An interventional study of Chlorhexidine irrigation and triple antibiotic irrigation in Breast Cancer, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 81 Years. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 88 is below the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Drug: Chlorhexidine irrigation
triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline (NS). If the patient is allergic to either component - the allergen will not be used in the solution - for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Drug: triple antibiotic irrigation
- 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.
Also known as: CHG
-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
Also known as: gentamicin, cefazolin and bacitracin
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
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
| Milestone | Participants Undergoing Bilateral Mastectomy |
|---|---|
| Started | 88 |
| Chlorhexidine irrigation | 88 |
| Triple antibiotic irrigation | 88 |
| Completed | 88 |
| Not completed | 0 |
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.
| participants | Participants Undergoing Bilateral Mastectomy |
|---|---|
| Chlorhexidine irrigation | 7 |
| Triple antibiotic irrigation | 4 |
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma.
| participants | Participants Undergoing Bilateral Mastectomy |
|---|---|
| Chlorhexidine irrigation | 21 |
| Triple antibiotic irrigation | 23 |
Collected over 20 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chlorhexidine Irrigation | 2/88 (2.3%) | 0/88 (0%) | 33/88 (37.5%) |
| Triple Antibiotic Irrigation | 2/88 (2.3%) | 0/88 (0%) | 29/88 (33%) |
| Event | Chlorhexidine Irrigation | Triple Antibiotic Irrigation |
|---|---|---|
| Necrosis/Hematoma/SeromaBlood and lymphatic system disorders | 21/88 | 23/88 |
| Surgical site infectionsInfections and infestations | 7/88 | 4/88 |
| Explantation secondary to infectionInfections and infestations | 5/88 | 2/88 |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 88 |
| >=65 years | 0 |
| Sex/Gender, Customized(Participants) | All Participants |
|---|---|
| Females | 88 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 81 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 88 |
| BMI(kg/m^2) | All Participants |
|---|---|
| Mean | 28.2 (23.5 to 32.4) |
| Tobacco use(Participants) | All Participants |
|---|---|
| Count of participants | 4 |
| Comorbidities(Participants) | All Participants |
|---|---|
| Diabetes | 5 |
| Hypertension | 15 |
| DVT | 2 |
| Bleeding disorders | 2 |
| No comorbidities | 64 |
| Indication for mastectomy(Participants) | All Participants |
|---|---|
| Unilateral cancer | 71 |
| Bilateral cancer | 5 |
| Bilateral risk reducing | 12 |
2 further baseline measures are reported on the registry.
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Vanderbilt University Medical Center