Trial Outcomes & Findings for The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients. (NCT NCT00356148)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

372 participants

Primary outcome timeframe

1 month

Results posted on

2013-01-30

Participant Flow

Patients were recruited at a tertiary university teaching hospital between October 2003 and March 2010.

Patients having male gender, diagnosis of Stage 0, locally advanced or bilateral breast cancer, receiving neoadjuvant treatment, planning to undergo reconstructive surgery, having immunodeficiency, receiving antibiotics during previous one month, undergoing breast / axilla operation before randomization, denying to provide consent were excluded.

Participant milestones

Participant milestones
Measure	Prophylaxis Group patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis	No Prophylaxis Group Patients who are BMI over 25 and do not receive antibiotic prophylaxis
Overall Study STARTED	189	183
Overall Study COMPLETED	187	182
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Prophylaxis Group patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis	No Prophylaxis Group Patients who are BMI over 25 and do not receive antibiotic prophylaxis
Overall Study Reoperation within 30 days	2	1

Baseline Characteristics

The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prophylaxis Group n=189 Participants patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis	No Prophylaxis Group n=183 Participants Patients who are BMI over 25 and do not receive antibiotic prophylaxis	Total n=372 Participants Total of all reporting groups
Age Continuous	59.1 years STANDARD_DEVIATION 11.1 • n=5 Participants	56.9 years STANDARD_DEVIATION 14.1 • n=7 Participants	57.5 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	189 Participants n=5 Participants	183 Participants n=7 Participants	372 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Analysis was intent-to-treat

Outcome measures

Outcome measures
Measure	Prophylaxis Group n=187 Participants patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis	No Prophylaxis Group n=182 Participants Patients who are BMI over 25 and not receive antibiotic prophylaxis
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).	9 participants	25 participants

SECONDARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	Prophylaxis Group n=187 Participants patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis	No Prophylaxis Group n=182 Participants Patients who are BMI over 25 and not receive antibiotic prophylaxis
Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).	30 Monetary unit in Turkish Liras Standard Error 5.6	13 Monetary unit in Turkish Liras Standard Error 3.2

Adverse Events

Prophylaxis Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Prophylaxis Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Bahadir M Gulluoglu

Marmara University School of Medicine

Phone: 902164256565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place