Breast ReconstructionNCT00973544
Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
An observational study of Breast Reconstruction, run by Sheba Medical Center.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Cultures taken from the drain discharge
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Immune disease
- Lack of communication or language problems
- Foreign residents, not Israeli citizens
- Prisoners
Trial locations and contacts
No sites are listed yet.
Eyal Winkler, MD contact
About this study
Official title: Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
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).
Read the 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.
- Conditions
- Breast Reconstruction
- Being tested
- Cultures taken from the drain discharge
- Keywords
- breast reconstruction complications, drains, silicone implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultures taken from the drain dischargeOther
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 group | Role | What they receive |
|---|---|---|
| control | drains would be removed when daily discharge will be below 20 cc for 2 consecutive days Receives: Other: Cultures taken from the drain discharge | |
| study | drains will be removed on post operative day (POD) 10 Receives: Other: Cultures taken from the drain discharge |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973544
- Sponsor's protocol ID
- SHEBA -08-5530 -EW- CTIL
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
- ClinicalTrials.gov ID
- NCT00973544
- Acronym / sponsor ID
- SHEBA -08-5530 -EW- CTIL
- Conditions
- Breast Reconstruction
- Keywords
- breast reconstruction complications, drains, silicone implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2009
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: Cultures taken from the drain dischargedrains would be removed when daily discharge will be below 20 cc for 2 consecutive days |
| study | – | Other: Cultures taken from the drain dischargedrains will be removed on post operative day (POD) 10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultures taken from the drain dischargeCultures 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. | Other | control, study |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Winkler, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyal Winkler, MD (972-3-5302416), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2009.