NCT01538173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

4.8 years

First QC Date

February 19, 2012

Last Update Submit

November 30, 2015

Conditions

Surgical Side Infections After Breast Reduction

Keywords

surgical side infectionbreast reductionreduction mammaplastyprospective trialmicrocirculationbreast surgery

Outcome Measures

Primary Outcomes (1)

  • Surgical side infection

    Primary end point was the development of surgical side infection

    4 weeks

Secondary Outcomes (1)

  • Risk factors

    4 weeks

Study Arms (2)

HES group

EXPERIMENTAL

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

Drug: 250ml HES 6%

NaCl group

ACTIVE COMPARATOR

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

Drug: 9% NaCl 500ml

Interventions

250ml HES 6%DRUG

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

HES group
9% NaCl 500mlDRUG

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

NaCl group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.

You may not qualify if:

  • Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock, Department of Obstetrics and Gynecology

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

Study Officials

  • Max Dieterich, MD

    University of Rostock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 19, 2012

First Posted

February 23, 2012

Study Start

January 1, 2007

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

DE(1)