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

This study has been completed.
Sponsor:
Collaborator:
University of Rostock
Information provided by (Responsible Party):
Max Dieterich, University of Rostock
ClinicalTrials.gov Identifier:
NCT01538173
First received: February 19, 2012
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Surgical Side Infections After Breast Reduction
Drug: 250ml HES 6%
Drug: 9% NaCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • Surgical side infection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Primary end point was the development of surgical side infection


Secondary Outcome Measures:
  • Risk factors [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.


Enrollment: 334
Study Start Date: January 2007
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HES group
Application of twice a day 250ml HES 6% for three days postoperatively.
Drug: 250ml HES 6%
Application twice a day 250ml HES 6% for three days postoperatively.
No Intervention: NaCl group
Application twice a day 500ml 9% NaCl for three days postoperatively.
Drug: 9% NaCl
Application twice a day 500ml 9% NaCl for three days postoperatively.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01538173

Locations
Germany
University of Rostock, Department of Obstetrics and Gynecology
Rostock, MV, Germany, 18059
Sponsors and Collaborators
Max Dieterich
University of Rostock
Investigators
Principal Investigator: Max Dieterich, MD University of Rostock
  More Information

No publications provided

Responsible Party: Max Dieterich, Principle investigator, University of Rostock
ClinicalTrials.gov Identifier: NCT01538173     History of Changes
Other Study ID Numbers: BR02
Study First Received: February 19, 2012
Last Updated: March 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:
surgical side infection
breast reduction
reduction mammaplasty
prospective trial
microcirculation
breast surgery

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014