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Breast CancerNCT05823467

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

A study testing TMP-SMX DS and ciNPT dressing in people with Breast Cancer, run by University of Alberta at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
TMP-SMX DS and ciNPT dressing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesCanada
Study dates
26 Jun 2023to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female
  • > 18 years of age
  • Previous breast surgery and ipsilateral breast irradiation
  • Requiring repeat breast surgery

Who cannot join

  • 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
Show all 10Show fewer
  • Currently pregnant or breastfeeding, and
  • Marked hepatic damage
  • Severe renal insufficiency
  • Severe sensitivity or allergy to silicone adhesive

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Meadowlark Health Centre

    Edmonton, Alberta, T5R 5W9

  • St Thomas Surgical Clinic

    St. Albert, Alberta, T8N 7J6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
TMP-SMX DS, ciNPT dressing
Keywords
radiation, breast conservation surgery, recurrent breast cancer, wound VAC, postoperative antibiotics, post operative wound complications, repeat breast surgery
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMP-SMX DSDrug

    Also called Trimethoprim / Sulfamethoxazole

    Oral Antibiotic - used to treat post operative wound infections.

  • ciNPT dressingDevice

    Also called PICO dressing

    Negative pressure wound VAC placed on incision post operatively.

Study groups in NCT05823467
Study groupRoleWhat they receive
Post operative AntibioticExperimentalPatients in this arm will have a prescription for one week or post operative antibiotic ( 7-day course of TMP-SMX DS )
Receives: Drug: TMP-SMX DS
Post operative Wound VACExperimentalPatient will have a 7-day application of ciNPT dressing post operatively.
Receives: Device: ciNPT dressing
No InterventionNo interventionPatient will be treated as standard of care which is no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Wound Complication

    Assessment of rate of Wound complication with each intervention arm, immediately after intervention

    Measured: Post operative day 14 during follow up visit

Secondary outcomes (1)

  1. Adverse effects from intervention arm

    Will assess for any adverse reaction from each intervention as well as repeat hospital visit within 30 days (after the procedure and intervention)

    Measured: post procedure from post operative day 1 - post operative day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study start26 Jun 2023
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Why it stopped: Logistical Issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05823467
Sponsor's protocol ID
22-0241
Status last verified
Jul 2026
First submitted
17 Mar 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Edwards BL, Stukenborg GJ, Brenin DR, Schroen AT. Use of prophylactic postoperative antibiotics during surgical drain presence following mastectomy. Ann Surg Oncol. 2014 Oct;21(10):3249-55. doi: 10.1245/s10434-014-3960-7. Epub 2014 Aug 20.

    PubMed 25138078

  • Ferrando PM, Ala A, Bussone R, Bergamasco L, Actis Perinetti F, Malan F. Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings. Plast Reconstr Surg Glob Open. 2018 Jun 15;6(6):e1732. doi: 10.1097/GOX.0000000000001732. eCollection 2018 Jun.

    PubMed 30276035

  • Olsen MA, Nickel KB, Margenthaler JA, Wallace AE, Mines D, Miller JP, Fraser VJ, Warren DK. Increased Risk of Surgical Site Infection Among Breast-Conserving Surgery Re-excisions. Ann Surg Oncol. 2015;22(6):2003-9. doi: 10.1245/s10434-014-4200-x. Epub 2014 Oct 31.

    PubMed 25358666

  • Ruvalcaba-Limon E, Robles-Vidal C, Poitevin-Chacon A, Chavez-Macgregor M, Gamboa-Vignolle C, Vilar-Compte D. Complications after breast cancer surgery in patients treated with concomitant preoperative chemoradiation: A case-control analysis. Breast Cancer Res Treat. 2006 Jan;95(2):147-52. doi: 10.1007/s10549-005-9058-y. Epub 2005 Dec 1.

    PubMed 16319989

Questions about this trial

What is this clinical trial studying?

A study testing TMP-SMX DS and ciNPT dressing in people with Breast Cancer, run by University of Alberta at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Logistical Issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Wound Complication (time frame: Post operative day 14 during follow up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05823467, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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