Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
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ClinicalTrials.gov Identifier: NCT00973544 |
Recruitment Status
: Unknown
Verified September 2009 by Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted
: September 9, 2009
Last Update Posted
: September 9, 2009
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Condition or disease | Intervention/treatment |
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Breast Reconstruction | Other: Cultures taken from the drain discharge |
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 : | 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 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973544
Contact: Eyal Winkler, MD | 972-3-5302416 | ||
Contact: Hadar Israeli, MD | 972-3-530-2416 | Israelihmd@gmail.com |
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 Key Record Dates |
Last Update Posted: | September 9, 2009 |
Last Verified: | September 2009 |
Keywords provided by Sheba Medical Center:
breast reconstruction complications drains silicone implant |