Post-Operative Care for Breast Surgery After Radiation

Recruiting at 1 trial location

Overseen By Mahmoud, BHSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Breastfeeding, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

105 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

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

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.

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

Group I: Post operative Wound VAC Experimental Treatment 1 Intervention

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

Group II: Post operative Antibiotic Experimental Treatment 1 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 Intervention Active Control 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Wound Management Using Negative Pressure Wound Therapy With Instillation and Dwell Time in a Cancer Care Setting. Isaac, DL.[2021]

In a retrospective analysis of 100 patients using negative pressure wound therapy with instillation and dwell time (NPWTi-d), significant wound healing was observed, with a 91% closure rate and a notable reduction in wound surface area after a median of 11 days.

The therapy effectively reduced the percentage of infected wounds from 72% to 46%, demonstrating its efficacy across various wound types and regardless of the topical solution used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bassetto, F., de Antoni, E., Rizzato, S., et al.[2021]

In a pilot study involving 40 gynecological oncology patients, the use of closed-incision negative pressure wound therapy (ciNPWT) did not significantly reduce the incidence of surgical site infections (SSIs) compared to conventional dressings, with infection rates of 21% for ciNPWT and 23% for controls.

Despite the ciNPWT group being assessed as at higher risk for SSIs using the American College of Surgeons risk calculator, the overall incidence of infections remained similar between the two groups after adjusting for risk factors, indicating that ciNPWT may not provide a prophylactic benefit in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-Incision Negative Pressure Wound management Following Midline Laparotomy in Gynecological Oncology Operations: A Feasibility Pilot Study. Yin, L., Lau, K., Mehra, G., et al.[2022]

In a case study of a 50-year-old immunocompromised woman, the addition of Caspofungin to the standard treatment of Trimethoprim-sulfamethoxazole (TMP-SMX) was necessary for improvement in her Pneumocystis jirovecii pneumonia (PCP).

This case highlights the potential for treatment failure with TMP-SMX alone in certain patients, suggesting that alternative therapies like Caspofungin may be beneficial in managing difficult cases of PCP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy with trimethoprim-sulfamethoxazole and caspofungin in a case of severe pneumocystis pneumonia. Koshy, R., Chen, T.[2020]

In a study of 80 patients with ventilator-associated pneumonia (VAP), trimethoprim-sulfamethoxazole (TMP-SMX) treatment did not lead to higher mortality rates at 30 days compared to those who did not receive TMP-SMX, indicating its efficacy as a treatment option.

TMP-SMX demonstrated a good safety profile, with no reported cases of severe allergies or Clostridium difficile infections, and did not contribute to the acquisition of multidrug-resistant bacteria during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trimetoprim-sulfametoxazole in ventilator-associated pneumonia: a cohort study. Strazzulla, A., Postorino, MC., Purcarea, A., et al.[2020]

In a study of 438 kidney transplant recipients, 47% required dose reductions of trimethoprim-sulfamethoxazole (TMP-SMX) due to adverse effects, but no cases of Pneumocystis jirovecii pneumonia (PcP) were reported, indicating that TMP-SMX remains effective even with reduced dosing.

The study found that living donor transplants were associated with a lower risk of hyperkalemia, while acute rejection increased the risk of leukopenia, suggesting that patient management strategies could be tailored based on these risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of prophylaxis for Pneumocystis jirovecii pneumonia involving trimethoprim-sulfamethoxazole dose reduction in kidney transplantation. Prasad, GVR., Beckley, J., Mathur, M., et al.[2020]

In a review of 132 patients treated with trimethoprim-sulfamethoxazole (TMP/SMX) for Pneumocystis pneumonia (PCP) prophylaxis in dermatology, 24.2% experienced adverse events, which is higher than previously reported rates.

The most common adverse event was thrombocytopenia, occurring in 12.5% of cases, suggesting that the standard TMP/SMX dosage may be too high for many patients, particularly those on corticosteroids or immunosuppressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of trimethoprim-sulfamethoxazole for the prophylaxis of Pneumocystis pneumonia in dermatology. Kokubu, H., Kato, T., Nishikawa, J., et al.[2021]

Aerosolized pentamidine (AP) was administered to 60 children with malignancy who were intolerant to TMP/SMX, and it was found to be well tolerated with only a 10% rate of adverse reactions during treatment.

None of the patients developed Pneumocystis carinii pneumonia (PCP) during the study, indicating that AP is an effective prophylactic option for preventing PCP in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerosolized pentamidine for the prevention of Pneumocystis carinii pneumonia in children with cancer intolerant or allergic to trimethoprim/sulfamethoxazole. Mustafa, MM., Pappo, A., Cash, J., et al.[2017]

In a study of 14,464 women with node-negative triple-negative breast cancer (TNBC), only 10.8% received post-mastectomy radiation therapy (PMRT), with usage significantly varying by tumor size (pT stage).

PMRT was associated with improved overall survival (OS) specifically in patients with T3 disease, but not in those with T1 or T2 disease, indicating that the benefits of PMRT may depend on the tumor stage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmastectomy radiation therapy for triple negative, node-negative breast cancer. Haque, W., Verma, V., Farach, A., et al.[2020]

In a study of 38,442 women with N2/N3 breast cancer, postmastectomy radiation therapy (PMRT) alone did not significantly improve overall survival compared to no treatment, indicating its limited impact when considered independently.

Patients receiving chemotherapy or hormonal therapy alone showed a reduced risk of death by 15% and 31%, respectively, while the combination of PMRT with these treatments did not provide a statistically significant survival advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Postmastectomy Radiation on Survival of AJCC pN2/N3 Breast Cancer Patients. Shi, Z., Peddi, P., Burton, G., et al.[2016]

Postmastectomy radiation therapy (PMRT) using proton pencil beam scanning (PBS) at Massachusetts General Hospital has shown effective target coverage and reduced radiation exposure to the heart and lungs, with over 25 patients successfully treated.

The PBS method provides improved nodal coverage and shorter treatment times compared to conventional photon/electron therapies, while maintaining accurate skin dose calculations within ±2%, demonstrating robustness against setup uncertainties and patient breathing motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to postmastectomy radiation therapy using scanned proton beams. Depauw, N., Batin, E., Daartz, J., et al.[2022]

In a study of 65 patients with post-mastectomy lymphedema, adding 600 mg/day of Robuvit® to standard comprehensive decongestive therapy (CTD) resulted in a significantly greater reduction in limb volume after 2 months compared to CTD alone (19.82% vs. 12.81%).

The Robuvit® group also experienced a more significant decrease in skin thickness and symptoms, with no reported side effects, suggesting it is a safe and effective supplement for managing lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation with Robuvit® in post-mastectomy post-radiation arm lymphedema. Belcaro, G., Dugall, M., Cotellese, R., et al.[2019]

In a study of 60 female patients, prophylactic fat injections significantly improved tissue thickness and quality in radiated breasts, indicating a reduction in post-radiation damage.

The findings suggest that fat injections enhance the outcomes of reconstructive surgery after post-mastectomy radiation therapy, leading to better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Prophylactic Lipofilling After Radiotherapy Compared to Non-Fat Injected Breasts: A Randomized, Objective Study. Gentilucci, M., Mazzocchi, M., Alfano, C.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Complex Wound Management Using Negative Pressure Wound Therapy With Instillation and Dwell Time in a Cancer Care Setting. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Closed-Incision Negative Pressure Wound management Following Midline Laparotomy in Gynecological Oncology Operations: A Feasibility Pilot Study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Combination therapy with trimethoprim-sulfamethoxazole and caspofungin in a case of severe pneumocystis pneumonia. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Trimetoprim-sulfametoxazole in ventilator-associated pneumonia: a cohort study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of prophylaxis for Pneumocystis jirovecii pneumonia involving trimethoprim-sulfamethoxazole dose reduction in kidney transplantation. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects of trimethoprim-sulfamethoxazole for the prophylaxis of Pneumocystis pneumonia in dermatology. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Aerosolized pentamidine for the prevention of Pneumocystis carinii pneumonia in children with cancer intolerant or allergic to trimethoprim/sulfamethoxazole. [2017]

11. Ireland pubmed.ncbi.nlm.nih.gov

Postmastectomy radiation therapy for triple negative, node-negative breast cancer. [2020]

12. Greece pubmed.ncbi.nlm.nih.gov

Effect of Postmastectomy Radiation on Survival of AJCC pN2/N3 Breast Cancer Patients. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

A novel approach to postmastectomy radiation therapy using scanned proton beams. [2022]

14. Italy pubmed.ncbi.nlm.nih.gov

Supplementation with Robuvit® in post-mastectomy post-radiation arm lymphedema. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Effects of Prophylactic Lipofilling After Radiotherapy Compared to Non-Fat Injected Breasts: A Randomized, Objective Study. [2022]