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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sarcoma, Cancer, Infectious Disease

Intervention / Treatment
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* Device: Prevana Dressing
* Other: Standard Dry Gauze Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPWT dressing<br> | Device: Prevana Dressing<br>* negative pressure wound therapy (NPWT) dressing<br>|
| Placebo Comparator: Standard dry gauze dressing<br> | Other: Standard Dry Gauze Dressing<br>* Standard Dry Gauze Dressing<br>|

What is the study measuring?
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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 |