RecruitingNot ApplicableNCT05823467

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

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


Sponsor

University of Alberta

Enrollment

105 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the best antibiotic to use before repeat breast surgery in women who have previously had both breast surgery and radiation therapy to the same breast. Prior radiation increases the risk of infection with repeat surgery, and researchers want to find out which antibiotic (or combination) works best to prevent post-operative infections. **You may be eligible if...** - You are a woman over 18 years old - You have previously had breast surgery AND radiation therapy to the same breast - You now need another breast surgery on that same breast **You may NOT be eligible if...** - You are currently taking antibiotics for another reason - You are allergic to trimethoprim or sulfonamides - You have a history of drug-induced immune thrombocytopenia (low platelets from certain antibiotics) - You have severe liver or kidney disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTMP-SMX DS

Oral Antibiotic - used to treat post operative wound infections.

DEVICEciNPT dressing

Negative pressure wound VAC placed on incision post operatively.


Locations(2)

Meadowlark Health Centre

Edmonton, Alberta, Canada

St Thomas Surgical Clinic

St. Albert, Alberta, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05823467


Related Trials