Time of Permanence of Dressing Following Breast Reconstruction

NCT01148823 | Completed

• 1 other identifier: Micro01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

breast; plastic surgery; bandages; surgical site infection; skin colonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin colonization

  6 days postoperatively

• Patients self assessments

  2 weeks postoperatively

Study Arms (2)

Postoperative day 1

EXPERIMENTAL

Dressing was removed on the first postoperative day

Other: Incisions covered for 1 day

Postoperative day 6

EXPERIMENTAL

Dressing was removed on the 6th postoperative day

Other: Incisions covered for 6 days

Interventions

Incisions covered for 1 day OTHER

Dressing was removed on the first postoperative day.

Also known as: PO1

Postoperative day 1

Incisions covered for 6 days OTHER

Dressing was removed on the 6th postoperative day.

Also known as: PO6

Postoperative day 6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniela Francescato Veiga: lead
• Universidade do Vale do Sapucai: collaborator

Study Sites (1)

Hospital das Clinicas Samuel Libânio, Universidade do Vale do Sapucaí

Pouso Alegre, Minas Gerais, 37550000, Brazil

Location

Related Publications (3)

• 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.

  PMID: 23432779 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 27911904 RESULT

Related Links

• Study Protocol

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniela F Veiga, MD, PhD

  Universidade do Vale do Sapucaí and Universidade Federal de São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2007
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

BR (1)