Surgical Site InfectionNCT01553604
Dressing Wear Time After Breast Augmentation With Prosthesis
A study testing augmentation mammaplasty in people with Surgical Site Infection, 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 augmentation mammaplasty influence skin colonization and eventually surgical site infections rates. Read more about this study
- Who is it for?
- Ages 18 months to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- augmentation mammaplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Sep 2015
- 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 months to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- candidate to breast prosthesis implantation
- 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 Libanio
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
Read the detailed description
Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.
The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.
CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.
- Conditions
- Surgical Site Infection
- Being tested
- augmentation mammaplasty
- Keywords
- breast prosthesis implantation, bandages, skin colonization, surgical site infection, augmentation mammaplasty, dressing wear time
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmentation mammaplastyProcedure or surgery
Dressing is removed on the first postoperative day
augmentation mammaplastyProcedure or surgery
Dressing is removed on the 6th postoperative day
| Study group | Role | What they receive |
|---|---|---|
| Postoperative day 6 | Experimental | Dressing is removed on the sixth postoperative day Receives: Procedure: augmentation mammaplasty |
| Postoperative day 1 | Experimental | Dressing is removed on the first postoperative day Receives: Procedure: augmentation mammaplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin colonization
skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.
Measured: 6 days postoperatively
Secondary outcomes (1)
surgical site infection
Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Francescato Veiga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Francescato Veiga, Federal University of São Paulo
- Investigators
- Daniela F Veiga, MD, PhD, Study director, Universidade Federal de São PauloJoel Veiga-Filho, MD, PhD, Principal investigator, Universidade do Vale do SapucaíLydia M Ferreira, MD, PhD, Study chair, Universidade Federal de São PauloDenise A Mendes, MD, PhD, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553604
- Sponsor's protocol ID
- Micro02
- Status last verified
- Sep 2019
- First submitted
- 12 Mar 2012
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendes Dde A, Veiga DF, Veiga-Filho J, Fonseca FE, de Paiva LF, Novo NF, Loyola AB, Ferreira LM. Application time for postoperative wound dressing following breast augmentation with implants: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:19. doi: 10.1186/s13063-014-0529-5.
PubMed 25623237Mendes DA, Veiga DF, Veiga-Filho J, Loyola ABAT, Paiva LF, Novo NF, Sabino-Neto M, Ferreira LM. Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):906-912. doi: 10.1016/j.bjps.2018.01.021. Epub 2018 Feb 21.
PubMed 29475792
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01553604
- Acronym / sponsor ID
- Micro02
- Conditions
- Surgical Site Infection
- Keywords
- breast prosthesis implantation, bandages, skin colonization, surgical site infection, augmentation mammaplasty, dressing wear time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Daniela Francescato VeigaUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Mar 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.
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
Detailed description
Augmentation mammaplasty is currently one of the most performed plastic surgery procedures. It is a clean operation, and surgical site infection (SSI) rates are low. However, a SSI, since a minor one, leads to the failure of the procedure. Thus, minimizing SSI risks is imperative.
The Centers for Disease Control and Prevention (CDC) provides recommendations concerning prevention of SSI.No recommendation is offered for some practices, either because there is a lack of consensus regarding their efficacy or because of the available scientific evidence is insufficient to support their adoption.
CDC´s "Guideline for Prevention of Surgical Site Infection" recommends protecting with a sterile dressing for 24 to 48 hours an incision that has been closed primarily. There is no recommendation to cover the incision beyond 48 hours. One major risk factor for SSI is the presence of bacteria at surgical site.Thus, this trial was designed to verify the influence of dressing wear time on skin colonization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative day 6 | Experimental | Procedure: augmentation mammaplastyDressing is removed on the sixth postoperative day |
| Postoperative day 1 | Experimental | Procedure: augmentation mammaplastyDressing is removed on the first postoperative day |
Who may qualify
- Ages
- 18 months to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- candidate to breast prosthesis implantation
- 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 |
|---|---|---|
| augmentation mammaplastyDressing is removed on the first postoperative day | Procedure or surgery | Postoperative day 1 |
| augmentation mammaplastyDressing is removed on the 6th postoperative day | Procedure or surgery | Postoperative day 6 |
Primary outcome
skin colonization
Time frame: 6 days postoperatively
skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.
1 secondary outcome
surgical site infection
Time frame: 30 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 6 Sep 2019.
- Background: PubMed 25623237Mendes Dde A, Veiga DF, Veiga-Filho J, Fonseca FE, de Paiva LF, Novo NF, Loyola AB, Ferreira LM. Application time for postoperative wound dressing following breast augmentation with implants: study protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:19. doi: 10.1186/s13063-014-0529-5.
- Results publication: PubMed 29475792Mendes DA, Veiga DF, Veiga-Filho J, Loyola ABAT, Paiva LF, Novo NF, Sabino-Neto M, Ferreira LM. Influence of dressing application time after breast augmentation on cutaneous colonization: A randomized clinical trial. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):906-912. doi: 10.1016/j.bjps.2018.01.021. Epub 2018 Feb 21.
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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.
Daniela F Veiga, MD, PhD study director
Universidade Federal de São Paulo
Joel Veiga-Filho, MD, PhD principal investigator
Universidade do Vale do Sapucaí
Lydia M Ferreira, MD, PhD study chair
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 augmentation mammaplasty in people with Surgical Site Infection, 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 2 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 6 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?
skin colonization (time frame: 6 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 NCT01553604, which also lists 2 linked publications.
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 6 Sep 2019.