Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?

NCT ID: NCT00973544

Last Updated: 2009-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30

Brief Summary

The purpose of this study is to describe the relations between closed suction drains placement in breast reconstructions procedures with silicone prothesis to the development of local wound complications (seroma, hematoma, infections).

Detailed Description

Breast reconstruction with silicone prosthesis can be divided into two groups: immediate and late reconstructions. The complications rates reported in the literature are around 30% for delayed reconstructions and 50% for immediate reconstructions. The estimated surgical site infection rate is approximately 7% and seroma formation rate is approximately 1.2%.

In many of the procedures closed suction drains are left for fluid drainage, in order to reduce seroma formation. Still, the timing of drains' removal is controversial. Our aim in this study is to describe the relation between the placement of closed suction drains, the timing for their removal, and immediate post operative complications.

Patients that underwent breast reconstruction with silicone prosthesis and in which drains will be left in the surgical field would be randomly assigned into two groups: a control group, in which drains will be removed when the daily discharge will be below 20 cc for two consecutive days and the study group, in which drains will be removed on post operative day (POD) 10. All patients will receive the same antibiotic prophylaxis regimen. Cultures will be taken from fluid discharge POD 4,8,10 and 12. The incidence of local wound complications such as infection, seroma, hematoma and skin necrosis was record and analyzed.

Conditions

Breast Reconstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control

drains would be removed when daily discharge will be below 20 cc for 2 consecutive days

Cultures taken from the drain discharge

Intervention Type: OTHER

Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12. When drain is removed cultures of the drain tip are taken. Clinical signs of surgical signs infections will be observed.

study

drains will be removed on post operative day (POD) 10

Cultures taken from the drain discharge

Intervention Type: OTHER

Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12. When drain is removed cultures of the drain tip are taken. Clinical signs of surgical signs infections will be observed.

Interventions

Cultures taken from the drain discharge

Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12. When drain is removed cultures of the drain tip are taken. Clinical signs of surgical signs infections will be observed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients that underwent immediate or late breast reconstruction with silicone prosthesis (expanders/implants)and in which closed suction drains were left in the operating field according to the decision of the operating surgeon.
• signature of informed consent form

Exclusion Criteria

• age under 18
• breast reconstruction without prosthesis
• Breast reconstruction without the use of drains
• Active infection during time of surgery in surgical site
• Coagulation disease
• Psychiatric illness
• Immune disease
• Lack of communication or language problems
• Foreign residents, not Israeli citizens
• Prisoners

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Plastic & Reconstructive Department, Sheba Medical Center, Israel

Central Contacts

Eyal Winkler, MD

Role: CONTACT

972-3-5302416

Hadar Israeli, MD

Role: CONTACT

Israelihmd@gmail.com

972-3-530-2416

Other Identifiers

SHEBA -08-5530 -EW- CTIL

Identifier Type: -

Identifier Source: org_study_id