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

NCT00973544 | Unknown

• 1 other identifier: SHEBA -08-5530 -EW- CTIL
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Breast Reconstruction

Keywords

breast reconstruction complications; drains; silicone implant

Study Arms (2)

control

drains would be removed when daily discharge will be below 20 cc for 2 consecutive days

Other: Cultures taken from the drain discharge

study

drains will be removed on post operative day (POD) 10

Other: Cultures taken from the drain discharge

Interventions

Cultures taken from the drain discharge OTHER

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.

control; study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

cultures of fluids from drain

Central Study Contacts

Eyal Winkler, MD

CONTACT

972-3-5302416

Hadar Israeli, MD

CONTACT

972-3-530-2416; Israelihmd@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Last Updated: September 9, 2009

Record last verified: 2009-09