What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery

Trial Title: What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery

NCT ID: NCT05823467

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Trimethoprim
Sulfamethoxazole

Conditions: Keywords:
radiation
breast conservation surgery
recurrent breast cancer
wound VAC
postoperative antibiotics
post operative wound complications
repeat breast surgery

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This study will randomize patients to three arms - patients will either be randomized to post operative antibiotic arm (1 week), post operative wound VAC arm (1 week), or no intervention.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TMP-SMX DS
Description: Oral Antibiotic - used to treat post operative wound infections.
Arm group label: Post operative Antibiotic

Other name: Trimethoprim / Sulfamethoxazole

Intervention type: Device
Intervention name: ciNPT dressing
Description: Negative pressure wound VAC placed on incision post operatively.
Arm group label: Post operative Wound VAC

Other name: PICO dressing

Summary: This study will look at whether females who have previously had breast surgery and radiation and are undergoing repeat breast surgery require any post operative interventions. The reason the investigators are conducting this study is because females who have undergone breast radiation are at higher risk of wound complications following breast surgery. The investigators will randomize recruited female participants into three arms, one which is post operative antibiotics for one week, one which is a wound VAC, and one which is no intervention. The investigators goal is to identify whether these patients will require any postoperative interventions.

Detailed description: Background: The 10-year local recurrence rate for breast cancer following breast conserving surgery (BCS) and radiation therapy (RT) is estimated around 19% for which the standard of care is completion mastectomy. This represents a growing population of patients with prior irradiation undergoing repeat oncologic surgery. Patients undergoing surgery after RT have been shown to be at higher risk for wound complications such as surgical site infection (SSI), dehiscence, and skin necrosis. The average rate of SSI following major breast surgery is estimated at 5%, whereas it has been reported over 30% in irradiated patients. However, the data remains sparse dedicated to mitigating early wound complications in this patient population with guidelines or recommendations that exist for prophylactic measures. A retrospectively review analyzed SSI rate in patients undergoing mastectomy without reconstruction and found a statistically significant reduction in SSI rate with post-operative antibiotics in the subset of patients with previous RT (30.8% to 3.6%). In another study of a prospectively followed cohort of high-risk patients undergoing breast cancer surgery, a subset of whom had previous RT, these patients were found to have a significant reduction from 45% to 4% for all wound complications (no reported SSI) with closed incision negative pressure wound therapy (ciNPT) and post-operative antibiotics. Therefore, the investigators hypothesize that patients with prior BCS and RT undergoing repeat oncologic breast surgery would benefit from post-operative prophylactic therapy to reduce early wound complications. Retrospective analyses and prospective cohort studies have demonstrated potential benefit; however, a high quality RCT is warranted to analyze our research question. Study Design: The investigator's primary objective will be to evaluate the effect of a 7-day course of TMP-SMX DS and 7-day application of ciNPT dressing (PICO) on the rate of early wound complications in this patient population. This study will be designed as an unblinded block randomized controlled trial with three arms: 1) standard of care 2) post-operative antibiotics 3) ciNPT. Participants will be recruited by surgeons at the Meadowlark and Sturgeon surgical clinics. Data will be collected via paper forms or Connect Care at 1-2 week and 4-6 week post-operative visits. The primary outcome measure will be wound complications (SSI, dehiscence, skin necrosis). Secondary outcomes will include adverse effects of antibiotics or ciNPT therapy, and other post-operative complications (extended antibiotic therapy, re-operation, admission to hospital). Impact: The investigators hope the results of this trial will demonstrate benefit of prophylactic antibiotics and/or ciNPT to decrease wound complications in this patient population. This will have the potential to create recommendations for a post-operative prophylactic regimen to inform future guidelines and practice in oncologic breast surgery.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Female - > 18 years of age - Previous breast surgery and ipsilateral breast irradiation - Requiring repeat breast surgery Exclusion Criteria: - Male - <18 years of age, - Currently on antibiotic therapy for other indications - Known hypersensitivity to trimethoprim or sulfonamides, - History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides - Documented megaloblastic anemia due to folate deficiency - Currently pregnant or breastfeeding, and - Marked hepatic damage - Severe renal insufficiency - Severe sensitivity or allergy to silicone adhesive

Gender: Female

Gender based: Yes

Gender description: Patients with Breast Cancer - male breast cancer will present a confounding variable

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Meadowlark Health Centre

Address:
City: Edmonton
Zip: T5R 5W9
Country: Canada

Status: Recruiting

Contact:
Last name: Azadeh Rajaee, MD
Email: rajaee@ualberta.ca

Facility:
Name: St Thomas Surgical Clinic

Address:
City: St. Albert
Zip: T8N 7J6
Country: Canada

Status: Recruiting

Contact:
Last name: Azadeh Rajaee, MD
Email: rajaee@ualberta.ca

Start date: June 26, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: University of Alberta
Agency class: Other

Source: University of Alberta

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05823467