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NCT Number: NCT02638298

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevana Dressing

Device

negative pressure wound therapy (NPWT) dressing

Standard Dry Gauze Dressing

Other

Standard Dry Gauze Dressing

Primary outcomes

  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.

    Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2015
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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