Sonographische Verlaufskontrolle nach intraoperativer Anwendung des TissuGlu®-Gewebeklebers bei Mastektomie versus Drainage – eine Beobachtungsstudie

Purpose Postoperative seromas are a problem in the surgical treatment of breast cancer. The aim of the study was to evaluate whether the lysine-urethane-based tissue adhesive TissuGlu® without drainage is equal/ non-inferior to standard mastecomy with drainage. Methods The study was designed as a prospective, randomized, multicentre non-inferiority study comparing the use of TissuGlu® without drainage with standard wound care with a drain insertion in ablative breast procedures. The number of clinical interventions, quality of life and wound complications were followed-up for 90 days in both groups. Results Although the statistical power was not reached, twice as many clinical interventions were performed in the TissuGlu® group than in the drainage group, especially aspirations of clinically relevant seromas (p = 0.014). The TissuGlu® group produced overall less wound fluid, but developed a clinically relevant seroma (100% vs. 63%) which made an intervention necessary. Less hospitalisation time was observed in the TissuGlu® group, but the complication rate was higher. There was no significant difference in regards to postoperative pain. In summary the non-inferiority of TissuGlu® compared to standard drainage couldn’t be reached. Discussion The present evaluation shows no advantage of the tissue adhesive TissuGlu® in terms of seroma formation and frequency of intervention compared to a standard drainage for mastectomies, but the shorter inpatient stay certainly has a positive effect on the quality of life.

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“…showed sonographic tissue changes in the following months, which mostly led to further histological clarifications [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

“…There is evidence that TissuGlu ® leads to long-term sonographic tissue changes: an observational study 43 of 51 patients with intraoperative use of TissuGlu ® showed sonographic tissue changes in the following months, which mostly led to further histological clarifications [22].…”

Section: Discussionmentioning

confidence: 99%