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

• Conditions: Breast Reconstruction
• Interventions: Other: Cultures taken from the drain discharge

• Registration Number: NCT00973544
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Last Update Submitted: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Posted: 2009-09-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control	Cultures taken from the drain discharge	drains would be removed when daily discharge will be below 20 cc for 2 consecutive days
study	Cultures taken from the drain discharge	drains will be removed on post operative day (POD) 10