Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01286168
• Collaborator: University of California, San Francisco (Other), Ethicon, Inc. (Industry)
• Enrollment: 110
• Locations: 2
• Arms: 2
• Duration (Months): 30.1
• Patients Per Site: 55
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.

Condition or Disease	Intervention/Treatment	Phase
Nonmalignant Breast Conditions; Breast Cancer	Device: Sodium hypochlorite (Dakin's Solution); Device: Chlorhexidine gluconate disk; Procedure: Control; Device: Occlusive Adhesive Dressing	Phase 2

Detailed Description

Surgical Site infection after breast surgical procedures occurs more frequently than for other clean surgical procedures. Considering the large numbers of patients who undergo breast-related procedures per year and the increasing use of immediate breast reconstruction with placement of tissue expanders or immediate implant reconstruction, a surgical site infection involving the implant can result in its removal and a failed reconstruction.

The primary aim of the study is to determine if chlorhexidine disk application and irrigation of the drainage bulb with dilute Dakin's solution (buffered sodium hypochlorite solution)after tissue expander breast reconstruction or immediate implant reconstruction, effectively decreases rates of bacterial colonization in drain fluid compared to standard care.

Methods:

Patients undergoing bilateral immediate reconstruction with tissue expander placement will have one surgical site treated with standard drain care and the other treated with a drain antisepsis regimen. Drain antisepsis intervention will consist of two measures: 1) placement of a chlorhexidine sponge dressing at the drain exit site, and 2) twice daily irrigation of the drainage bulb with dilute Dakin's solution (buffered hypochlorite).

All patients will undergo semiquantitative cultures of the drain bulb at one week postoperatively. This culture will be repeated at the time of drain removal, with simultaneous cultures of the fluid in the bulb as well as an internal segment of each removed drainage tube. All patients will be evaluated for clinical signs of infection and for any adverse reactions to the drain antisepsis at the follow-up visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antisepsis Side 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.	Device: Sodium hypochlorite (Dakin's Solution); 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day; Other Names: Dakin's solution Wound cleanser ; Device: Chlorhexidine gluconate disk; Apply one chlorhexidine disk to the intervention drain site(s) and change every three days; Other Names: BioPatch Protective Disk with CHG ; Device: 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.; Other Names: Tegaderm CHG Dressing
Other: Control Side 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week [Approximately 1 week after surgery]

   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.

2. Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week [Approximately 1 week after surgery]

Secondary Outcome Measures

1. Number of Subjects With Drain Tubing Colonization at Removal [Approximately two weeks after surgery]

   Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.

2. Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal [Approximately 2 weeks after surgery]

   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.

3. Number of Subjects With Surgical Site Infection Within 30 Days [Approximately 30 days after surgery]

4. Number of Subjects With Surgical Site Infection Within 1 Year [Approximately one year after surgery]

5. Per Drain Analysis: Drain Tubing Colonization at Removal [Approximately one month after surgery]

6. Per Drain Analysis: Drain Bulb Fluid Colonization at Removal [Approximately one month after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Females or males age 18-90 able to give informed consent

• Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction

• May have either malignant or benign breast condition

Exclusion Criteria:

• Antibiotic use in the fourteen days prior to surgical date

• Undergoing unilateral tissue expander reconstruction

• Documented allergy to chlorhexidine gluconate

• Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease)

• Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin

• Pregnant women

• Vulnerable subjects - prisoners, institutionalized individuals

• Non-English speaking patients without adequate interpreter assistance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF	San Francisco	California	United States	94107
2	Mayo Clinic	Rochester	Minnesota	United States	55904

Sponsors and Collaborators

• Mayo Clinic
• University of California, San Francisco
• Ethicon, Inc.

Investigators

• Principal Investigator: Amy C Degnim, M.D., Mayo Clinic, Rochester, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy C. Degnim, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01286168
• Other Study ID Numbers: 10-008061; UL1TR000135
• First Posted: Jan 31, 2011
• Last Update Posted: Dec 19, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Amy C. Degnim, MD, Mayo Clinic: Bilateral breast mastectomy; Immediate tissue expanders reconstruction
• Additional relevant MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Sodium Hypochlorite; Eusol; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Period Title: Overall Study
STARTED	104
COMPLETED	101
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	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 Participants	104
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	46
Sex: Female, Male (Count of Participants)
Female	104 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	104 100%
Body Mass Index (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	23.8
American Society of Anesthesiologists (ASA) Class (participants) [Number]
Class I	19 18.3%
Class II	77 74%
Class III	8 7.7%
Operative Time (hours) [Median (Full Range) ]
Median (Full Range) [hours]	5.1
Smoking within 4 weeks preoperation (participants) [Number]
Yes	4 3.8%
No	99 95.2%
Unknown	1 1%
Diagnosis of diabetes (participants) [Number]
Yes	3 2.9%
No	101 97.1%
Neoadjuvant chemotherapy (participants) [Number]
Yes	32 30.8%
No	72 69.2%
Indication for surgery (participants) [Number]
Unilateral cancer with CPM	72 69.2%
Bilateral prophylactic mastectomy	24 23.1%
Bilateral cancer	8 7.7%
Type of Preoperative Antibiotic (participants) [Number]
Cefazolin	92 88.5%
Clindamycin	6 5.8%
Levofloxacin	3 2.9%
Vancomycin	3 2.9%
Type of Operation (Antisepsis side) (participants) [Number]
Mastectomy only	58 55.8%
Mastectomy + sentinel lymph node biopsy (SLNB)	35 33.7%
Mastectomy + axillary lymph node dissection (ALND)	11 10.6%
Type of Operation (Control Side) (participants) [Number]
Mastectomy only	61 58.7%
Mastectomy + sentinel lymph node biopsy (SLNB)	32 30.8%
Mastectomy + axillary lymph node dissection (ALND)	11 10.6%
Type of Mastectomy (Antisepsis Side) (participants) [Number]
Skin-sparing	37 35.6%
Nipple-sparing	67 64.4%
Type of Mastectomy (Control Side) (participants) [Number]
Skin-sparing	36 34.6%
Nipple-sparing	68 65.4%
Indication for Mastectomy (Antisepsis Side) (participants) [Number]
Cancer	46 44.2%
Risk-reducing	58 55.8%
Indication for Mastectomy (Control Side) (participants) [Number]
Cancer	42 40.4%
Risk-reducing	62 59.6%
Number of Drains (Antisepsis Side) (participants) [Number]
1	52 50%
2	47 45.2%
3	5 4.8%
Number of Drains (Control Side) (participants) [Number]
1	54 51.9%
2	42 40.4%
3	8 7.7%
Type of Reconstruction (Antisepsis Side) (participants) [Number]
Tissue expander	95 91.3%
Direct-to-implant	9 8.7%
Type of Reconstruction (Control Side) (participants) [Number]
Tissue expander	95 91.3%
Direct-to-implant	9 8.7%
Acellular dermal matrix used (Antisepsis Side) (participants) [Number]
Yes	75 72.1%
No	29 27.9%
Acellular dermal matrix used (Control Side) (participants) [Number]
Yes	76 73.1%
No	28 26.9%
Intraoperative Fill Volume (Antisepsis Side) (mL) [Median (Full Range) ]
Median (Full Range) [mL]	150
Intraoperative Fill Volume (Control Side) (mL) [Median (Full Range) ]
Median (Full Range) [mL]	150
Number of Lymph Nodes Removed (Antisepsis Side) (lymph nodes) [Median (Full Range) ]
Median (Full Range) [lymph nodes]	3
Number of Lymph Nodes Removed (Control Side) (lymph nodes) [Median (Full Range) ]
Median (Full Range) [lymph nodes]	4
Maximum Drain Duration (Antisepsis Side) (days) [Median (Full Range) ]
Median (Full Range) [days]	13
Maximum Drain Duration (Control Side) (days) [Median (Full Range) ]
Median (Full Range) [days]	13
Adjuvant Radiation Therapy (Antisepsis Side) (participants) [Number]
Yes	7 6.7%
No	97 93.3%
Adjuvant Radiation Therapy (Control Side) (participants) [Number]
Yes	8 7.7%
No	96 92.3%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
Description	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.
Time Frame	Approximately 1 week after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	101
Antisepsis Side	10 9.6%
Control Side	21 20.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	McNemar
	Comments

2. Secondary Outcome

Title	Number of Subjects With Drain Tubing Colonization at Removal
Description	Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.
Time Frame	Approximately two weeks after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	97
Antisepsis Side	0 0%
Control Side	6 5.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	McNemar
	Comments

3. Secondary Outcome

Title	Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal
Description	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.
Time Frame	Approximately 2 weeks after surgery

Outcome Measure Data

Analysis Population Description

Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	72
Antisepsis Side	14 13.5%
Control Side	28 26.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	McNemar
	Comments

4. Secondary Outcome

Title	Number of Subjects With Surgical Site Infection Within 30 Days
Time Frame	Approximately 30 days after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	104
Antisepsis Side	0 0%
Control Side	4 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	McNemar
	Comments

5. Secondary Outcome

Title	Number of Subjects With Surgical Site Infection Within 1 Year
Time Frame	Approximately one year after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	104
Antisepsis Side	3 2.9%
Control Side	6 5.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	McNemar
	Comments

6. Primary Outcome

Title	Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
Time Frame	Approximately 1 week after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	101
Measure drains	317
Antisepsis side n=157 drains	11
Control side n=160 drains	25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

Title	Per Drain Analysis: Drain Tubing Colonization at Removal
Time Frame	Approximately one month after surgery

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	97
Measure drains	305
Antisepsis side, n=151 drains	0
Control side, n=154	6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Likelihood-ratio test
	Comments

8. Secondary Outcome

Title	Per Drain Analysis: Drain Bulb Fluid Colonization at Removal
Time Frame	Approximately one month after surgery

Outcome Measure Data

Analysis Population Description

Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.

Arm/Group Title	Entire Study Population
Arm/Group Description	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.
Measure Participants	72
Measure drains	173
Antisepsis side, n=85 drains	14
Control side, n=88 drains	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Entire Study Population
	Comments	Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.
Adverse Event Reporting Description	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.
Arm/Group Title	Antisepsis Side		Control Side
Arm/Group Description	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.		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.
All Cause Mortality
	Antisepsis Side		Control Side
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Antisepsis Side		Control Side
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	Antisepsis Side		Control Side
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/104 (2.9%)		6/104 (5.8%)
Infections and infestations
Surgical Site Infection	3/104 (2.9%)		6/104 (5.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.