Trial Outcomes & Findings for Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction (NCT NCT01286168)
NCT ID: NCT01286168
Last Updated: 2014-12-19
Results Overview
Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Approximately 1 week after surgery
Results posted on
2014-12-19
Participant Flow
This study was conducted at the Mayo Clinic, Rochester, Minnesota, and the University of California, San Francisco, California. Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.
Six subjects did not start study therapy: One subject became a screen failure when her procedure was changed to a lumpectomy. For one subject, no Dakin's solution was available at the pharmacy. Four subjects withdrew, changing their minds about participating.
Participant milestones
| Measure |
Entire Study Population
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Overall Study
STARTED
|
104
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Entire Study Population
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Surgical Drains Fell Out at Home
|
2
|
Baseline Characteristics
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=104 Participants
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=5 Participants
|
|
Body Mass Index
|
23.8 kg/m^2
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Class
Class I
|
19 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Class
Class II
|
77 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) Class
Class III
|
8 participants
n=5 Participants
|
|
Operative Time
|
5.1 hours
n=5 Participants
|
|
Smoking within 4 weeks preoperation
Yes
|
4 participants
n=5 Participants
|
|
Smoking within 4 weeks preoperation
No
|
99 participants
n=5 Participants
|
|
Smoking within 4 weeks preoperation
Unknown
|
1 participants
n=5 Participants
|
|
Diagnosis of diabetes
Yes
|
3 participants
n=5 Participants
|
|
Diagnosis of diabetes
No
|
101 participants
n=5 Participants
|
|
Neoadjuvant chemotherapy
Yes
|
32 participants
n=5 Participants
|
|
Neoadjuvant chemotherapy
No
|
72 participants
n=5 Participants
|
|
Indication for surgery
Unilateral cancer with CPM
|
72 participants
n=5 Participants
|
|
Indication for surgery
Bilateral prophylactic mastectomy
|
24 participants
n=5 Participants
|
|
Indication for surgery
Bilateral cancer
|
8 participants
n=5 Participants
|
|
Type of Preoperative Antibiotic
Cefazolin
|
92 participants
n=5 Participants
|
|
Type of Preoperative Antibiotic
Clindamycin
|
6 participants
n=5 Participants
|
|
Type of Preoperative Antibiotic
Levofloxacin
|
3 participants
n=5 Participants
|
|
Type of Preoperative Antibiotic
Vancomycin
|
3 participants
n=5 Participants
|
|
Type of Operation (Antisepsis side)
Mastectomy only
|
58 participants
n=5 Participants
|
|
Type of Operation (Antisepsis side)
Mastectomy + sentinel lymph node biopsy (SLNB)
|
35 participants
n=5 Participants
|
|
Type of Operation (Antisepsis side)
Mastectomy + axillary lymph node dissection (ALND)
|
11 participants
n=5 Participants
|
|
Type of Operation (Control Side)
Mastectomy only
|
61 participants
n=5 Participants
|
|
Type of Operation (Control Side)
Mastectomy + sentinel lymph node biopsy (SLNB)
|
32 participants
n=5 Participants
|
|
Type of Operation (Control Side)
Mastectomy + axillary lymph node dissection (ALND)
|
11 participants
n=5 Participants
|
|
Type of Mastectomy (Antisepsis Side)
Skin-sparing
|
37 participants
n=5 Participants
|
|
Type of Mastectomy (Antisepsis Side)
Nipple-sparing
|
67 participants
n=5 Participants
|
|
Type of Mastectomy (Control Side)
Skin-sparing
|
36 participants
n=5 Participants
|
|
Type of Mastectomy (Control Side)
Nipple-sparing
|
68 participants
n=5 Participants
|
|
Indication for Mastectomy (Antisepsis Side)
Cancer
|
46 participants
n=5 Participants
|
|
Indication for Mastectomy (Antisepsis Side)
Risk-reducing
|
58 participants
n=5 Participants
|
|
Indication for Mastectomy (Control Side)
Cancer
|
42 participants
n=5 Participants
|
|
Indication for Mastectomy (Control Side)
Risk-reducing
|
62 participants
n=5 Participants
|
|
Number of Drains (Antisepsis Side)
1
|
52 participants
n=5 Participants
|
|
Number of Drains (Antisepsis Side)
2
|
47 participants
n=5 Participants
|
|
Number of Drains (Antisepsis Side)
3
|
5 participants
n=5 Participants
|
|
Number of Drains (Control Side)
1
|
54 participants
n=5 Participants
|
|
Number of Drains (Control Side)
2
|
42 participants
n=5 Participants
|
|
Number of Drains (Control Side)
3
|
8 participants
n=5 Participants
|
|
Type of Reconstruction (Antisepsis Side)
Tissue expander
|
95 participants
n=5 Participants
|
|
Type of Reconstruction (Antisepsis Side)
Direct-to-implant
|
9 participants
n=5 Participants
|
|
Type of Reconstruction (Control Side)
Tissue expander
|
95 participants
n=5 Participants
|
|
Type of Reconstruction (Control Side)
Direct-to-implant
|
9 participants
n=5 Participants
|
|
Acellular dermal matrix used (Antisepsis Side)
Yes
|
75 participants
n=5 Participants
|
|
Acellular dermal matrix used (Antisepsis Side)
No
|
29 participants
n=5 Participants
|
|
Acellular dermal matrix used (Control Side)
Yes
|
76 participants
n=5 Participants
|
|
Acellular dermal matrix used (Control Side)
No
|
28 participants
n=5 Participants
|
|
Intraoperative Fill Volume (Antisepsis Side)
|
150 mL
n=5 Participants
|
|
Intraoperative Fill Volume (Control Side)
|
150 mL
n=5 Participants
|
|
Number of Lymph Nodes Removed (Antisepsis Side)
|
3 lymph nodes
n=5 Participants
|
|
Number of Lymph Nodes Removed (Control Side)
|
4 lymph nodes
n=5 Participants
|
|
Maximum Drain Duration (Antisepsis Side)
|
13 days
n=5 Participants
|
|
Maximum Drain Duration (Control Side)
|
13 days
n=5 Participants
|
|
Adjuvant Radiation Therapy (Antisepsis Side)
Yes
|
7 participants
n=5 Participants
|
|
Adjuvant Radiation Therapy (Antisepsis Side)
No
|
97 participants
n=5 Participants
|
|
Adjuvant Radiation Therapy (Control Side)
Yes
|
8 participants
n=5 Participants
|
|
Adjuvant Radiation Therapy (Control Side)
No
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 1 week after surgeryPopulation: Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.
Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.
Outcome measures
| Measure |
Entire Study Population
n=101 Participants
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
Antisepsis Side
|
10 participants
|
|
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
Control Side
|
21 participants
|
PRIMARY outcome
Timeframe: Approximately 1 week after surgeryPopulation: Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.
Outcome measures
| Measure |
Entire Study Population
n=317 drains
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
Antisepsis side n=157 drains
|
11 drains
|
|
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
Control side n=160 drains
|
25 drains
|
SECONDARY outcome
Timeframe: Approximately two weeks after surgeryPopulation: Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.
Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.
Outcome measures
| Measure |
Entire Study Population
n=97 Participants
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Number of Subjects With Drain Tubing Colonization at Removal
Antisepsis Side
|
0 participants
|
|
Number of Subjects With Drain Tubing Colonization at Removal
Control Side
|
6 participants
|
SECONDARY outcome
Timeframe: Approximately 2 weeks after surgeryPopulation: Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.
Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.
Outcome measures
| Measure |
Entire Study Population
n=72 Participants
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal
Antisepsis Side
|
14 participants
|
|
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal
Control Side
|
28 participants
|
SECONDARY outcome
Timeframe: Approximately 30 days after surgeryPopulation: Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.
Outcome measures
| Measure |
Entire Study Population
n=104 Participants
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Number of Subjects With Surgical Site Infection Within 30 Days
Antisepsis Side
|
0 participants
|
|
Number of Subjects With Surgical Site Infection Within 30 Days
Control Side
|
4 participants
|
SECONDARY outcome
Timeframe: Approximately one year after surgeryOutcome measures
| Measure |
Entire Study Population
n=104 Participants
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Number of Subjects With Surgical Site Infection Within 1 Year
Antisepsis Side
|
3 participants
|
|
Number of Subjects With Surgical Site Infection Within 1 Year
Control Side
|
6 participants
|
SECONDARY outcome
Timeframe: Approximately one month after surgeryPopulation: Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.
Outcome measures
| Measure |
Entire Study Population
n=305 drains
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Per Drain Analysis: Drain Tubing Colonization at Removal
Antisepsis side, n=151 drains
|
0 drains
|
|
Per Drain Analysis: Drain Tubing Colonization at Removal
Control side, n=154
|
6 drains
|
SECONDARY outcome
Timeframe: Approximately one month after surgeryPopulation: Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.
Outcome measures
| Measure |
Entire Study Population
n=173 drains
Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
|
|---|---|
|
Per Drain Analysis: Drain Bulb Fluid Colonization at Removal
Antisepsis side, n=85 drains
|
14 drains
|
|
Per Drain Analysis: Drain Bulb Fluid Colonization at Removal
Control side, n=88 drains
|
33 drains
|
Adverse Events
Antisepsis Side
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Side
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Antisepsis Side
n=104 participants at risk
A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.
|
Control Side
n=104 participants at risk
Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.
Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.
|
|---|---|---|
|
Infections and infestations
Surgical Site Infection
|
2.9%
3/104 • Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.
All subjects underwent a mandatory follow-up visit approximately one week after surgery, at which time surgical sites are evaluated and appropriate study cultures obtained. Additional visits were made for clinical care; follow up phone calls were also made to the subjects.
|
5.8%
6/104 • Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.
All subjects underwent a mandatory follow-up visit approximately one week after surgery, at which time surgical sites are evaluated and appropriate study cultures obtained. Additional visits were made for clinical care; follow up phone calls were also made to the subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place