Do Closed Suction Drains Affect the Complications Rate of... | NCT00973544

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

NCT00973544

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Sep 9, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Breast Reconstruction

Interventions

Cultures taken from the drain discharge

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2009

Last Update Posted Date

Sep 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eyal Winkler, MD	Contact	972-3-5302416
Hadar Israeli, MD	Contact	972-3-530-2416		Israelihmd@gmail.com

Overall Officials

Not provided

Locations

Not provided