What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• Female

• \> 18 years of age

• Previous breast surgery and ipsilateral breast irradiation

• Requiring repeat breast surgery

Locations
Other Locations
Canada
Meadowlark Health Centre
RECRUITING
Edmonton
St Thomas Surgical Clinic
RECRUITING
St. Albert
Contact Information
Primary
Mahmoud, BHSc
sheharza@ualberta.ca
780-486-5030
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 105
Treatments
Experimental: Post operative Antibiotic
Patients in this arm will have a prescription for one week or post operative antibiotic ( 7-day course of TMP-SMX DS )
Experimental: Post operative Wound VAC
Patient will have a 7-day application of ciNPT dressing post operatively.
No_intervention: No Intervention
Patient will be treated as standard of care which is no intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov