Title The Effect of INPWT on Wound Complications and Clinical Outcomes Following Lower Extremity Sarcoma Surgery in Patients Treated With Preoperative Radiation Therapy: A Multicentre Randomized Controlled Trial
Protocole ID 20170154
ClinicalTrials.gov ID NCT03175718
Cancer Type(s) Sarcoma
Phase Other
Stage
Study Type Treatment
Drug
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   HOPITAL GENERAL DE MONTREAL
      1650 Avenue Cedar, MontrĂ©al, QC, H3G 1A4
City
Principal Investigator Dr. Robert Turcotte
Coordinator Mireille Dessureault
514-934-1934 poste 43022
Status Recruiting
Activation Date
Eligibility Criteria
  • Patients 18 years of age and older and are able to provide written consent.
  • Patients with lower extremity soft tissue sarcoma confirmed by tissue pathology.Each patient must have local cross sectional imaging (CT or MRI) and a staging CT chest.
  • Patients eligible for treatment with preoperative radiation therapy followed by limb salvage surgery.
  • Patients for which a primary closure must be attained at the time of surgery.
  • Patient must be available for postoperative follow-up at the treating center.
Exclusion Criteria
  • Patients who are less than 18 years of age.
  • Patients with a benign disease or who have had previous surgery or radiation therapy to the affected area.
  • Patients who underwent surgical amputation
  • Patients in which primary closure was not achieved (including free flaps and split thickness skin grafts).
  • Patients with a life expectancy less than 120 days.
  • Patients who have an allergy or sensitivity to adhesive dressings.
  • Other major medical condition preventing safe usage of the INPWT dressing.