A Phase 4 interventional study of 250ml HES 6% and 9% NaCl 500ml in Surgical Side Infections After Breast Reduction, sponsored by Max Dieterich. Completed at 1 site in Germany. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Max Dieterich · Phase 4, Interventional, and Prevention
In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 334 is above the median of 120 across 4,201 interventional studies indexed under Infections.
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Exclusion Criteria:
Application of twice a day 250ml HES 6% for three days postoperatively.
Drug: 250ml HES 6%
Application twice a day 500ml 9% NaCl for three days postoperatively.
Drug: 9% NaCl 500ml
Application twice a day 250ml HES 6% for three days postoperatively.
Application twice a day 500ml 9% NaCl for three days postoperatively.
Surgical side infection
Primary end point was the development of surgical side infection
Time frame: 4 weeks
Risk factors
Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.
Time frame: 4 weeks
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Max Dieterich