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Can a simple antibiotic or wound VAC prevent complications after repeat breast surgery?

NCT ID NCT05823467

Disease control Sponsor: University of Alberta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study looks at women who have had breast surgery and radiation before and need another breast surgery. Because radiation increases the risk of wound complications, the researchers want to see if giving a week of antibiotics or using a wound VAC (a special dressing) helps prevent these problems compared to no extra treatment. About 105 women will be randomly assigned to one of three groups to find out which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trimethoprim/Sulfamethoxazole (antibiotic) and ciNPT dressing (wound VAC)
What this could lead to
If it works, this could show that a simple antibiotic or wound VAC reduces wound complications after repeat breast surgery in women who had radiation.
What could go wrong
This is a small, early-phase trial with only 105 participants, so results may not apply to everyone. Antibiotics can cause side effects like allergic reactions or diarrhea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Started

Jun 2023

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Meadowlark Health Centre

    Edmonton, Alberta, T5R 5W9, Canada

  • St Thomas Surgical Clinic

    St. Albert, Alberta, T8N 7J6, Canada

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