Bacterial Decolonization Plus Intraoperative Angiography for Soft Tissue Sarcomas Receiving Preoperative Radiotherapy (CONCERTO)

NCT ID: NCT06712433

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-10-31

Brief 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.

Detailed 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, larger tumors, comorbidities (e.g., diabetes mellitus, tobacco usage, vascular disease, and obesity), tumors <3mm from skin surface, and the development of grade ≥ 2 acute radiation dermatitis. Both large tumors and lower extremity location can increase the likelihood of seroma formation, which can act as a nidus for infection and subsequent wound complication. Rationale for this trial includes prior studies of treating patients with a bacterial decolonization (BD) protocol of intranasal mupirocin ointment twice daily and chlorhexidine body cleanser once daily for 5 days prior to RT and repeated for 5 days every 2 weeks during radiation therapy that show significantly reduced risk of acute radiation dermatitis.

Conditions

Sarcoma,Soft Tissue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BD + Intranasal Mupirocin + Chlorhexidine

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

Group Type: EXPERIMENTAL

2% intranasal mupirocin ointment

Intervention Type: DRUG

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.

4% chlorhexidine gluconate body cleanser

Intervention Type: DRUG

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.

Interventions

2% 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.

Intervention Type: DRUG

4% 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.

Intervention Type: DRUG

Other Intervention Names

Hibiclens®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pittsburgh Cure Sarcoma

UNKNOWN

Sponsor Role: collaborator

Adam Olson

OTHER

Sponsor Role: lead

Responsible Party

Adam Olson

Assistant Professor, Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Adam M Olson, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Hillman Cancer Center

Locations

UPMC Hillman Cancer Centers

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Samantha Demko, RN

Role: CONTACT

albesl@upmc.edu

412-623-1400

Brieanna Marino, MS

Role: CONTACT

rowlesbm@upmc.edu

412-647-8258

Facility Contacts

Samantha Demko, RN

Role: primary

albesl@upmc.edu

412-623-1400

Brieanna Marino, MS

Role: backup

rowlesbm@upmc.edu

412-647-8258

Other Identifiers

HCC 24-080

Identifier Type: -

Identifier Source: org_study_id