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

September 3, 2025 updated by: University of Alberta

What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 5W9
        • Recruiting
        • Meadowlark Health Centre
        • Contact:
      • St. Albert, Alberta, Canada, T8N 7J6
        • Recruiting
        • St Thomas Surgical Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post operative Antibiotic
Patients in this arm will have a prescription for one week or post operative antibiotic ( 7-day course of TMP-SMX DS )
Drug: TMP-SMX DS
Oral Antibiotic - used to treat post operative wound infections.
Other Names:
  • Trimethoprim / Sulfamethoxazole
Experimental: Post operative Wound VAC
Patient will have a 7-day application of ciNPT dressing post operatively.
Device: ciNPT dressing
Negative pressure wound VAC placed on incision post operatively.
Other Names:
  • PICO dressing
No Intervention: No Intervention
Patient will be treated as standard of care which is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Wound Complication
Time Frame: Post operative day 14 during follow up visit
Assessment of rate of Wound complication with each intervention arm, immediately after intervention
Post operative day 14 during follow up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects from intervention arm
Time Frame: post procedure from post operative day 1 - post operative day 30
Will assess for any adverse reaction from each intervention as well as repeat hospital visit within 30 days (after the procedure and intervention)
post procedure from post operative day 1 - post operative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Azadeh Rajaee, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 8, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0241

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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