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Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds

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ClinicalTrials.gov Identifier: NCT02638298
Recruitment Status : Recruiting
First Posted : December 23, 2015
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

The investigators will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.


Condition or disease Intervention/treatment Phase
Sarcoma Cancer Infectious Disease Device: Prevana Dressing Other: Standard Dry Gauze Dressing Not Applicable

Detailed Description:

Postoperative surgical site infections pose a significant challenge to the orthopaedic oncologist, especially in wounds that have been previously irradiated with neo adjuvant external beam radiation therapy (EBRT). There are many studies demonstrating the relatively high risk of wound complications after lower extremity sarcoma resection. Published data suggest that these preoperatively radiated wounds have a postoperative infection rate of 17%-44% with "traditional" dressings (e.g. dry gauze surgical dressings).

A prospective series of 190 patients and showed a wound complication risk of 35% in preoperative irradiated wounds. The morbidity associated with wound complications can range from moderate (prolonged dressing changes) to severe (life or limb threatening infection). Patients who develop wound complications have been shown to longer hospitalizations and higher costs [ref]. Anatomic location of the tumor has been shown to be a risk factor for the development of wound complications with lower extremities being higher risk than upper extremities. There are several published studies examining the effect of negative pressure wound therapy (NPWT) on high risk surgical wounds. Abdominal wound complications can be reduced with the use of incisional NPWT. In the orthopaedic literature the use of negative pressure incisional dressings have been shown to lower the risk of wound complications in total hip arthroplasty, acetabular fractures, and extremity fractures.

To our knowledge, there have not been any published studies on the utility of negative pressure wound therapy in previously irradiated soft tissue sarcoma wounds. The investigators feel that this high risk patient cohort could potentially benefit from reducing wound complications through NPWT and is an ideal population to study its effect.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds. A Prospective Randomized Clinical Trial
Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NPWT dressing Device: Prevana Dressing
negative pressure wound therapy (NPWT) dressing

Placebo Comparator: Standard dry gauze dressing Other: Standard Dry Gauze Dressing
Standard Dry Gauze Dressing




Primary Outcome Measures :
  1. Wound Complication Rate [ Time Frame: longitudinally up to 6 months postoperatively ]
    To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation.


Secondary Outcome Measures :
  1. Total Costs [ Time Frame: 6 months ]
    To estimate the on total cost of care and resource utilization in patients treated with negative pressure wound therapy and traditional dry dressings.



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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02638298


Contacts
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Contact: Monica E Baczko, MPA 843-792-8169 baczko@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Monica E Baczko, MPA    843-792-8169    baczko@musc.edu   
Principal Investigator: Lee R Leddy, MD         
Sponsors and Collaborators
Medical University of South Carolina
KCI USA, Inc.
Investigators
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Principal Investigator: Lee R Leddy, MD Medical University of South Carolins

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02638298     History of Changes
Other Study ID Numbers: Pro00028423
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Data safety and monitoring will be provided by the Hollings Cancer Center DSMC. This committee will serve for all sites. The DSMC meets 6 times a year and reviews all MUSC IRB adverse events, protocol deviations/violations, early stopping rules and internal audit results. The PI will be responsible for identifying, reviewing monthly, and reporting adverse events.

Individual participant data will not be shared between the sites. All data will be deidentified and linked with a code.


Additional relevant MeSH terms:
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Sarcoma
Communicable Diseases
Infection
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms