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

Surgical Side Infections After Breast Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538173
• Other study ID #: BR02
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2012
• Last updated: November 30, 2015
• Start date: January 2007
• Est. completion date: February 2012

Study information

• Verified date: November 2015
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: February 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Side Infections After Breast Reduction
• Surgical Wound Infection

Intervention

Drug:
• 250ml HES 6%
Application twice a day 250ml HES 6% for three days postoperatively.
• 9% NaCl 500ml
Application twice a day 500ml 9% NaCl for three days postoperatively.

Locations

Country	Name	City	State
Germany	University of Rostock, Department of Obstetrics and Gynecology	Rostock	MV

Sponsors (2)

Lead Sponsor	Collaborator
Max Dieterich	University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical side infection	Primary end point was the development of surgical side infection	4 weeks	No
Secondary	Risk factors	Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.	4 weeks	No