Nonmalignant Breast ConditionsPhase 2NCT01286168

Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

A Phase 2 study testing Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk and Occlusive Adhesive Dressing in people with Nonmalignant Breast Conditions and Breast Cancer, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Nonmalignant Breast Conditions, Breast Cancer
What is being tested?: Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk and Occlusive Adhesive Dressing
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 2 sitesUnited States
Study dates: May 2011to Nov 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Mayo Clinic
Rochester, Minnesota, 55904
UCSF
San Francisco, California, 94107

Other trials in United States

About this study

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.

Read the 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.

Conditions: Nonmalignant Breast Conditions, Breast Cancer
Being tested: Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk, Control, Occlusive Adhesive Dressing
Keywords: Bilateral breast mastectomy, Immediate tissue expanders reconstruction
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium hypochlorite (Dakin's Solution)Device
Also called Dakin's solution, Wound cleanser
10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
Chlorhexidine gluconate diskDevice
Also called BioPatch Protective Disk with CHG
Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
ControlProcedure or surgery
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 DressingDevice
Also called Tegaderm CHG 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.

Study groups in NCT01286168
Study group	Role	What they receive
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. Receives: Device: Sodium hypochlorite (Dakin's Solution); Device: Chlorhexidine gluconate disk; Device: Occlusive Adhesive Dressing
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. Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Approximately 1 week after surgery
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
Measured: Approximately 1 week after surgery

Secondary outcomes (6)

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.
Measured: Approximately two weeks after surgery
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.
Measured: Approximately 2 weeks after surgery
Number of Subjects With Surgical Site Infection Within 30 Days
Measured: Approximately 30 days after surgery
Number of Subjects With Surgical Site Infection Within 1 Year
Measured: Approximately one year after surgery
Per Drain Analysis: Drain Tubing Colonization at Removal
Measured: Approximately one month after surgery
Per Drain Analysis: Drain Bulb Fluid Colonization at Removal
Measured: Approximately one month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Nov 2013

First posted31 Jan 2011 (estimated)
Study startMay 2011
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nonmalignant Breast ConditionsStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286168
Sponsor's protocol ID: 10-008061
Other IDs: UL1TR000135
Status last verified: Dec 2014
First submitted: 26 Jan 2011
Last updated: 19 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23518704

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
ClinicalTrials.gov ID: NCT01286168
Acronym / sponsor ID: 10-008061
Conditions: Nonmalignant Breast Conditions, Breast Cancer
Keywords: Bilateral breast mastectomy, Immediate tissue expanders reconstruction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: University of California, San Francisco, Ethicon, Inc.
Study start: May 2011
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 20 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Methods:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Antisepsis Side	Experimental	Device: Sodium hypochlorite (Dakin's Solution), Device: Chlorhexidine gluconate disk, Device: Occlusive Adhesive DressingA 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	Procedure: ControlStandard 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium hypochlorite (Dakin's Solution)Also: Dakin's solution, Wound cleanser10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day	Device	Antisepsis Side
Chlorhexidine gluconate diskAlso: BioPatch Protective Disk with CHGApply one chlorhexidine disk to the intervention drain site(s) and change every three days	Device	Antisepsis Side
ControlStandard 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 or surgery	Control Side
Occlusive Adhesive DressingAlso: Tegaderm CHG DressingA chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.	Device	Antisepsis Side

Primary outcome

Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week
Time frame: 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.
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week
Time frame: Approximately 1 week after surgery

6 secondary outcomes

Number of Subjects With Drain Tubing Colonization at Removal
Time frame: Approximately two weeks after surgery
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal
Time frame: Approximately 2 weeks after surgery
Number of Subjects With Surgical Site Infection Within 30 Days
Time frame: Approximately 30 days after surgery
Number of Subjects With Surgical Site Infection Within 1 Year
Time frame: Approximately one year after surgery
Per Drain Analysis: Drain Tubing Colonization at Removal
Time frame: Approximately one month after surgery
Per Drain Analysis: Drain Bulb Fluid Colonization at Removal
Time frame: Approximately one month after surgery

Results and safety

Results posted to the registry on 20 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Entire Study Population	104	101

Primary outcome: Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week

Time frame: Approximately 1 week after surgery. Number. Unit: participants

Measure	Entire Study Population n = 101
Antisepsis Side	10
Control Side	21

Entire Study Population: p = 0.02, McNemar

Population analysed: 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.

Primary outcome: Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week

Time frame: Approximately 1 week after surgery. Number. Unit: drains

Measure	Entire Study Population n = 101
Antisepsis side n=157 drains	11
Control side n=160 drains	25

Entire Study Population: p = 0.02, Mixed Models Analysis
Entire Study Population: p = 0.02, Mixed Models Analysis

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Eligible subjects were recruited prospectively from the breast surgical practices between May 2011 and June 2013.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antisepsis Side	0 of 104 (0%)	3 of 104 (2.9%)	Not reported
Control Side	0 of 104 (0%)	6 of 104 (5.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23518704Degnim 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy C Degnim, M.D. principal investigator

Mayo Clinic, Rochester, MN

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week (time frame: Approximately 1 week after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01286168, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.