Surgical Side Infections After Breast ReductionPhase 4NCT01538173
Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
A Phase 4 study testing 250ml HES 6% and 9% NaCl 500ml in people with Surgical Side Infections After Breast Reduction, run by Max Dieterich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Surgical Side Infections After Breast Reduction
- What is being tested?
- 250ml HES 6% and 9% NaCl 500ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.
Who cannot join
- Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Rostock, Department of Obstetrics and Gynecology
Rostock, Mecklenburg-Vorpommern, 18059
About this study
Official title: Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.
Read the 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.
- Being tested
- 250ml HES 6%, 9% NaCl 500ml
- Keywords
- surgical side infection, breast reduction, reduction mammaplasty, prospective trial, microcirculation, breast surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250ml HES 6%Drug
Application twice a day 250ml HES 6% for three days postoperatively.
9% NaCl 500mlDrug
Application twice a day 500ml 9% NaCl for three days postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| HES group | Experimental | Application of twice a day 250ml HES 6% for three days postoperatively. Receives: Drug: 250ml HES 6% |
| NaCl group | Active comparator | Application twice a day 500ml 9% NaCl for three days postoperatively. Receives: Drug: 9% NaCl 500ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical side infection
Primary end point was the development of surgical side infection
Measured: 4 weeks
Secondary outcomes (1)
Risk factors
Secondary endpoints were identification of possible risk factors for surgical side infections and nipple necrosis after breast reduction.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJan 2007
- Primary completionOct 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Side Infections After Breast ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Dieterich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rostock
- Responsible party
- Sponsor-investigator, Max Dieterich, University of Rostock
- Investigators
- Max Dieterich, MD, Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538173
- Sponsor's protocol ID
- BR02
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Investigating the Role of Increased Microcirculation for Preventing Postoperative Surgical Side Infections in Patients Undergoing Reduction Mammoplasty
- ClinicalTrials.gov ID
- NCT01538173
- Acronym / sponsor ID
- BR02
- Keywords
- surgical side infection, breast reduction, reduction mammaplasty, prospective trial, microcirculation, breast surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Max DieterichUniversity, hospital or other
- Collaborators
- University of Rostock
- Study start
- Jan 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HES group | Experimental | Drug: 250ml HES 6%Application of twice a day 250ml HES 6% for three days postoperatively. |
| NaCl group | Active comparator | Drug: 9% NaCl 500mlApplication twice a day 500ml 9% NaCl for three days postoperatively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.
Key exclusion criteria (1 listed)
- Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 250ml HES 6%Application twice a day 250ml HES 6% for three days postoperatively. | Drug | HES group |
| 9% NaCl 500mlApplication twice a day 500ml 9% NaCl for three days postoperatively. | Drug | NaCl group |
Primary outcome
Surgical side infection
Time frame: 4 weeks
Primary end point was the development of surgical side infection
1 secondary outcome
Risk factors
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Dieterich, MD principal investigator
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 250ml HES 6% and 9% NaCl 500ml in people with Surgical Side Infections After Breast Reduction, run by Max Dieterich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical side infection (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.