This trial will investigate the combination of two low-cost, non-toxic strategies to assess whether they can reduce the risk of acute major wound complications in soft tissue sarcoma of the lower extremity. Intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to radiation therapy and repeated for 5 days every 2 weeks during radiation therapy may significantly reduce the risk of acute radiation dermatitis. That, along with use of indocyanine green (ICG) angiography at the time of wound closure.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Newly diagnosed soft tissue sarcoma arising from the lower extremity (defined as the tumor center arising at the level of the iliac crest or below)
Eligible for wide local excision
Eligible for external beam radiation therapy
Allergy to mupirocin and/or chlorhexidine
Active dermatologic condition in RT field
Tumor size > 32cm
Prior RT overlapping with fields
Single group
2% intranasal mupirocin ointment
DrugMupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.
4% chlorhexidine gluconate body cleanser
DrugChlorhexidine Gluconate (CHG) Solution Antiseptic Skin Cleanser solution is a topical skin cleanser that keeps working after it is used. CHG is a strong antiseptic (liquid used to kill germs and bacteria) that lowers the risk of infection.
Incidence and type of acute major wound complications
Incidence and type of acute major wound complications: One or more of the following events occurring within 4 months of index sarcoma surgery including: 1). A secondary operation under general or regional anesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), 2). Wound management without secondary operation, such, An invasive procedure without general or regional anesthesia (such as aspiration of seroma), Readmission for wound care such as intravenous antibiotics, or Persistent deep packing for 120 days or longer.
1-year Local control
Local control is defined as the proportion of patients without clinical evidence of local recurrence. This will be reported as will a cumulative incidence curve of local failures, considering using death as a competing risk, using the cumulative incidence function method.
2-year Local control
Local control is defined as the proportion of patients without clinical evidence of local recurrence. This will be reported as will a cumulative incidence curve of local failures, considering using death as a competing risk, using the cumulative incidence function method.
Progression-free survival (PFS)
Median number of months from start of treatment until the date of disease progression or death from any cause.
Overall survival (OS)
Median number of months from start of treatment until death from any cause.
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Adam Olson
Lead sponsor
University of Pittsburgh
Sponsor institution
Pittsburgh Cure Sarcoma
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
