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

NCT05823467 | Terminated

• 1 other identifier: 22-0241
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

radiation; breast conservation surgery; recurrent breast cancer; wound VAC; postoperative antibiotics; post operative wound complications; repeat breast surgery

Outcome Measures

Primary Outcomes (1)

• Rate of Wound Complication

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

  Post operative day 14 during follow up visit

Secondary Outcomes (1)

• Adverse effects from intervention arm

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

Study Arms (3)

Post operative Antibiotic

EXPERIMENTAL

Patients in this arm will have a prescription for one week or post operative antibiotic ( 7-day course of TMP-SMX DS )

Drug: TMP-SMX DS

Post operative Wound VAC

EXPERIMENTAL

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

Device: ciNPT dressing

No Intervention

NO INTERVENTION

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

Interventions

TMP-SMX DS DRUG

Oral Antibiotic - used to treat post operative wound infections.

Also known as: Trimethoprim / Sulfamethoxazole

Post operative Antibiotic

ciNPT dressing DEVICE

Negative pressure wound VAC placed on incision post operatively.

Also known as: PICO dressing

Post operative Wound VAC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Patients with Breast Cancer - male breast cancer will present a confounding variable
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

Meadowlark Health Centre

Edmonton, Alberta, T5R 5W9, Canada

Location

St Thomas Surgical Clinic

St. Albert, Alberta, T8N 7J6, Canada

Location

Related Publications (4)

• 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.

  PMID: 25138078 BACKGROUND

• 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.

  PMID: 30276035 BACKGROUND

• 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.

  PMID: 25358666 BACKGROUND

• 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.

  PMID: 16319989 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Azadeh Rajaee, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 21, 2023
• Study Start: June 26, 2023
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

CA (2)