A Study of the Experimental Prevena™ device (Incisional Negative Pressure Wound Therapy) for Soft Tissue Sarcoma Wounds

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For questions and more information about this study, please contact the team using the information below.
Study coordinator
Name - Julia Martin
Email - jyhmartin@ucdavis.edu
Phone - (916) 734-8175

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: wound vacuum, wound therapy, sarcoma, cancer, cancer wound, sarcoma wound
Type: Device study
Target:
25 Participants
Investigator:
Description
Patients with sarcomas (tumor in bone or soft tissue) who receive radiation before surgery have a greater chance of complications in wound healing.

This research study will test a wound dressing called Negative Pressure Wound Therapy (NPWT). NPWT is a wound sponge attached to a gentle suction device. It is more effective at preventing infection of the surgical wound than standard dry gauze wound dressing.

The Prevena™ device (NPWT) is FDA approved for use on incisions. This will be considered the investigational dressing. The NPWT device is a foam sponge that is placed over the incision after surgery, and provides a low pressure gentle suction on the wound. It is sealed with an adhesive dressing.

The traditional standard dry gauze dressing will be considered the control dressing for this study
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Age>18
  • Willing to consent to randomization and able to participate in the study
  • Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection
  • Primary closure of wound
  • Patients scheduled for surgical resection

Exclusion criteria:

  • Flap coverage or skin graft
  • Patients scheduled for amputations as local control of their tumor
  • Sarcomas where radiation is not planned preoperatively
  • Repeat surgeries for oncologic reasons (positive margins)
  • Known allergy to adhesive tape
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for approximately 6 months following your operation. Your chart will be reviewed for up to 12 months from the date of your surgery.
Recruitment period
From Nov. 6, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Sarcoma
  • Cancer
  • Infectious Disease

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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