105 Participants Needed

Post-Operative Care for Breast Surgery After Radiation

Recruiting at 1 trial location
MB
Overseen ByMahmoud, BHSc
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently on antibiotic therapy for other reasons, you cannot participate in this trial.

What data supports the effectiveness of the treatment ciNPT dressing, Negative Pressure Wound Therapy (NPWT) dressing, and Vacuum-Assisted Closure (VAC) dressing for post-operative care in breast surgery after radiation?

Research shows that negative pressure wound therapy (NPWT) can help promote healing in complex wounds, especially in patients with delayed healing due to chemotherapy and radiation. However, studies specifically on closed-incision negative pressure therapy (ciNPT) in oncological breast surgery have not shown a significant reduction in surgical site infections compared to standard dressings.12345

Is trimethoprim-sulfamethoxazole (TMP-SMX) generally safe for humans?

Trimethoprim-sulfamethoxazole (TMP-SMX) is generally considered safe for humans, but it can cause adverse effects in some cases. Studies have shown that while it is well-tolerated by many, some people may experience side effects like thrombocytopenia (low platelet count) and allergic reactions, especially when used with other medications.678910

How does the treatment for post-operative care after breast surgery differ from other treatments?

The treatment involves the use of fat injections, which are unique because they help reduce post-radiation damage to soft tissue and implants, unlike traditional methods that do not address this specific issue.1112131415

What is the purpose of this trial?

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.

Research Team

AR

Azadeh Rajaee, MD

Principal Investigator

University of Alberta

Eligibility Criteria

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.

Inclusion Criteria

I need another breast surgery.
I have had breast surgery and radiation on the same side.
I am female.

Exclusion Criteria

I am currently taking antibiotics for a different health issue.
I have anemia caused by not having enough folate.
I have significant liver damage.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into three arms: post-operative antibiotics for one week, wound VAC for one week, or no intervention

1 week
1 visit (in-person)

Follow-up

Participants are monitored for wound complications and adverse effects of interventions

4-6 weeks
2 visits (in-person)

Extended Follow-up

Participants are monitored for any repeat hospital visits or extended complications

up to 30 days post-procedure

Treatment Details

Interventions

  • ciNPT dressing
  • TMP-SMX DS
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Findings from Research

In a study of 37 patients undergoing oncological breast surgery, the use of closed incision negative pressure therapy (ciNPT) resulted in only 4% of surgeries experiencing complications, compared to 45% in the standard care group, highlighting its efficacy in reducing postsurgical complications.
Patients using ciNPT reported significantly better outcomes in terms of scar quality and overall satisfaction, suggesting that ciNPT is a reliable and adaptable dressing option for patients with multiple risk factors.
Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings.Ferrando, PM., Ala, A., Bussone, R., et al.[2022]
Prophylactic negative pressure wound therapy (pNPWT) significantly reduces the incidence of surgical site infections (SSIs) compared to conventional wound dressings, with a notable odds ratio of 0.56 in randomized controlled trials and 0.30 in observational studies, translating to a reduction in SSI rates from 140 to 83 and from 106 to 34 per 1000 patients, respectively.
The evidence supporting pNPWT's effectiveness is considered low quality, and while it shows consistent benefits across various types of surgeries, the results were not significant for orthopedic or trauma surgeries.
A systematic review and meta-analysis including GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clean and contaminated surgery.De Vries, FEE., Wallert, ED., Solomkin, JS., et al.[2022]
In a case series of 6 cancer patients with complex wounds, negative pressure wound therapy with instillation and dwell time (NPWTi-d) significantly improved wound healing indicators, including reduced slough and increased granulation tissue, over a treatment period of 1 to 2 weeks.
NPWTi-d effectively cleansed the wound bed and created a moist environment that facilitated healing, leading to successful wound closure or transition to conventional NPWT before patient discharge.
Complex Wound Management Using Negative Pressure Wound Therapy With Instillation and Dwell Time in a Cancer Care Setting.Isaac, DL.[2021]

References

Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings. [2022]
A systematic review and meta-analysis including GRADE qualification of the risk of surgical site infections after prophylactic negative pressure wound therapy compared with conventional dressings in clean and contaminated surgery. [2022]
Complex Wound Management Using Negative Pressure Wound Therapy With Instillation and Dwell Time in a Cancer Care Setting. [2021]
Management of Acute and Chronic Wounds Using Negative Pressure Wound Therapy With Instillation and Dwell Time: A Retrospective Review of a 100-Patient Cohort in Padova, Italy. [2021]
Closed-Incision Negative Pressure Wound management Following Midline Laparotomy in Gynecological Oncology Operations: A Feasibility Pilot Study. [2022]
Combination therapy with trimethoprim-sulfamethoxazole and caspofungin in a case of severe pneumocystis pneumonia. [2020]
Trimetoprim-sulfametoxazole in ventilator-associated pneumonia: a cohort study. [2020]
Safety and efficacy of prophylaxis for Pneumocystis jirovecii pneumonia involving trimethoprim-sulfamethoxazole dose reduction in kidney transplantation. [2020]
Adverse effects of trimethoprim-sulfamethoxazole for the prophylaxis of Pneumocystis pneumonia in dermatology. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Aerosolized pentamidine for the prevention of Pneumocystis carinii pneumonia in children with cancer intolerant or allergic to trimethoprim/sulfamethoxazole. [2017]
Postmastectomy radiation therapy for triple negative, node-negative breast cancer. [2020]
Effect of Postmastectomy Radiation on Survival of AJCC pN2/N3 Breast Cancer Patients. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
A novel approach to postmastectomy radiation therapy using scanned proton beams. [2022]
Supplementation with Robuvit® in post-mastectomy post-radiation arm lymphedema. [2019]
Effects of Prophylactic Lipofilling After Radiotherapy Compared to Non-Fat Injected Breasts: A Randomized, Objective Study. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security