NCT00356148

Brief Summary

This is a single center trial to compare the rate of surgical site infection (SSI) in normal (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are undergoing breast cancer surgery. The overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam; Prophylaxis Group), in the other they do not (No Prophylaxis Group).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 30, 2013

Completed
Last Updated

January 30, 2013

Status Verified

December 1, 2012

Enrollment Period

6.4 years

First QC Date

July 24, 2006

Results QC Date

April 20, 2012

Last Update Submit

December 19, 2012

Conditions

Breast Cancer

Keywords

breast cancerbreast surgeryclean woundoverweightprophylaxisantibiotics

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).

    1 month

Secondary Outcomes (1)

  • Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).

    1 month

Study Arms (2)

Prophylaxis Group

ACTIVE COMPARATOR

patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis

Drug: Ampicillin/Sulbactam

No Prophylaxis Group

NO INTERVENTION

Patients who are BMI over 25 and do not receive antibiotic prophylaxis

Interventions

Ampicillin/SulbactamDRUG

Ampicillin/Sulbactam 1 gr, once within onr hour before surgery

Also known as: Ampisid 1 gr
Prophylaxis Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.

You may not qualify if:

  • Ductal carcinoma in situ (DCIS; stage 0 cancer),
  • Advanced or distant metastatic stage,
  • Receiving any neoadjuvant therapy,
  • History of receiving any antibiotics within prior 3 months,
  • History of immunodeficiency,
  • Having a remote infection,
  • History of reaction to study antibiotics,
  • Denial of signing the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Hospital

Istanbul, 34662, Turkey (Türkiye)

Location

Related Publications (2)

  • Cunningham M, Bunn F, Handscomb K. Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005360. doi: 10.1002/14651858.CD005360.pub2.

    PMID: 16625637BACKGROUND

  • Gulluoglu BM, Guler SA, Ugurlu MU, Culha G. Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial. Ann Surg. 2013 Jan;257(1):37-43. doi: 10.1097/SLA.0b013e31826d832d.

    PMID: 23001082DERIVED

MeSH Terms

Conditions

Breast NeoplasmsOverweight

Interventions

sultamicillin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Bahadir M Gulluoglu
Organization
Marmara University School of Medicine
bmgulluoglu@marmara.edu.tr
902164256565

Study Officials

  • Bahadir M Gulluoglu, MD, FACS

    Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Bahadir M Gulluoglu, MD, FACS

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

October 1, 2003

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

January 30, 2013

Results First Posted

January 30, 2013

Record last verified: 2012-12

Locations

TU(1)