Time of Permanence of Dressing Following Breast Reconstruction

Surgical Site Infection Clinical Trial

Official title:

Influence of Time of Permanence of Dressing Following Breast Reconstruction on Skin Colonization and on Surgical Site Infection Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148823
• Other study ID #: Micro01
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: October 2014

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

•candidate to immediate or delayed breast reconstruction after mastectomy or segmental mastectomy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Incisions covered for 1 day
Dressing was removed on the first postoperative day.
• Incisions covered for 6 days
Dressing was removed on the 6th postoperative day.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí	Pouso Alegre	MG

Sponsors (2)

Lead Sponsor	Collaborator
Daniela Francescato Veiga	Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

Veiga 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30th postoperative day and one year after operation
Secondary	Skin colonization	Samples are collected to cultures before dressing (control) and at the 6th postoperative day	6 days postoperatively
Secondary	Patients self assessments	Patients scored dressing wear time with regard to safety, comfort and convenience.	2 weeks postoperatively

External Links

•   Study Protocol