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

Max Dieterich

Status and phase: Completed; Phase 4

Conditions: Surgical Side Infections After Breast Reduction

Treatments: Drug: 250ml HES 6%; Drug: 9% NaCl 500ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01538173

BR02

Details and patient eligibility

About

In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.

Full 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.

Enrollment: 334 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

HES group

Experimental group

Description:

Application of twice a day 250ml HES 6% for three days postoperatively.

Treatment:

Drug: 250ml HES 6%

NaCl group

Active Comparator group

Description:

Application twice a day 500ml 9% NaCl for three days postoperatively.

Treatment:

Drug: 9% NaCl 500ml