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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00973544
• Other study ID #: SHEBA -08-5530 -EW- CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 8, 2009
• Last updated: September 8, 2009
• Start date: September 2009

Study information

• Verified date: September 2009
• Source: Sheba Medical Center
• Contact: Eyal Winkler, MD
• Phone: 972-3-5302416
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center