Clinical trial · Interventional
Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)
Bacterial Decolonization Plus Intraoperative Indocyanine Green Angiography for Soft Tissue Sarcomas of the Lower Extremity Receiving Preoperative Radiotherapy (CONCERTO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma,Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2% intranasal mupirocin ointment | Drug | — | UNRESOLVED |
| 4% chlorhexidine gluconate body cleanser | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BD + Intranasal Mupirocin + Chlorhexidine
- description
- Bacterial Decolonization with 2% intranasal mupirocin ointment twice daily (BID) and 4% chlorhexidine gluconate body cleanser, once daily (QD) for 5 consecutive days prior to RT, and this will be repeated for 5 days every 2 weeks throughout Radiation Therapy. The treatment will also be administered for 5 consecutive days prior to index surgery. RT can be prescribed in one of three dose/fractionation regimens at the investigator's discretion: 50 Gy in 25 fractions, 42.75 Gy in 15 fractions, or 36 Gy in 18 fractions
- interventionNames
- Drug: 2% intranasal mupirocin ointment
- Drug: 4% chlorhexidine gluconate body cleanser
Primary outcomes (1)
- measure
- Incidence and type of acute major wound complications
- timeFrame
- Up to 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. Active dermatologic condition in RT field 3. Tumor size \> 32cm 4. Prior RT overlapping with fields 5. Concurrent/prior invasive malignancy that could potentially interfere with proposed treatment. Individual cases can be discussed with PI prior to registration
References
Publications (0)
Data not yet available