Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)
Adam Olson
Summary
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.
Description
Strategies to reduce the risk of acute wound complications have historically been mostly unsuccessful. In soft tissue sarcomas, a prior study showed that the use of indocyanine green (ICG) angiography at the time of wound closure was associated with a reduction in wound dehiscence and infection when compared to historical controls. Cutaneous colonization of S. aureus has been implicated in severe cases of radiation dermatitis. Some known risk factors for acute major wound complications for patients with sarcomas are anatomic location in the lower extremity, preoperative radiation therapy, larg…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 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) 3. Eligible for wide local excision 4. Eligible for external beam radiation therapy 5. Negative serum pregnancy test for women of childbearing potential \< 28 days prior to RT. 6. Informed consent signed and dated to participate in the study. 7. Willingness and ability to comply Exclusion Criteria: 1. Allergy to mupirocin and/or chlorhexidine 2. Activ…
Interventions
- Drug2% intranasal mupirocin ointment
Mupirocin 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.
- Drug4% chlorhexidine gluconate body cleanser
Chlorhexidine 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.
Location
- UPMC Hillman Cancer CentersPittsburgh, Pennsylvania