Dressing Wear Time After Breast Augmentation With Prosthesis

Surgical Site Infection Clinical Trial

Official title:

Influence of Dressing Wear Time on Skin Colonization After Breast Augmentation With Prosthesis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553604
• Other study ID #: Micro02
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2019
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Months to 60 Years

Eligibility

Inclusion Criteria:

• candidate to breast prosthesis implantation

• body mass index under 30Kg/m2

Exclusion Criteria:

• pregnancy, delivery or breast feeding during the last 12 months

• body mass index over 30Kg/m2

• breast cancer history

• previous breast surgery

• hard smoking

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• augmentation mammaplasty
Dressing is removed on the first postoperative day
• augmentation mammaplasty
Dressing is removed on the 6th postoperative day

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas Samuel Libanio	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Francescato Veiga

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Mendes 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 Ju — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin colonization	skin colonization will be measured through semi-quantitative cultures of samples collected pre-dressing and on 6th postoperative day.	6 days postoperatively
Secondary	surgical site infection	Surgical site infection will be assessed weekly, for 30 days. CDC´s criteria and definitions will be used.	30 days postoperatively