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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT

NCT01664091

Breast Cancer

COMPLETED NA

Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

NCT00005957

Breast Cancer

COMPLETED NA

ciNPT in Autologous DIEP Flap Breast Reconstruction

NCT05907941

Breast Cancer Wound Dehiscence, Surgical

NOT_YET_RECRUITING NA

Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

NCT00845078

Breast Radiotherapy Aesthetics +2 more

WITHDRAWN

Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction

NCT03764943

Wound Complication Wound Heal Complications Wound +4 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 )

Group Type EXPERIMENTAL

TMP-SMX DS

Intervention Type DRUG

Oral Antibiotic - used to treat post operative wound infections.

Post operative Wound VAC

Patient will have a 7-day application of ciNPT dressing post operatively.

Group Type EXPERIMENTAL

ciNPT dressing

Intervention Type DEVICE

Negative pressure wound VAC placed on incision post operatively.

No Intervention

Patient will be treated as standard of care which is no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TMP-SMX DS

Oral Antibiotic - used to treat post operative wound infections.

Intervention Type DRUG

ciNPT dressing

Negative pressure wound VAC placed on incision post operatively.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Trimethoprim / Sulfamethoxazole PICO dressing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes