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

• ClinicalTrials.gov Identifier: NCT02638298
• Recruitment Status: Recruiting
• First Posted: December 23, 2015
• Last Update Posted: June 1, 2020
• Sponsor: Medical University of South Carolina
• Collaborator: KCI USA, Inc.
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Lee R Leddy, MD; Medical University of South Carolins

More Information

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT02638298
• Other Study ID Numbers: Pro00028423
• First Posted: December 23, 2015
• Last Update Posted: June 1, 2020
• Last Verified: May 2020

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:

Communicable Diseases; Infection; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms