Impact of a surgical sealing patch on lymphatic drainage after axillary dissection for breast cancer. Multicenter randomized phase III SAKK 23/13 trial

Introduction:

We aimed at investigating the impact of TachoSil® on drainage after axillary dissection for breast cancer.

Methods:

In this phase 3 superiority trial, we randomized patients undergoing breast conserving surgery at 14 Swiss breast centers to receive vs. not receive 3 large TachoSil® patches in the dissected axilla. All patients received an axillary drain. Participants and the investigators assessing outcomes were masked to group assignment. The primary endpoint was total volume of axillary drainage.

Results:

Between March 2015 and December 2016, a total of 142 patients were randomized (72 in the TachoSil® group and 70 in the control group). The mean total volume of axillary drainage in the control group was 703 ml (95% confidence interval [CI]: 512 – 895 ml). The application of TachoSil® did not significantly reduce the total volume of axillary drainage (mean difference [MD] -110 ml, 95%CI: -316 – 94, p = 0.30). Similarly, there were no significant differences in the daily volume of drainage and duration until drain removal (MD -2 ml, 95%CI: -10 – 7 ml, p = 0.71 and MD -0.4 days [d], 95%CI: -2.4 – 1.5, p = 0.69, respectively). Hospital stay was longer in the TachoSil® group (MD 1 d, 95%CI: 0.3 – 1.7, p = 0.009). There were no differences regarding seroma, infection or lymphedema at 4 weeks after surgery, and the trend toward a faster decline of pain in the TachoSil® group was not significant (median time to clinically relevant reduction in pain severity 10 d (95%CI: 3 – 27) without and 3 d (95%CI: 1 – 5) with TachoSil®, p = 0.17).

Conclusions:

TachoSil® did not significantly or relevantly reduce drainage after axillary dissection.