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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01538173
Enrollment
334
Registered
2012-02-23
Start date
2007-01-31
Completion date
2012-02-29
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Side Infections After Breast Reduction

Keywords

surgical side infection, breast reduction, reduction mammaplasty, prospective trial, microcirculation, breast surgery

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.

Interventions

DRUG250ml HES 6%

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

DRUG9% NaCl 500ml

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

Sponsors

University of Rostock
CollaboratorOTHER
Max Dieterich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical side infection4 weeksPrimary end point was the development of surgical side infection

Secondary

MeasureTime frameDescription
Risk factors4 weeksSecondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026