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

Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds. A Prospective Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Cancer; Infectious Disease
• Intervention / Treatment: Device: Prevana Dressing; Other: Standard Dry Gauze Dressing

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna E Williams, MA; Phone Number: 843-792-6639; Email: wiljenna@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Jenna E Williams, MA; Phone Number: 843-792-6639; Email: wiljenna@musc.edu
      • Principal Investigator: Lee R Leddy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Complication Rate	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.	longitudinally up to 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Costs	To estimate the on total cost of care and resource utilization in patients treated with negative pressure wound therapy and traditional dry dressings.	6 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: 3M
• Investigators: Principal Investigator: Lee R Leddy, MD, Medical University of South Carolins

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimated): December 23, 2015

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Sarcoma; Infections; Communicable Diseases
• Other Study ID Numbers: Pro00028423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.