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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
Sponsor:
Information provided by:
Sheba Medical Center

Study Description
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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

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Groups and Cohorts
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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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Biospecimen Retention:   Samples Without DNA
cultures of fluids from drain

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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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


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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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