University of Rostock, Department of Obstetrics and Gynecology
Rostock, Mecklenburg-Vorpommern, 18059, Germany
NCT Number: NCT01538173
In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.
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Notify Me18 year–70 year
Female
Interventional
Phase 4
Rostock, Mecklenburg-Vorpommern, 18059, Germany
Many studies identifying risk factors for surgical side infections (SSI) after breast surgery included a large percentage of breast conserving therapies and risk factors for patients undergoing more extensive procedures like breast reduction (BR) are underrepresented and risk factors for more extensive breast surgeries might not be identified. Our approach to decrease SSI after BR was the application of an i.v. isotonic crystalloid solution, 6% hydroxyethylstaerke (HES) as a diminished peripheral blood flow and impaired vasculogenesis are characteristics of poorly healing wounds. HES causes a medium- to long-term increase in blood volume, blood flow and improved blood oxygen transport. Blood flow and tissue oxygenation are parts of regulating the healing process by utilizing molecular oxygen as a terminal oxidant. This antioxidant capacity can influence the wound healing process positively, as a characteristic feature of the inflammatory phase is the oxidative burst. HES additionally decreases haematocrite, blood viscosity and aggregation of erythrocytes positively influencing the complex components regulating wound healing. These characteristics and the increase in blood circulation might influence the postoperative healing and regeneration process.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application twice a day 250ml HES 6% for three days postoperatively.
Application twice a day 500ml 9% NaCl for three days postoperatively.
Time frame: 4 weeks
Primary end point was the development of surgical side infection
Time frame: 4 weeks
Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.
Max Dieterich
Other
Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
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