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Trial registered on ANZCTR


Registration number
ACTRN12611000701921
Ethics application status
Approved
Date submitted
11/06/2011
Date registered
8/07/2011
Date last updated
19/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single-Dose versus Long-Term Antibiotic Prophylaxis for Breast Reconstruction with Tissue Expanders
Scientific title
Infection Rates in Patients Receiving Single-Dose or Long-Term Antibiotic Prophylaxis for Breast Reconstruction with Tissue Expanders
Secondary ID [1] 262362 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infection 268066 0
Condition category
Condition code
Infection 268211 268211 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Single Perioperative Antibiotic Dose. Patients received 1-2 grams of cefazolin intravenously within 30 minutes prior to surgery, based on the participant’s weight (1 gram for less than 100 kg & 2 grams for greater than 100 kg).

Arm 2: Prolonged Antibiotic Dose. Patients also received 1-2 grams of cefazolin intravenously within 30 minutes prior to surgery, based on the participant’s weight (1 gram for less than 100 kg & 2 grams for greater than 100 kg). After surgery patients received an additional 24 hours of intravenous dosing of cefazolin and then seven days of cephalexin 500 mg by mouth 3-4 times per day as directed.
Intervention code [1] 266755 0
Prevention
Intervention code [2] 266756 0
Treatment: Drugs
Comparator / control treatment
Dose Comparison - Arm 2: Prolonged Antibiotic Dose
Control group
Dose comparison

Outcomes
Primary outcome [1] 268948 0
Primary Outcome 1: Superficial Surgical Site Infection as defined by the Centers for Disease Control (CDC)
Timepoint [1] 268948 0
Timepoint: At 2 and 6 weeks and 3 months post-operation
Secondary outcome [1] 276672 0
Nil
Timepoint [1] 276672 0
Nil

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18
2. Female
3. Patients undergoing mastectomy with immediate breast reconstruction with tissue expanders
4. Patients who sign informed consent
5. Patients who do not meet any of the exclusion criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age less than or equal to 17
2. Patients with ongoing systemic infection at the time of surgery
3. Patients who are pregnant or planning to become pregnant
4. Patients allergic to cephalosporins

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
From October 2008 to December 2010 all patients presenting to 3 breast surgeons' clinic whose disease necessitated either single or bilateral mastectomy and who elected to have immediate breast reconstruction with tissue expanders were screened for inclusion and exclusion criteria. Once a potential study participant was identified, a member of the research team approached the patient with regard to inclusion in this study during their pre-surgical consultation with the breast surgeon. During the consultation, patients were given an informed consent document, and had the study explained to them. Those patients wishing to participate in the study and meeting inclusion criteria were then stratified to receive either a single dose of antibiotics prior to surgery or seven days of oral antibiotics in addition to the dose given prior to surgery.

Allocation to study treatment was concealed. Members of the study team responsible for determining inclusion eligibility were unaware of which group the subject would be allocated. Individuals enrolling study participants contacted a single study investigator, located off-site, for randomization to a study arm. This investigator was solely responsible for maintaining the randomization list and assigning patients to study groups and was not involved in subject screening or in subject consenting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number table was used to generate random number sequences for each block. Then the numbers were divided into 3 digit numbers and treatment A assigned to the first 5 numbers in the sequence and treatment B assigned to the last 5 numbers in the sequence. Four blocks of random sequences were prepared for each plastic surgeon participating in the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3625 0
United States of America
State/province [1] 3625 0

Funding & Sponsors
Funding source category [1] 267237 0
Self funded/Unfunded
Name [1] 267237 0
Address [1] 267237 0
Country [1] 267237 0
Primary sponsor type
University
Name
The University of Kansas School of Medicine - Wichita
Address
1010 N. Kansas
Wichita, KS 67214
Country
United States of America
Secondary sponsor category [1] 266302 0
None
Name [1] 266302 0
Address [1] 266302 0
Country [1] 266302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269228 0
The University of Kansas School of Medicine - Wichita Human Subjects Committee 2
Ethics committee address [1] 269228 0
The University of Kansas School of Medicine - Wichita
Office of Compliance
1010 N. Kansas
Wichtia, KS 67214-3199
Ethics committee country [1] 269228 0
United States of America
Date submitted for ethics approval [1] 269228 0
03/03/2008
Approval date [1] 269228 0
13/05/2008
Ethics approval number [1] 269228 0
220081105
Ethics committee name [2] 269229 0
Via Christi Regional Medical Center Institutional Review Board
Ethics committee address [2] 269229 0
Medical Staff Administration
Via Christi Regional Medical Center
929 N. Saint Francis
Wichita, KS 67214
Ethics committee country [2] 269229 0
United States of America
Date submitted for ethics approval [2] 269229 0
29/02/2008
Approval date [2] 269229 0
27/03/2008
Ethics approval number [2] 269229 0
Ethics committee name [3] 269230 0
Wichita Medical Research & Education Foundation Institutional Review Board
Ethics committee address [3] 269230 0
Wichita Medical Research & Education Foundation
3306 E. Central
Wichita, KS 67208
Ethics committee country [3] 269230 0
United States of America
Date submitted for ethics approval [3] 269230 0
24/07/2007
Approval date [3] 269230 0
02/09/2008
Ethics approval number [3] 269230 0
1/08/0035

Summary
Brief summary
This small study did not reveal a significant difference between single-dose versus long-term antibiotic prophylaxis, although all infections occurred in patients in the single-dose antibiotic group. Further studies are needed to determine whether the common practice of prolonged antibiotic use after immediate reconstruction with tissue expanders is beneficial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32733 0
Address 32733 0
Country 32733 0
Phone 32733 0
Fax 32733 0
Email 32733 0
Contact person for public queries
Name 15980 0
Stephen D. Helmer, Ph.D.
Address 15980 0
Department of Surgery, Room 3082
The University of Kansas School of Medicine - Wichita
929 N. Saint Francis St.
Wichita, KS 67214
Country 15980 0
United States of America
Phone 15980 0
1 316 2685457
Fax 15980 0
1 316 2917662
Email 15980 0
Stephen.Helmer@viachristi.org
Contact person for scientific queries
Name 6908 0
Stephen D. Helmer, Ph.D.
Address 6908 0
Department of Surgery, Room 3082
The University of Kansas School of Medicine - Wichita
929 N. Saint Francis St.
Wichita, KS 67214
Country 6908 0
United States of America
Phone 6908 0
1 316 2685457
Fax 6908 0
1 316 2917662
Email 6908 0
Stephen.Helmer@viachristi.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary