Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
Overview
- Phase
- Phase 4
- Intervention
- 250ml HES 6%
- Conditions
- Surgical Side Infections After Breast Reduction
- Sponsor
- Max Dieterich
- Enrollment
- 334
- Locations
- 1
- Primary Endpoint
- Surgical side infection
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.
Detailed Description
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.
Investigators
Max Dieterich
Principle investigator
University of Rostock
Eligibility Criteria
Inclusion Criteria
- •Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.
Exclusion Criteria
- •Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery
Arms & Interventions
HES group
Application of twice a day 250ml HES 6% for three days postoperatively.
Intervention: 250ml HES 6%
NaCl group
Application twice a day 500ml 9% NaCl for three days postoperatively.
Intervention: 9% NaCl 500ml
Outcomes
Primary Outcomes
Surgical side infection
Time Frame: 4 weeks
Primary end point was the development of surgical side infection
Secondary Outcomes
- Risk factors(4 weeks)