68 Chapter 5 mastectomy type (skin-sparing or nipple-sparing), duration of surgery, surgeon/ plastic surgeon, type and size of the implant (TE/definitive prosthesis), initial TE saline fill volume, implant placement technique (submuscular/subglandular), and type of axillary surgery (sentinel node and/or axillary lymph node dissection). This study was conducted in accordance with the Declaration of Helsinki11 and reported according to the Strengthening the Reporting of Observational Studies in Epidemiology statement.12 The local institutional review boards approved the study protocol. Surgical technique In this study, the mastectomy technique used was either nipple-sparing or skinsparing. Antibiotics were administered perioperatively (cefazolin) and (in most cases) postoperatively during hospital stay (Augmentin or flucloxacilline). The implants used were mostly smooth and round (manufactured by Eurosilicone and Mentor). No acellular dermal matrix or mesh was used. The implant placement was pre- or subpectoral. In most of the breasts, drains were used. Clinical course The data on complications were collected retrospectively. Postoperative complications (seroma, hematoma, SSI, wound dehiscence, nipple/skin flap necrosis, and implant loss) were graded according to the Clavien-Dindo classification 13. In grade 1 complications, the normal postoperative course did not deviate, and no interventions were necessary. Grade 2 complications required pharmacological treatment, grade 3 required a radiological or surgical intervention with or without general anesthesia, while grade 4 consisted of life-threatening complications requiring ICU admittance. Seroma was defined as a palpable, unexpected swelling along the operated area without signs of infection (erythema or fever). Hematoma was defined as postoperative hemorrhage or an area of blue/yellow color of the skin and subcutaneous fat. SSI was characterized by erythema, potentially combined with a palpable, unexpected fluctuating swelling along the operated area with or without fever. Wound dehiscence was defined as the widening of the surgical wound. Nipple or skin necrosis was defined as the darkening of the nipple or skin. Implant loss was defined as the need for a second surgery to expand the TE or prosthesis because of the visibility of the implant through the skin, implant infection, or any other reason. Salvage procedures were also scored as implant loss. Other data collected were the timing of drain removal, the reported timing of complication occurrence, and the timing and volume of the first TE saline filling. Statistical analyses IBM SPSS statistics (version 26) was used for standard statistical analysis. Differences in baseline characteristics between the groups were tested with the
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