Back to resultsIncreased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
Primary Purpose
Surgical Side Infections After Breast Reduction
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
250ml HES 6%
9% NaCl 500ml
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Side Infections After Breast Reduction focused on measuring surgical side infection, breast reduction, reduction mammaplasty, prospective trial, microcirculation, breast surgery
Eligibility 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
Sites / Locations
- University of Rostock, Department of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HES group
NaCl group
Arm Description
Application of twice a day 250ml HES 6% for three days postoperatively.
Application twice a day 500ml 9% NaCl for three days postoperatively.
Outcomes
Primary Outcome Measures
Surgical side infection
Primary end point was the development of surgical side infection
Secondary Outcome Measures
Risk factors
Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.
Full Information
NCT ID
NCT01538173
First Posted
February 19, 2012
Last Updated
November 30, 2015
Sponsor
Max Dieterich
Collaborators
University of Rostock
1. Study Identification
Unique Protocol Identification Number
NCT01538173
Brief Title
Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
Official Title
Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Max Dieterich
Collaborators
University of Rostock
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Side Infections After Breast Reduction
Keywords
surgical side infection, breast reduction, reduction mammaplasty, prospective trial, microcirculation, breast surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HES group
Arm Type
Experimental
Arm Description
Application of twice a day 250ml HES 6% for three days postoperatively.
Arm Title
NaCl group
Arm Type
Active Comparator
Arm Description
Application twice a day 500ml 9% NaCl for three days postoperatively.
Intervention Type
Drug
Intervention Name(s)
250ml HES 6%
Intervention Description
Application twice a day 250ml HES 6% for three days postoperatively.
Intervention Type
Drug
Intervention Name(s)
9% NaCl 500ml
Intervention Description
Application twice a day 500ml 9% NaCl for three days postoperatively.
Primary Outcome Measure Information:
Title
Surgical side infection
Description
Primary end point was the development of surgical side infection
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Risk factors
Description
Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Dieterich, MD
Organizational Affiliation
University of Rostock
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rostock, Department of Obstetrics and Gynecology
City
Rostock
State/Province
MV
ZIP/Postal Code
18059
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
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