Time of Permanence of Dressing Following Breast Reconstruction

Daniela Francescato Veiga

Status: Completed

Conditions: Surgical Site Infection

Treatments: Other: Incisions covered for 1 day; Other: Incisions covered for 6 days

Study type: Interventional

Funder types: Other

Identifiers

NCT01148823

Micro01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Postoperative day 1

Experimental group

Description:

Dressing was removed on the first postoperative day

Treatment:

Other: Incisions covered for 1 day

Postoperative day 6

Experimental group

Description:

Dressing was removed on the 6th postoperative day

Treatment:

Other: Incisions covered for 6 days