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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Ethicon, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antisepsis Side | Experimental | 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. |
|
| Control Side | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hypochlorite (Dakin's Solution) | Device | 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week | 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. | Approximately 1 week after surgery |
| Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week | Approximately 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drain Tubing Colonization at Removal | Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation. | Approximately two weeks after surgery |
| Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy C Degnim, M.D. | Mayo Clinic, Rochester, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94107 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23518704 | Derived | Degnim AC, Scow JS, Hoskin TL, Miller JP, Loprinzi M, Boughey JC, Jakub JW, Throckmorton A, Patel R, Baddour LM. Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. Ann Surg. 2013 Aug;258(2):240-7. doi: 10.1097/SLA.0b013e31828c0b85. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This number includes all subjects who started study therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week | 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. | 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. | Posted | Number | participants | Approximately 1 week after surgery |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Infections and infestations | Systematic Assessment | Surgical site infection per operated side within one year of operation. Includes only infections that occurred before a secondary operation such as tissue expander/implant exchange. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy C. Degnim | Mayo Clinic | 507-284-6357 | Degnim.Amy@mayo.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Chlorhexidine gluconate disk | Device | Apply one chlorhexidine disk to the intervention drain site(s) and change every three days |
|
|
| Control | Procedure | 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. |
|
| Occlusive Adhesive Dressing | Device | 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. |
|
|
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. |
| Approximately 2 weeks after surgery |
| Number of Subjects With Surgical Site Infection Within 30 Days | Approximately 30 days after surgery |
| Number of Subjects With Surgical Site Infection Within 1 Year | Approximately one year after surgery |
| Per Drain Analysis: Drain Tubing Colonization at Removal | Approximately one month after surgery |
| Per Drain Analysis: Drain Bulb Fluid Colonization at Removal | Approximately one month after surgery |
| Rochester |
| Minnesota |
| 55904 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese. | Median | Full Range | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) Class | The ASA physical status classification system is a system for assessing the fitness of cases before surgery. Class 1: Healthy person. Class 2: Mild systemic disease. Class 3: Severe systemic disease. Class 4: Severe systemic disease that is a constant threat to life. Class 5: A moribund person who is not expected to survive without the operation. Class 6: A declared brain-dead person whose organs are being removed for donor purposes. | Number | participants |
|
| Operative Time | Median | Full Range | hours |
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| Smoking within 4 weeks preoperation | Number | participants |
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| Diagnosis of diabetes | Number | participants |
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| Neoadjuvant chemotherapy | Number | participants |
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| Indication for surgery | Contralateral prophylactic mastectomy (CPM) | Number | participants |
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| Type of Preoperative Antibiotic | Number | participants |
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| Type of Operation (Antisepsis side) | Number | participants |
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| Type of Operation (Control Side) | Number | participants |
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| Type of Mastectomy (Antisepsis Side) | Number | participants |
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| Type of Mastectomy (Control Side) | Number | participants |
|
| Indication for Mastectomy (Antisepsis Side) | Number | participants |
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| Indication for Mastectomy (Control Side) | Number | participants |
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| Number of Drains (Antisepsis Side) | Number | participants |
|
| Number of Drains (Control Side) | Number | participants |
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| Type of Reconstruction (Antisepsis Side) | Number | participants |
|
| Type of Reconstruction (Control Side) | Number | participants |
|
| Acellular dermal matrix used (Antisepsis Side) | Number | participants |
|
| Acellular dermal matrix used (Control Side) | Number | participants |
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| Intraoperative Fill Volume (Antisepsis Side) | Interoperative fill volume available in n=101 participants, and missing in n=3 participants. | Median | Full Range | mL |
|
| Intraoperative Fill Volume (Control Side) | Interoperative fill volume available in n=101 participants, and missing in n=3 participants. | Median | Full Range | mL |
|
| Number of Lymph Nodes Removed (Antisepsis Side) | Among sides with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND), n=46 antisepsis side. | Median | Full Range | lymph nodes |
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| Number of Lymph Nodes Removed (Control Side) | Among sides with either SLNB or ALND, n=43 control. | Median | Full Range | lymph nodes |
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| Maximum Drain Duration (Antisepsis Side) | Maximum duration across all drains on a given side. | Median | Full Range | days |
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| Maximum Drain Duration (Control Side) | Maximum duration across all drains on a given side. | Median | Full Range | days |
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| Adjuvant Radiation Therapy (Antisepsis Side) | Adjuvant radiation therapy within one year, but prior to tissue expander exchange. | Number | participants |
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| Adjuvant Radiation Therapy (Control Side) | Adjuvant radiation therapy within one year, but prior to tissue expander exchange. | Number | participants |
|
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|
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| Secondary | Number of Subjects With Drain Tubing Colonization at Removal | Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation. | 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. | Posted | Number | participants | Approximately two weeks after surgery |
|
|
|
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| Secondary | Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal | 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. | Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection. | Posted | Number | participants | Approximately 2 weeks after surgery |
|
|
|
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| Secondary | Number of Subjects With Surgical Site Infection Within 30 Days | 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. | Posted | Number | participants | Approximately 30 days after surgery |
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|
|
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| Secondary | Number of Subjects With Surgical Site Infection Within 1 Year | Posted | Number | participants | Approximately one year after surgery |
|
|
|
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| Primary | Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week | 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. | Posted | Number | drains | Approximately 1 week after surgery | drains | Participants |
|
|
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| Secondary | Per Drain Analysis: Drain Tubing Colonization at Removal | 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. | Posted | Number | drains | Approximately one month after surgery | drains | Participants |
|
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| Secondary | Per Drain Analysis: Drain Bulb Fluid Colonization at Removal | Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection. | Posted | Number | drains | Approximately one month after surgery | drains | Participants |
|
|
|
|
| 0 |
| 104 |
| 3 |
| 104 |
| EG001 | 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. 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. | 0 | 104 | 6 | 104 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Mixed Models Analysis |
| 0.02 |
| 2-Sided |
| No |
| Superiority or Other |
| Mixed Models Analysis |
| 0.003 |
| No |
| Superiority or Other |