Trial Outcomes & Findings for Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation (NCT NCT02395614)
NCT ID: NCT02395614
Last Updated: 2022-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
6 months
Results posted on
2022-01-26
Participant Flow
Participant milestones
| Measure |
Participants Undergoing Bilateral Mastectomy
This group includes participants undergoing bilateral mastectomy with immediate breast reconstruction and tissue expander.
Each participant will receive an irrigation of chlorhexidine solution 0.05% (IrriSept, 0.05% CHG in sterile water) on one breast and an irrigation of triple antibiotic solution (composed of cefazolin, gentamicin, and bacitracin) on the other breast.
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
Chlorhexidine Irrigation
|
88
|
|
Overall Study
Triple Antibiotic Irrigation
|
88
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
Baseline characteristics by cohort
| Measure |
All Participants
n=88 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Females
|
88 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=99 Participants
|
|
BMI
|
28.2 kg/m^2
n=99 Participants
|
|
Tobacco use
|
4 Participants
n=99 Participants
|
|
Comorbidities
Diabetes
|
5 Participants
n=99 Participants
|
|
Comorbidities
Hypertension
|
15 Participants
n=99 Participants
|
|
Comorbidities
DVT
|
2 Participants
n=99 Participants
|
|
Comorbidities
Bleeding disorders
|
2 Participants
n=99 Participants
|
|
Comorbidities
No comorbidities
|
64 Participants
n=99 Participants
|
|
Indication for mastectomy
Unilateral cancer
|
71 Participants
n=99 Participants
|
|
Indication for mastectomy
Bilateral cancer
|
5 Participants
n=99 Participants
|
|
Indication for mastectomy
Bilateral risk reducing
|
12 Participants
n=99 Participants
|
|
Cancer treatment
Neoadjuvant therapy
|
2 Participants
n=99 Participants
|
|
Cancer treatment
Adjuvant radiation
|
10 Participants
n=99 Participants
|
|
Cancer treatment
Chemotherapy
|
35 Participants
n=99 Participants
|
|
Cancer treatment
None
|
41 Participants
n=99 Participants
|
|
Alcohol use
|
50 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAt 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.
Outcome measures
| Measure |
Participants Undergoing Bilateral Mastectomy
n=88 Participants
This group includes participants undergoing bilateral mastectomy with immediate breast reconstruction and tissue expander.
Each participant will receive an irrigation of chlorhexidine solution 0.05% (IrriSept, 0.05% CHG in sterile water) on one breast and an irrigation of triple antibiotic solution (composed of cefazolin, gentamicin, and bacitracin) on the other breast.
|
|---|---|
|
Number of Participants With Surgical Site Infection
Chlorhexidine irrigation
|
7 participants
|
|
Number of Participants With Surgical Site Infection
Triple antibiotic irrigation
|
4 participants
|
SECONDARY outcome
Timeframe: 6 monthsAt all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma.
Outcome measures
| Measure |
Participants Undergoing Bilateral Mastectomy
n=88 Participants
This group includes participants undergoing bilateral mastectomy with immediate breast reconstruction and tissue expander.
Each participant will receive an irrigation of chlorhexidine solution 0.05% (IrriSept, 0.05% CHG in sterile water) on one breast and an irrigation of triple antibiotic solution (composed of cefazolin, gentamicin, and bacitracin) on the other breast.
|
|---|---|
|
Number of Participants With Flap Necrosis, Hematoma, and Seroma
Chlorhexidine irrigation
|
21 participants
|
|
Number of Participants With Flap Necrosis, Hematoma, and Seroma
Triple antibiotic irrigation
|
23 participants
|
Adverse Events
Chlorhexidine Irrigation
Serious events: 0 serious events
Other events: 33 other events
Deaths: 2 deaths
Triple Antibiotic Irrigation
Serious events: 0 serious events
Other events: 29 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chlorhexidine Irrigation
n=88 participants at risk
Each patient received triple antibiotic solution on one breast and the CHG on the other breast.
CHG consisted of commercially prepared 0.05% CHG solution (IrriSept, 0.05% CHG in sterile water, Irrimax Corporation, Lawrenceville, GA.
|
Triple Antibiotic Irrigation
n=88 participants at risk
Each patient received triple antibiotic solution on one breast and the CHG on the other breast.
Triple antibiotic solution contains 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.
|
|---|---|---|
|
Infections and infestations
Surgical site infections
|
8.0%
7/88 • 20 months
|
4.5%
4/88 • 20 months
|
|
Blood and lymphatic system disorders
Necrosis/Hematoma/Seroma
|
23.9%
21/88 • 20 months
|
26.1%
23/88 • 20 months
|
|
Infections and infestations
Explantation secondary to infection
|
5.7%
5/88 • 20 months
|
2.3%
2/88 • 20 months
|
Additional Information
Dr. Kent K. Higdon
Vanderbilt university medical center
Phone: 615-936-0160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place