Breast Cancer
Conditions
Keywords
tissue expander, breast reconstruction
Brief summary
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Detailed description
Breast reconstruction with tissue expander (TE) remains the gold standard of breast restoration after mastectomy. During the first stage of reconstruction, a TE is placed under chest muscles and slowly inflated postoperatively over the period of several weeks. After desired volume of TE is achieved it is exchanged for permanent breast prosthesis during another surgery (second stage of reconstruction). Postoperative wound infection after placement of TE can lead to devastating consequences both for patients and a surgeon. Frequently, surgical site infection requires additional surgeries and resulting in the removal of TE and long term IV antibiotic therapy. Therefore, during breast reconstruction procedures all possible measures are implemented to reduce postoperative infection rate. Several studies demonstrated that intra-operative irrigation of surgical wounds with antibiotic containing solution before insertion of breast TE decreases postoperative infection rate. This approach is currently adopted as a standard of care within plastic surgery clinical community. The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction.
Interventions
\- 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles will be used to irrigate one breast pocket. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
DRUGtriple antibiotic irrigation
-triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast. 80 mg of gentamicin in 500 mL of NS. If the patient is allergic to either component - the allergen will not be used in the solution - to irrigate one breast pocket
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
* females between 18 - 81 years of age * and are undergoing bilateral mastectomy * and are candidates for immediate breast reconstruction with tissue expanders.
Exclusion criteria
* females younger than 18 and older than 81 years of age; * undergoing unilateral mastectomy and reconstruction; * bilateral reconstruction using other techniques, * patients allergic to one or more components of the antibiotic solution; * allergy to CHG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infection | 6 months | At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of SSI (cellulitis, purulent drainage). SSI was defined as any instance where antibiotics were restarted or where erythema, cellulitis, warmth, purulent drainage, or fever occurred. SSI was further classified in 3 categories: minor when requiring oral antibiotics, major when requiring inpatient intravenous antibiotics or operative washout, and finally, explantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Flap Necrosis, Hematoma, and Seroma | 6 months | At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants 88 participants were included. In each participant, 1 mastectomy pocket was randomized to TAS and the other to CHG.
CHG consisted of commercially prepared 0.05% CHG solution (IrriSept, 0.05% CHG in sterile water, IrrimaxCorporation, Lawrenceville, GA).
TAS contained 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline. | 88 |
| Total | 88 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Alcohol use | 50 Participants |
| BMI | 28.2 kg/m^2 |
| Cancer treatment Adjuvant radiation | 10 Participants |
| Cancer treatment Chemotherapy | 35 Participants |
| Cancer treatment Neoadjuvant therapy | 2 Participants |
| Cancer treatment None | 41 Participants |
| Comorbidities Bleeding disorders | 2 Participants |
| Comorbidities Diabetes | 5 Participants |
| Comorbidities DVT | 2 Participants |
| Comorbidities Hypertension | 15 Participants |
| Comorbidities No comorbidities | 64 Participants |
| Indication for mastectomy Bilateral cancer | 5 Participants |
| Indication for mastectomy Bilateral risk reducing | 12 Participants |
| Indication for mastectomy Unilateral cancer | 71 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment United States | 88 Participants |
| Sex/Gender, Customized Females | 88 Participants |
| Tobacco use | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 88 | 2 / 88 |
| other Total, other adverse events | 33 / 88 | 29 / 88 |
| serious Total, serious adverse events | 0 / 88 | 0 / 88 |
Outcome results
Primary
Number of Participants With Surgical Site Infection
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of SSI (cellulitis, purulent drainage). SSI was defined as any instance where antibiotics were restarted or where erythema, cellulitis, warmth, purulent drainage, or fever occurred. SSI was further classified in 3 categories: minor when requiring oral antibiotics, major when requiring inpatient intravenous antibiotics or operative washout, and finally, explantation.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Undergoing Bilateral Mastectomy | Number of Participants With Surgical Site Infection | Chlorhexidine irrigation | 7 participants |
| Participants Undergoing Bilateral Mastectomy | Number of Participants With Surgical Site Infection | Triple antibiotic irrigation | 4 participants |
Secondary
Number of Participants With Flap Necrosis, Hematoma, and Seroma
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Undergoing Bilateral Mastectomy | Number of Participants With Flap Necrosis, Hematoma, and Seroma | Chlorhexidine irrigation | 21 participants |
| Participants Undergoing Bilateral Mastectomy | Number of Participants With Flap Necrosis, Hematoma, and Seroma | Triple antibiotic irrigation | 23 participants |