Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
Recruitment status was Not yet recruiting
|First Received Date ICMJE||September 8, 2009|
|Last Updated Date||September 8, 2009|
|Start Date ICMJE||September 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?|
|Official Title ICMJE||Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains|
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).
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 Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
cultures of fluids from drain
|Sampling Method||Probability Sample|
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
|Condition ICMJE||Breast Reconstruction|
|Intervention ICMJE||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 Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||100|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00973544|
|Other Study ID Numbers ICMJE||SHEBA -08-5530 -EW- CTIL|
|Has Data Monitoring Committee||No|
|Responsible Party||Eyal Winkler, MD, Plastic & Reconstructive Department, Sheba Medical Center, Israel|
|Study Sponsor ICMJE||Sheba Medical Center|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Sheba Medical Center|
|Verification Date||September 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP