Surgical Site InfectionNCT01148823
Time of Permanence of Dressing Following Breast Reconstruction
A study testing Incisions covered for 1 day and Incisions covered for 6 days in people with Surgical Site Infection, run by Daniela Francescato Veiga at 1 site in Brazil.
Trial summary
This randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Incisions covered for 1 day and Incisions covered for 6 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2007to Oct 2014
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy
Who cannot join
- use of antibiotics at the time of the operation
- presence of skin lesions on the surgical site
- body mass index over 35Kg/m2
- hard smoking
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí
Pouso Alegre, Minas Gerais, 37550000
About this study
Official title: Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates
This randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization.
Read the detailed description
The rates of surgical site infections (SSI) after clean operations range from 1 to 2%. However, infection rates in the breast surgical literature tend to be higher, with reported rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.
The Centers for Disease Control and Prevention has established guidelines for postoperative incision care. However, there is no recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. This remains an unresolved issue.
- Conditions
- Surgical Site Infection
- Being tested
- Incisions covered for 1 day, Incisions covered for 6 days
- Keywords
- breast, plastic surgery, bandages, surgical site infection, skin colonization
- 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.
Incisions covered for 1 dayOther
Also called PO1
Dressing was removed on the first postoperative day.
Incisions covered for 6 daysOther
Also called PO6
Dressing was removed on the 6th postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative day 1 | Experimental | Dressing was removed on the first postoperative day Receives: Other: Incisions covered for 1 day |
| Postoperative day 6 | Experimental | Dressing was removed on the 6th postoperative day Receives: Other: Incisions covered for 6 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection (SSI)
Patients are followed weekly by a masked surgeon in regard to SSI, until the 30th postoperative day.CDC's criteria and classification was adopted.Patients are reevaluated at the end of the first year after operation.
Measured: 30th postoperative day and one year after operation
Secondary outcomes (2)
Skin colonization
Samples are collected to cultures before dressing (control) and at the 6th postoperative day
Measured: 6 days postoperatively
Patients self assessments
Patients scored dressing wear time with regard to safety, comfort and convenience.
Measured: 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2007
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 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
- Daniela F Veiga, MD, PhD, Study chair, Universidade do Vale do Sapucaí and Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148823
- Sponsor's protocol ID
- Micro01
- Status last verified
- Sep 2019
- First submitted
- 21 Jun 2010
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Veiga DF, Veiga-Filho J, Damasceno CA, Sales EM, Morais TB, Almeida WE, Novo NF, Ferreira LM. Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Feb 22;14:58. doi: 10.1186/1745-6215-14-58.
PubMed 23432779Veiga DF, Veiga-Filho J, Mendes DA, Sales AM, Damasceno Ca, Ferreira LM. Dressing wear time after breast reconstruction: preliminary results of a randomized controlled trial. Plastic and Reconstructive Surgery 131(5S): 119, 2013.
Veiga DF, Damasceno CA, Veiga-Filho J, Paiva LF, Fonseca FE, Cabral IV, Pinto NL, Juliano Y, Ferreira LM. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial. PLoS One. 2016 Dec 2;11(12):e0166356. doi: 10.1371/journal.pone.0166356. eCollection 2016.
PubMed 27911904
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 Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates
- ClinicalTrials.gov ID
- NCT01148823
- Acronym / sponsor ID
- Micro01
- Conditions
- Surgical Site Infection
- Keywords
- breast, plastic surgery, bandages, surgical site infection, skin colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Daniela Francescato VeigaUniversity, hospital or other
- Collaborators
- Universidade do Vale do Sapucai
- Study start
- Jun 2007 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jun 2010 (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 randomized clinical trial was designed to assess the influence of time of dressing after breast reconstruction procedures on surgical site infections rates and skin colonization.
Detailed description
The rates of surgical site infections (SSI) after clean operations range from 1 to 2%. However, infection rates in the breast surgical literature tend to be higher, with reported rates ranging from 2 to 30%. In plastic surgery operations, to minimize the risk of SSI is imperative, since even minor infections are able to complicate the healing process and harm the cosmetic result.
The Centers for Disease Control and Prevention has established guidelines for postoperative incision care. However, there is no recommendation to cover an incision closed primarily beyond 48 hours, nor on the appropriate time to shower or bathe with an uncovered incision. This remains an unresolved issue.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative day 1 | Experimental | Other: Incisions covered for 1 dayDressing was removed on the first postoperative day |
| Postoperative day 6 | Experimental | Other: Incisions covered for 6 daysDressing was removed on the 6th postoperative day |
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)
- •candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy
Key exclusion criteria (4 listed)
- use of antibiotics at the time of the operation
- presence of skin lesions on the surgical site
- body mass index over 35Kg/m2
- 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 |
|---|---|---|
| Incisions covered for 1 dayAlso: PO1Dressing was removed on the first postoperative day. | Other | Postoperative day 1 |
| Incisions covered for 6 daysAlso: PO6Dressing was removed on the 6th postoperative day. | Other | Postoperative day 6 |
Primary outcome
Surgical site infection (SSI)
Time frame: 30th postoperative day and one year after operation
Patients are followed weekly by a masked surgeon in regard to SSI, until the 30th postoperative day.CDC's criteria and classification was adopted.Patients are reevaluated at the end of the first year after operation.
2 secondary outcomes
Skin colonization
Time frame: 6 days postoperatively
Patients self assessments
Time frame: 2 weeks 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 23432779Veiga DF, Veiga-Filho J, Damasceno CA, Sales EM, Morais TB, Almeida WE, Novo NF, Ferreira LM. Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial. Trials. 2013 Feb 22;14:58. doi: 10.1186/1745-6215-14-58.
- Results publicationVeiga DF, Veiga-Filho J, Mendes DA, Sales AM, Damasceno Ca, Ferreira LM. Dressing wear time after breast reconstruction: preliminary results of a randomized controlled trial. Plastic and Reconstructive Surgery 131(5S): 119, 2013.
- Results publication: PubMed 27911904Veiga DF, Damasceno CA, Veiga-Filho J, Paiva LF, Fonseca FE, Cabral IV, Pinto NL, Juliano Y, Ferreira LM. Dressing Wear Time after Breast Reconstruction: A Randomized Clinical Trial. PLoS One. 2016 Dec 2;11(12):e0166356. doi: 10.1371/journal.pone.0166356. eCollection 2016.
- Study ProtocolLink provided by the sponsor.
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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 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 Incisions covered for 1 day and Incisions covered for 6 days 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 1 inclusion and 4 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?
Surgical site infection (SSI) (time frame: 30th postoperative day and one year after operation). 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 NCT01148823, which also lists 3 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.