Time of Permanence of Dressing Following Breast Reconstruction

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Other: Incisions covered for 6 days; Other: Incisions covered for 1 day

• Registration Number: NCT01148823
• Lead Sponsor: Daniela Francescato Veiga

Brief 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.

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative day 6	Incisions covered for 6 days	Dressing was removed on the 6th postoperative day
Postoperative day 1	Incisions covered for 1 day	Dressing was removed on the first postoperative day

Primary Outcome Measures

Name	Time	Method
Surgical site infection (SSI)	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.

Secondary Outcome Measures

Name	Time	Method
Skin colonization	6 days postoperatively	Samples are collected to cultures before dressing (control) and at the 6th postoperative day
Patients self assessments	2 weeks postoperatively	Patients scored dressing wear time with regard to safety, comfort and convenience.

Trial Locations

Locations (1)

Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí; 🇧🇷 Pouso Alegre, MG, Brazil