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

Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00973544
Enrollment
100
Registered
2009-09-09
Start date
2009-09-30
Completion date
Unknown
Last updated
2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction

Keywords

breast reconstruction complications, drains, silicone implant

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.

Interventions

OTHERCultures 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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Primary ContactEyal Winkler, MD
972-3-5302416
Backup ContactHadar Israeli, MD
Israelihmd@gmail.com972-3-530-2416

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026