Surgical Site InfectionNCT01002391
Dressing Wear Time After Reduction Mammaplasty
A study testing reduction mammaplasty in people with Surgical Site Infection and Skin Colonization, run by Daniela Francescato Veiga at 1 site in Brazil.
Trial summary
This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Surgical Site Infection, Skin Colonization
- What is being tested?
- reduction mammaplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Sep 2010
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- breast hypertrophy
- candidate to reduction mammaplasty
- body mass index under 30Kg/m2
Who cannot join
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- hard smoking
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas Samuel Libânio - UNIVÁS
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty
This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.
Read the detailed description
Surgical site infections (SSI) are wound infections that occur after invasive procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.
Reduction mammaplasty is an effective and well established procedure performed for the relief of physical pain and discomfort associated with macromastia, which significantly decreases patients' quality of life.Breast reduction has provided long-term relief for most patients, with high patient satisfaction.
The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most commonly surgical procedure performed by plastic surgeons in women of United States.Since reduction mammaplasty is associated with a high incidence of wound problems,all effort to minimize the risk of SSI is valid.
- Conditions
- Surgical Site Infection, Skin Colonization
- Being tested
- reduction mammaplasty
- Keywords
- breast hypertrophy, mammaplasty, bandages, surgical site infection, skin colonization
- Medical subject headings
- Surgical Wound Infection, Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction mammaplastyProcedure or surgery
Also called Breast reduction surgery
Dressing following reduction mammaplasty is removed on the first postoperative day
reduction mammaplastyProcedure or surgery
Also called Breast reduction surgery
Dressing following reduction mammaplasty is removed on the sixth postoperative day
| Study group | Role | What they receive |
|---|---|---|
| Postoperative day 1 | Experimental | Dressing is removed on the first postoperative day Receives: Procedure: reduction mammaplasty |
| Postoperative day 6 | Experimental | Dressing is removed on the sixth postoperative day Receives: Procedure: reduction mammaplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
Measured: 30 days postoperatively
Secondary outcomes (1)
skin colonization
Measured: 6 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Francescato Veiga
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Responsible party
- Sponsor-investigator, Daniela Francescato Veiga, Federal University of São Paulo
- Investigators
- Joel Veiga-Filho, MD, MSc, Principal investigator, Universidade do Vale do Sapucaí and Universidade Federal de São PauloDaniela F Veiga, MD, PhD, Study director, Universidade do Vale do Sapucaí and Universidade Federal de São PauloLydia M Ferreira, MD, PhD, Study chair, Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002391
- Sponsor's protocol ID
- dinter01
- Status last verified
- Sep 2019
- First submitted
- 23 Oct 2009
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CAV, Sales EML, Garcia ES, Oliveira IB, De Simoni LF, Juliano Y, Ferreira LM. Dressing wear time after reduction mammaplasty: a randomized controlled trial. Plast Reconstr Surg. 2012 Jan;129(1):1e-7e. doi: 10.1097/PRS.0b013e3182361ee9.
PubMed 22186564
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twenty-four Hours or 6 Days? A Prospective Randomized Trial Comparing Dressing Wear Time After Reduction Mammaplasty
- ClinicalTrials.gov ID
- NCT01002391
- Acronym / sponsor ID
- dinter01
- Conditions
- Surgical Site Infection, Skin Colonization
- Keywords
- breast hypertrophy, mammaplasty, bandages, surgical site infection, skin colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Daniela Francescato VeigaUniversity, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Oct 2009 (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.
This study was designed to determine whether the duration of dressing wear following reduction mammaplasty influence skin colonization and surgical site infections rates.
Detailed description
Surgical site infections (SSI) are wound infections that occur after invasive procedures.Particularly in plastic surgery procedures, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.
Reduction mammaplasty is an effective and well established procedure performed for the relief of physical pain and discomfort associated with macromastia, which significantly decreases patients' quality of life.Breast reduction has provided long-term relief for most patients, with high patient satisfaction.
The demand for this kind of plastic surgery is high.Reduction mammaplasty was the fifth most commonly surgical procedure performed by plastic surgeons in women of United States.Since reduction mammaplasty is associated with a high incidence of wound problems,all effort to minimize the risk of SSI is valid.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative day 1 | Experimental | Procedure: reduction mammaplastyDressing is removed on the first postoperative day |
| Postoperative day 6 | Experimental | Procedure: reduction mammaplastyDressing is removed on the sixth postoperative day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- breast hypertrophy
- candidate to reduction mammaplasty
- body mass index under 30Kg/m2
Key exclusion criteria (5 listed)
- pregnancy, delivery or breast feeding during the last 12 months
- body mass index over 30Kg/m2
- breast cancer history
- previous breast surgery
- hard smoking
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 |
|---|---|---|
| reduction mammaplastyAlso: Breast reduction surgeryDressing following reduction mammaplasty is removed on the first postoperative day | Procedure or surgery | Postoperative day 1 |
| reduction mammaplastyAlso: Breast reduction surgeryDressing following reduction mammaplasty is removed on the sixth postoperative day | Procedure or surgery | Postoperative day 6 |
Primary outcome
surgical site infection
Time frame: 30 days postoperatively
1 secondary outcome
skin colonization
Time frame: 6 days postoperatively
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 4 Sep 2019.
- Results publication: PubMed 22186564Veiga-Filho J, Veiga DF, Sabino-Neto M, Damasceno CAV, Sales EML, Garcia ES, Oliveira IB, De Simoni LF, Juliano Y, Ferreira LM. Dressing wear time after reduction mammaplasty: a randomized controlled trial. Plast Reconstr Surg. 2012 Jan;129(1):1e-7e. doi: 10.1097/PRS.0b013e3182361ee9.
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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.
Joel Veiga-Filho, MD, MSc principal investigator
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Daniela F Veiga, MD, PhD study director
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
Lydia M Ferreira, MD, PhD study chair
Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reduction mammaplasty in people with Surgical Site Infection and Skin Colonization, run by Daniela Francescato Veiga at 1 site in Brazil.
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 3 inclusion and 5 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 4 Sep 2019. 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 Brazil. 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.
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 site infection (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002391, which also lists 1 linked publication.
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 4 Sep 2019.