Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty

Conditions
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Surgical Side Infections After Breast Reduction

Intervention / Treatment
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* Drug: 250ml HES 6%
* Drug: 9% NaCl 500ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HES group<br>Application of twice a day 250ml HES 6% for three days postoperatively. | Drug: 250ml HES 6%<br>* Application twice a day 250ml HES 6% for three days postoperatively.<br>|
| Active Comparator: NaCl group<br>Application twice a day 500ml 9% NaCl for three days postoperatively. | Drug: 9% NaCl 500ml<br>* Application twice a day 500ml 9% NaCl for three days postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical side infection | Primary end point was the development of surgical side infection | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors | Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical side infection, breast reduction, reduction mammaplasty, prospective trial, microcirculation, breast surgery