Chapter 6 technique. In addition, the patient population that undergoes this procedure is relatively homogenous, and the flap characteristics are constant. Patients and methods A randomized, double‐blind, placebo‐controlled clinical trial was performed that included 20 patients. The Ethics Committee of Maastricht University Medical Center approved the study protocol, and written informed consent was obtained from each subject. Patients were assigned randomly to arginine (n=10) or placebo treatment (n=10), by an independent clinical pharmacist, using numbered envelopes. Patients included had a free TRAM flap for secondary breast reconstruction after mastectomy resulting from breast cancer. With this procedure, the lower abdominal fat and skin based on the deep inferior epigastric artery is transplanted and an anastomosis is made to the internal mammary artery to reconstruct the breast. The muscle‐sparing procedure was chosen to reduce donor‐site morbidity. After complete dissection, the flap is divided into four perfusion zones as reported previously.20 Zone I is the central zone in the flap with the best perfusion, whereas zone IV is the most distal part with less collateral circulation and is usually the area at risk for insufficient perfusion and subsequent flap loss. This free flap was chosen because it is a frequently performed and standardized procedure, which ensured homogeneity between the participants. Patients were not admitted to the study if there was a history of previous midline laparotomy, which alters the lower abdominal circulation. Because the use of the total flap for reconstruction was considered relatively safe, zone IV was largely included in the reconstructed breast during the study.21 Patient medical history and demographics were recorded (Table 6.1). In addition, flap data such as total flap weight and weight used for breast reconstruction, percentage skin necrosis, and a disturbed wound healing in the outpatient clinic were recorded meticulously. Table 6.1 Definition and abbreviations used for Flap complications. Complication Abbreviation Definition Clinical impact Minor partial flap loss Minor PFL Loss of a cutaneous portion of Treated conservatively without the flap with or without fat adverse outcome. If necessary necrosis. Skin necrosis is less scars will be addressed during then 5% of the skin surface used standard second stage revision. in the reconstructed breast. Major partial flap loss Major PFL Same as minor PFL but with >5% Return to theatre for loss of skin surface. debridement. Minor effect on aesthetic outcome. 88
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