← Back to Search

Post-Operative Care for Breast Surgery After Radiation

N/A

Recruiting

Led By Azadeh Rajaee, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring repeat breast surgery

Previous breast surgery and ipsilateral breast irradiation

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial looks at whether women who have had breast surgery and radiation need post-op care. Researchers are comparing antibiotics, wound VAC, and no intervention to see what works best.

Who is the study for?

This trial is for women over 18 who have had breast surgery and radiation, and now need another breast surgery. They can't join if they're pregnant, breastfeeding, allergic to silicone adhesive or certain antibiotics, have severe liver or kidney issues, are under 18, male, or currently on other antibiotics.Check my eligibility

What is being tested?

The study tests if post-operative interventions help women at high risk of wound complications after repeat breast surgery. Participants will be randomly assigned to one of three groups: a week of antibiotics (TMP-SMX DS), a wound VAC dressing (ciNPT), or no intervention.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the antibiotic TMP-SMX DS such as rash and digestive issues; ciNPT dressing may cause skin irritation due to the adhesive.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need another breast surgery.

Select...

I have had breast surgery and radiation on the same side.

Select...

I am 18 years old or older.

Select...

I am female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post procedure from post operative day 1 - post operative day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post procedure from post operative day 1 - post operative day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and post procedure from post operative day 1 - post operative day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Wound Complication

Secondary outcome measures

Adverse effects from intervention arm

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Post operative Wound VACExperimental Treatment1 Intervention

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

Group II: Post operative AntibioticExperimental Treatment1 Intervention

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

Group III: No InterventionActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,072 Total Patients Enrolled

13 Trials studying Breast Cancer

2,178 Patients Enrolled for Breast Cancer

Azadeh Rajaee, MDPrincipal InvestigatorUniversity of Alberta

Media Library

Post operative Antibiotic Clinical Trial Eligibility Overview. Trial Name: NCT05823467 — N/A

Breast Cancer Research Study Groups: Post operative Antibiotic, Post operative Wound VAC, No Intervention

Breast Cancer Clinical Trial 2023: Post operative Antibiotic Highlights & Side Effects. Trial Name: NCT05823467 — N/A

Post operative Antibiotic 2023 Treatment Timeline for Medical Study. Trial Name: NCT05823467 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this study currently available?

"According to clinicaltrials.gov, this medical experiment commenced on June 26th 2023 and is still seeking participants. The information posted was last updated the following day."

Answered by AI

Is it feasible to enroll in this clinical research?

"This medical research necessitates that potential participants have breast cancer and are between 18 to 99 years of age. Ultimately, 105 people must be recruited for the trial."

Answered by AI

Are individuals aged 80 or younger admissible for this experiment?

"As listed in the inclusion criteria, this clinical trial is looking for participants between 18 and 99 years of age. Furthermore, there are 67 studies specifically targeting minors aged under 18 while 2548 surveys focus on senior citizens over 65."

Answered by AI

What is the total number of individuals participating in this medical experiment?

"Affirmative. The publicly-available information on clinicaltrials.gov reveals that recruitment for this medical study, which was first published June 26th 2023, is still active and ongoing. This endeavor seeks to enrol 105 people split across two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Azadeh Nikoo Rajaee 2023. "What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05823467.