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

NCT ID: NCT01538173

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Surgical Side Infections After Breast Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HES group

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

Group Type EXPERIMENTAL

250ml HES 6%

Intervention Type DRUG

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

NaCl group

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

Group Type ACTIVE_COMPARATOR

9% NaCl 500ml

Intervention Type DRUG

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

Interventions

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250ml HES 6%

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

Intervention Type DRUG

9% NaCl 500ml

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Rostock

OTHER

Sponsor Role collaborator

Max Dieterich

OTHER

Sponsor Role lead

Responsible Party

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Max Dieterich

Principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Max Dieterich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rostock

Locations

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University of Rostock, Department of Obstetrics and Gynecology

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

Other Identifiers

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BR02

Identifier Type: -

Identifier Source: org_study_id