Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
FEMALE
Healthy Volunteers
NCT05823467

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

Led by University of Alberta · Updated on 2025-09-05

105

Participants Needed

2

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Over 18 years of age
  • Previous breast surgery and ipsilateral breast irradiation
  • Requiring repeat breast surgery
Not Eligible

You will not qualify if you...

  • Male
  • Under 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
  • Marked hepatic damage
  • Severe renal insufficiency
  • Severe sensitivity or allergy to silicone adhesive

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Meadowlark Health Centre

Edmonton, Alberta, Canada, T5R 5W9

Actively Recruiting

2

St Thomas Surgical Clinic

St. Albert, Alberta, Canada, T8N 7J6

Actively Recruiting

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Research Team

M

Mahmoud, BHSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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