Steinberg J, Attinger C. Negative pressure wound therapy for at-risk surgical closures in patients with multiple comorbidities: a prospective randomized controlled study. Ann Surg. 2012 Jun;255(6):1043-7. doi: 10.1097/SLA.0b013e3182501bae.
Results Reference
derived

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VAC NPWT KCI Dressing Study

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