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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment
Breast Reconstruction	Other: Cultures taken from the drain discharge

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 Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
Study Start Date :	September 2009

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
control; drains would be removed when daily discharge will be below 20 cc for 2 consecutive days	Other: 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.
study; drains will be removed on post operative day (POD) 10	Other: 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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples Without DNA

cultures of fluids from drain

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients that underwent breast reconstruction with silicone prosthesis and in which drains were left in the surgical field. patients will signed an informed consent form

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Eyal Winkler, MD	972-3-5302416
Contact: Hadar Israeli, MD	972-3-530-2416	Israelihmd@gmail.com

Sponsors and Collaborators

Sheba Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eyal Winkler, MD, Plastic & Reconstructive Department, Sheba Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00973544 History of Changes
Other Study ID Numbers:	SHEBA -08-5530 -EW- CTIL
First Posted:	September 9, 2009
Last Update Posted:	September 9, 2009
Last Verified:	September 2009

Keywords provided by Sheba Medical Center:

breast reconstruction complications; drains; silicone implant