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

Phase 4

Completed

• Conditions: Surgical Side Infections After Breast Reduction
• Interventions: Drug: 250ml HES 6%; Drug: 9% NaCl 500ml

• Registration Number: NCT01538173
• Lead Sponsor: Max Dieterich

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2011-10
• Study Completion: 2012-02
• Study First Submitted: 2012-02-19
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-23
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HES group	250ml HES 6%	Application of twice a day 250ml HES 6% for three days postoperatively.
NaCl group	9% NaCl 500ml	Application twice a day 500ml 9% NaCl for three days postoperatively.

Primary Outcome Measures

Name	Time	Method
Surgical side infection	4 weeks	Primary end point was the development of surgical side infection

Secondary Outcome Measures

Name	Time	Method
Risk factors	4 weeks	Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.

Trial Locations

Locations (1)

University of Rostock, Department of Obstetrics and Gynecology; 🇩🇪 Rostock, MV, Germany