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Completed

NCT Number: NCT01538173

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Rostock, Department of Obstetrics and Gynecology

Rostock, Mecklenburg-Vorpommern, 18059, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

250ml HES 6%

Drug

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

9% NaCl 500ml

Drug

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

Primary outcomes

  1. Surgical side infection

    Time frame: 4 weeks

    Primary end point was the development of surgical side infection

Secondary outcomes

  1. Risk factors

    Time frame: 4 weeks

    Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.

Sponsors and collaborators

Lead sponsor

Max Dieterich

Other

Collaborators

  • University of Rostock

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.