Clinical trial NCT02395614
Conditions: Breast Cancer
Keywords: tissue expander breast reconstruction
Sponsor: Vanderbilt University Medical Center
Start date: 2015-12-01; Completion date: 2020-12-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.

Detailed description:
Breast reconstruction with tissue expander (TE) remains the gold standard of breast restoration after mastectomy. During the first stage of reconstruction, a TE is placed under chest muscles and slowly inflated postoperatively over the period of several weeks. After desired volume of TE is achieved it is exchanged for permanent breast prosthesis during another surgery (second stage of reconstruction). Postoperative wound infection after placement of TE can lead to devastating consequences both for patients and a surgeon. Frequently, surgical site infection requires additional surgeries and resulting in the removal of TE and long term IV antibiotic therapy. Therefore, during breast reconstruction procedures all possible measures are implemented to reduce postoperative infection rate. Several studies demonstrated that intra-operative irrigation of surgical wounds with antibiotic containing solution before insertion of breast TE decreases postoperative infection rate. This approach is currently adopted as a standard of care within plastic surgery clinical community.

The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction.

Arms: arm 1: 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast. arm 2: triple antibiotic solution will contain 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. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Interventions: intervention 1: Chlorhexidine irrigation intervention 2: triple antibiotic irrigation
Intervention descriptions: intervention 1: \- 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles will be used to irrigate one breast pocket. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast. intervention 2: -triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.

80 mg of gentamicin in 500 mL of NS. If the patient is allergic to either component - the allergen will not be used in the solution - to irrigate one breast pocket

Protocol documents:
Prot_SAP_000.pdf: 
Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
1 
Protocol Date: April 1, 2014  
 
Title: Post-Mastectomy Surgical Pocket Irrigation with Triple Antibiotic Solution vs 
Chlorhexidine Gluconate: A Randomized Controlled Trial Assessing Surgical Site 
Infections in Immediate Tissue Expander Breast Reconstruction 
 
NCT# 02395614 
 
Date: April 1, 2014 
 
 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
 
 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 Statistical Considerations 
11.0 Privacy/Confidentiality Issues 
12.0 Follow-up and Record Retention 
 
Appendices 
Appendix A Study Procedure Calendar 
 
 
 
 
 
 
 
 
 
 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
1.0 
Background 
 
Breast reconstruction with tissue expander (TE) remains widely performed 
technique of breast restoration after mastectomy.1 During first stage of reconstruction 
breast TE is placed at mastectomy site. Most commonly TE is placed into surgically 
created pocket below the pectoralis major and serratus muscles in the mastectomy wound 
(Figure 1). Alternatively, TE can be placed into subpectoral muscular pocket created with 
additional placement of acellular dermal matrix (ADM) sling (Figure 2). Regardless of 
surgical method of placement, TE is expanded gradually postoperatively over a period of 
several weeks until the desired size is achieved. Both techniques demonstrate comparable 
postoperative results including similar postoperative surgical site and tissue expander 
infection rates. 2 
The incidence of postoperative wound infection including TE infection after 
breast reconstruction ranges between 5-20% 2,3,4,6  Recently, several studies demonstrated 
that intra-operative irrigation of surgical pocket with antibiotics containing solution 
before insertion of breast TE resulted in a decrease of postoperative infection rate .5,8,9 
Irrigation of surgical wound with triple antibiotic solution (1 g of cefazolin, 50,000 U of 
bacitracin, and 80 mg of gentamicin in 500 mL of NS) was found to decrease bacterial 
growth associated with periprosthetic infections in both breast augmentation and 
reconstructive patients 5,10. The Department of Plastic Surgery at Vanderbilt University 
routinely irrigates surgically created muscular pocket with triple antibiotics solution 
before placement breast TE. This decreased the postoperative infection rate within our 
department to 14%. Despite improvement in incidence of postoperative infection after 
application of triple antibiotic solution, some authors suggested that this technique has 
several drawbacks. For example, most antimicrobials agents are effective against 
microorganisms when drug exposure occurs during bacteria’s logarithmic growth phase. 
Therefore, brief irrigation of surgical pocket with antibiotics does not provide sufficient 
contact time with bacteria in order to efficiently kill pathogenic microorganisms. 
In order to further enhance antisepsis inside surgical pocket before placing breast 
TE we purpose to use 0.05% chlorhexidine (CHG) instead of triple antibiotic solution. 
Several recent studies demonstrated exceptional antiseptic properties of CHG derivatives. 
8, 9,12-14 CHG is widely used for preparation of the surgical field and preoperative hand 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
scrubbing. It demonstrates broader bacterial coverage compared to povidone iodine based 
solutions. More recently several reports demonstrated that irrigation of chronically 
infected surgical wounds with 0.05% CHG decreases bacterial contamination without 
inhibiting wound healing or toxic side effects8. Exposure to a concentration of 0.05% 
CHG effectively produced a 5- to 6-log reduction in microbial recovery. Effective 
bacterial reduction was observed with both gram-positive and gram-negative surgical 
isolates. Specifically, antibacterial effect of CHG was prominent towards biofilm-
forming strains associated with infection of prosthetic devices such as TE.8 
We hypothesize that intraoperative irrigation of surgical pocket with 0.05% CHG 
solution before insertion of breast TE allows for more significant reduction of 
postoperative wound infection compared to similar irrigation with triple antibiotic 
solution in women undergoing bilateral TE-based breast reconstruction.  
We intend to perform a prospective randomized study and compare the incidence 
of surgical wound infection between mastectomy wounds irrigated with triple antibiotic 
solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast 
reconstruction. 
1.0  
Rationale and Specific Aims 
 
 Specific aim: to evaluate efficacy of 0.05% CHG solution to reduce 
postoperative surgical site infections compared to triple antibiotic solution in women 
undergoing breast reconstruction with TE.  
 
2.0 
Animal Studies and Previous Human Studies 
 
Antimicrobial effects of 0.05% CHG were studied both in vitro, in vivo and on 
human subjects previously 8-14. However, efficacy of this solution in decreasing incidence 
of surgical infection after breast reconstruction with TE has never been evaluated.  
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion criteria: 18-81 years old females undergoing bilateral mastectomy who 
are candidates for immediate breast reconstruction with TE (either total muscle coverage 
or ADM-based techniques). 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
Exclusion criteria: patients undergoing unilateral breast reconstruction, 
reconstruction with autologous tissue, bilateral reconstruction with other reconstructive 
techniques (autodermal flaps, etc) performed on either breast, patients allergic to one or 
more components of the antibiotic solution, patient allergic to CHG. 
 
4.0 
Enrollment/Randomization 
 
Study population  
The study is intended to be prospective randomized clinical trial.  
Randomization   
Site of application of CHG solution (either left or right surgical wound) in each 
patient will be randomly assigned by coin flipper application at random.org website 
(http://www.random.org/coins/). Triple antibiotic solution will be used on contralateral 
side and used as a control. Randomization will occur on the day of the operation. 
 
Randomization of subjects will not be performed. Each patient will serve as self-
control (contralateral surgical wound where triple antibiotic will be applied will be 
control side). 
Blinding/Data Collection 
Side of CHG application will be recorded by operating surgeon in patients 
database secured from other medical professionals participating in the study. 
Examination of reconstructed breasts will be performed by experienced clinic 
nursing staff. The site of application of the CHG solution will not be disclosed during 
clinic visit to nursing staff. The collection of data will be provided by Marcia Spear, 
DNP, ACNP-BC without knowledge of the side of CHG application. 
 Clinical data associated with the patient will be extracted form StarPanel and 
entered in a RedCap database. Collected data will include: type of infection (major or 
minor), side of occurrence, route of antibiotic administration (iv or PO), length of 
hospitalization, any surgical treatment of infected area (incision and drainage, 
debridement, TE removal), the need for long term iv antibiotic therapy, pathogen based 
on culture results, days till recovery, type and time of repeat reconstruction.  
 
5.0 
Study Procedures 
 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
Breast reconstruction in each participating patient will be performed without 
deviation from standard technique routinely performed at Department of Plastic Surgery 
at Vanderbilt University. Upon completion of mastectomy, surgical pocket will be 
created either with pectoral and serratus muscles or with pectoral muscle and ADM. 
Before insertion of breast TE, randomly selected surgical pocket (either left or right) will 
be irrigated with 500ml of 0.05% CHG solution for 1 minute. After 1 minute CHG 
solution will be aspirated and TE inserted into surgical pocket following by muscle and 
skin closure. Accordingly, contralateral site will be irrigated with triple antibiotic solution 
for 1 minute, aspirated and breast TE will be inserted and wound closed in identical 
fashion.  
 
 Drugs that will be used: 
-triple antibiotic solution: 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of 
gentamicin in 500 mL of NS. If the patient is allergic to either component – the allergen 
will not be used in the solution.  
- 0.05% chlorhexidine solution –by diluting 6.25 ml of 4% chlorhexidine in 500ml of NS 
solution (1:80).   
  
Outcome measures  
Primary outcome: 
- frequency of surgical site infection (as defined by CDC, 
http://www.cdc.gov/hai/ssi/ssi.html) 
Surgical site infection will be subdivided into “minor” infection—defined by 
clinical signs of infection successfully treated with outpatient antibiotic therapy—or 
“major” infection requiring inpatient hospitalization for intravenous antibiotic treatment 
and/or any surgical treatment.  
 
- frequency of TE infection (any infection of surgical site requiring surgical revision of 
TE) 
 
6.0 
Risks 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
We anticipate low risks given the previously demonstrated safety of CHG. 
Furthermore, minimal systemic absorption of CHG is expected since it will be used 
topically as irrigation. Allergic reaction to this drug including severe skin rash, swelling, 
trouble breathing and possibly death is rare. 
 
7.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
The progress of the study will be discussed formerly at regularly scheduled 
research meetings. These will serve as a forum for the voicing of concerns or problems 
with the study. If participant safety is a concern, the research investigators will 
immediately notify the P.I.  Adverse events will be reported to the IRB according to IRB 
policies and procedures, as there are specific guidelines at IRB Policy and Procedure 
III.L.1 that must be followed.  
  
8.0 
Study Withdrawal/Discontinuation 
 
Patient can be taken out of the study if patient is allergic to CHG and if the study 
is closed. 
 
9.0 
Statistical Considerations 
 
Sample size  
The frequency of surgical site infection in patients undergoing breast 
reconstruction is 14 %.We anticipate a 4-fold reduction on infection rate with 0.05% 
CHG down to approximately 3.5%. Using binary superiority the estimated sample size is 
110 breasts per group (110 patients) with significance b-alpha 5% and the power of 80% 
(1- beta ). http://www.sealedenvelope.com/power/binary-superiority 
 Statistical analysis  
 Categorical variables are compared using a chi-square test, and the Student t-test 
is used to compare continuous variables between groups. Logistic regression with 
adjustment for other possible risk factors is used to estimate the odds ratios and 95% 
confidence intervals. 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
10.0 Privacy/Confidentiality Issues 
Collected data will be stored in password protected database.  
 
11.0 Follow-up and Record Retention 
 
Blinding/Data Collection 
Evaluation of the wound will be performed by experienced clinic nursing staff. 
The site of application of the CHG solution will not be disclosed during clinic visit to 
nursing staff. The collection of data will be provided Marcia Spear, DNP, ACNP-BC 
without of knowledge of drug use.  
The data will be extracted form StarPanel and entered in a RedCap database. 
Collected data will include: type of infection (major or minor), side of occurrence, route 
of antibiotic administration (iv or PO), length of hospitalization, any surgical procedures 
(incision and drainage, debridement, TE removal), the need for long term iv antibiotic 
therapy, pathogen based on culture results, days till recovery, type and time of repeat 
reconstruction.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
9 
Protocol Date: April 1, 2014  
 
References: 
1. American Society of Plastic Surgeons. 2012 Plastic Surgery Statistics Report. 
American Society of Plastic Surgeons. Available at: http:// 
www.plasticsurgery.org. 
2. Reish RG, Damjanovic B, Austen WG Jr, Winograd J, Liao EC, Cetrulo CL, 
Balkin DM, Colwell AS. Infection following implant-based reconstruction in 
1952 consecutive breast reconstructions: salvage rates and predictors of success. 
Plast Reconstr Surg. 2013 Jun;131(6):1223-30. doi: 
10.1097/PRS.0b013e31828bd377. 
3. Francis, SH, Rubert, RL, Stevenson, KB, Beck, CE, Ruppert, AS, Harper, JT, 
Boehmler, JH, Miller, MJ. Independent risk factors for infection in tissue 
expander breast reconstruction. Plastic and Reconstructive Surgery.2009. 124 (6): 
1790-1796. DOI:10.1097/PRS.Ob013e3181bf80aa. 
4. Chun, YS, Verma, K., Rosen, H., Lipsitz, S., Morris, D., Kenney, P, Eriksson, E. 
Implant-based breast reconstruction using acellular dermal matrix and the risk of 
postoperative complications. Plastic and Reconstructive Surgery. 2010. 125 (2): 
429 – 436. DOI: 10.1097/PRS.0b013e318c82d90. 
5. Adams WP Jr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and 
reconstructive breast surgery using triple antibiotic breast irrigation: six-year 
prospective clinical study. Plast Reconstr Surg. 2006;118:46SY52S. 
6. Kim, JY, Davila, AA, Persing, S, Connor, CM, Jovanovic, B, Khan, S, Fine, N, 
Rawlani, V. A meta-analysis of human acellular and submuscular tissue expander 
breast reconstruction. Plastic and Reconstructive Surgery. 2012. 129 (1), 28 – 41. 
DOI:10.1097/PRS.ob01e3182361fd6. 
7. Brown NM, Cipriano CA, Moric M, Sporer SM, Della-Valle CJ. Dilute betadine 
lavage before closure for the prevention of acute postoperative deep periprosthetic 
joint infection. J Arthroplasty 2012;27:27-30. 
8. Best AJ, Nixon MF, Taylor GJ. Brief exposure of 0.05% chlorhexidine does not 
impact non-osteoarthritic human cartilage metabolism. J Hosp Infect 2007;67: 67-
71. 
9. Edmiston, CE, Bruden, B, Rucinski, MC, Henen, C, Graham, MB, Lewis, BL. 
Reducing the risk of surgical site infections: does chlorhexidine gluconate provide 
a risk reduction benefit? American Journal of Infection Control. 2013. 41 (5S): 
S49 – 55. Doi: 10.1016/j.ajic.2012.10.030. 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
10. Adams WP Jr, Conner WC, Barton FE Jr, et al. Optimizing breast pocket 
irrigation: an in vitro study and clinical implications. Plast Reconstr 
Surg.2000;105:334Y338; discussion 339Y343 
 
11. http://www.sealedenvelope.com/power/binary-superiority/ 
12. Crowley, DJ, Kanakaris, NK, Gionnoudis, PV. Irrigation of wounds in open 
fractures. Journal of Bone and Joint Surgery. 2007. 89B (5), 580 – 585. DOI: 
10.1302/0301-620X.89B5. 
13. Han, Y, Giannitsios, D, Duke, K, Steffen, T, Burman, M. Biomedical analysis of 
chlorhexidine power irrigation to disinfect contaminated anterior cruciate 
ligament grafts. American Journal of Sports Medicine. 2012. 39: 1528 – 1533. 
14. Culligan, PJ, Kubik, K, Murphy, M, Blackwell, Snyder, J. A randomized triat that 
compared povidone iodine and chlorhexidine as antiseptics for vaginal 
hysterectomy. Obstetrics and Gynecology. 2005. 192: 422-425. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Kye Higdon, MD Department of Plastic Surgery  
Protocol Version #1 
 
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Protocol Date: April 1, 2014  
Figure 1. TE-based breast reconstruction with creation of pectoral and serratus muscles 
pocket.  
 
 
 
 
 
 
Figure 2. TE-based breast reconstruction with creation of surgical pocket with ADM 
sling 
 
 
 
ADM sling 

ICF_001.pdf: 
Vanderbilt University Institutional Review Board 
Informed Consent Document for Research 
 
Principal Investigator:  Kent Higdon, MD 
     
Version Date: June 20, 2018  
Study Title: Incidence of surgical site infection after irrigation of surgical pocket with 0.05% chlorhexidine compared to triple antibiotic 
solution in post-mastectomy breast reconstruction 
Institution/Hospital:  Vanderbilt University Medical Center 
 
1 of 5 
 
Title: Post-Mastectomy Surgical Pocket Irrigation with Triple Antibiotic Solution vs Chlorhexidine 
Gluconate: A Randomized Controlled Trial Assessing Surgical Site Infections in Immediate Tissue 
Expander Breast Reconstruction 
 
NCT# 02395614 
 
Date: June 20, 2018 


Vanderbilt University Institutional Review Board 
Informed Consent Document for Research 
 
Principal Investigator:  Kent Higdon, MD 
     
Version Date: June 20, 2018  
Study Title: Incidence of surgical site infection after irrigation of surgical pocket with 0.05% chlorhexidine compared to triple antibiotic 
solution in post-mastectomy breast reconstruction 
Institution/Hospital:  Vanderbilt University Medical Center 
 
2 of 5 
This informed consent applies to Adults 
 
 
Name of participant: _________________________________________________________ Age: ___________ 
 
The following is given to you to tell you about this research study.  Please read this form with care and ask any questions you 
may have about this study.  Your questions will be answered.  Also, you will be given a copy of this consent form.   
 
You do not have to be in this research study. You may choose not to be in this study and get other treatments without changing your 
healthcare, services or other rights.  You can stop being in this study at any time.  If we learn something new that may affect the risks or 
benefits of this study, you will be told so that you can decide whether or not you still want to be in this study.   Your medical record will 
contain a note saying you are in a research study.  Anyone you authorize to receive your medical record will also get this note. 
 
     
1. What is the purpose of this study?  
 
  The purpose of the study is to evaluate whether wash out of surgical wounds with 0.05% chlorhexidine gluconate 
(CHG) solution is superior to washout with triple antibiotic solution in reduction of postoperative infection in patients 
undergoing placement of breast tissue expanders.  
 
2. What will happen and how long will you be in the study? 
 
You are being asked to take part in this research study because you are having bilateral breast reconstruction with 
insertion of tissue expanders. This research study will compare two methods of washout of your pocket for the 
placement of the tissue expander during your operation.  The traditional method involves using a triple antibiotic 
solution containing cefazolin, bacitracin, and gentamicin, all commonly used antibiotics.  The use of chlorhexidine 
gluconate and cefazolin, bacitracin, and gentamicin for this indication is not approved by the FDA. We propose  that 0.05% CHG 
solution is more effective as a solution used to sanitize the wound in reducing risk of postoperative wound infection.  CHG 
is one of the most commonly used antiseptics for hand scrubbing and surgical prep. We will be using a commercially 
prepared 0.05% CHG solution known as IrriSept® (IrriMax Corporation; Lawrenceville, GA) that is packaged for use in 
sterile environments such as surgery. A solution of 0.05% CHG will be directed to irrigate one side of your breast and 
the other side will be irrigated with the triple antibiotic solution.  The side to receive the chlorhexidine solution will be 
randomly selected like the flip of a coin; the opposite side will receive the triple antibiotic solution.  The study will assess 
the frequency and severity of any surgical site infection between the two methods. There will be a total of 110 women 
entered into the study.  You will have your breast reconstruction surgery using tissue expanders as planned. You will 
not be required to visit the office more frequently because of your participation.  Your involvement will last for 6 months 
following your reconstruction. There will not be anything different in your intraoperative or postoperative care as a result 
of your participation in this study.  
 
3. Costs to you if you take part in this study: 
 
If you agree to take part in this research study, you and/or your insurance will not have to pay for the tests and 
treatments that are being done only for research. 
However, you are still responsible for paying for the usual care you would normally receive for the treatment of your 
illness. This includes treatments and tests you would need even if you were not in this study. These costs will be 
billed to you and/or your insurance.  


Vanderbilt University Institutional Review Board 
Informed Consent Document for Research 
 
Principal Investigator:  Kent Higdon, MD 
     
Version Date: June 20, 2018  
Study Title: Incidence of surgical site infection after irrigation of surgical pocket with 0.05% chlorhexidine compared to triple antibiotic 
solution in post-mastectomy breast reconstruction 
Institution/Hospital:  Vanderbilt University Medical Center 
 
3 of 5 
You have the right to ask what it may cost you to take part in this study. If you would like assistance, financial 
counseling is available through the Vanderbilt Financial Assistance Program.  The study staff can help you contact 
this program. You have the right to contact your insurance company to discuss the costs of your routine care (non-
research) further before choosing to be in the study. You may choose not to be in this study if your insurance does 
not pay for your routine care (non-research) costs and your doctor will discuss other treatment plans with you. 
 
4. Side effects and risks that you can expect if you take part in this study:  
 
We anticipate low risk to you given the history of the safety of chlorhexidine gluconate as there will be minimal 
systemic absorption since it will be used topically as irrigation.  
 
Side effects with chlorhexidine gluconate include: 
Uncommon side effects include local irritation and allergic-type symptoms including erythema or redness of the skin 
or rash. 
A very serious allergic reaction to this drug including severe skin rash, swelling, trouble breathing and possibly 
death is rare. 
 
      
 
5. Risks that are not known: 
 
Although the use of chlorhexidine is FDA cleared for cleansing and irrigation, there may be risks that we do not know 
about at this time.   
 
 
6.  Payment in case you are injured because of this research study: 
 
If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests or 
treatments that are done for research, then you and/or your insurance will not have to pay for the cost of immediate 
medical care provided at Vanderbilt to treat the injury.  
 
There are no plans for Vanderbilt to pay for the costs of any additional care. There are no plans for Vanderbilt to 
give you money for the injury.  
 
6. Good effects that might result from this study:  
 
a) The benefits to science and humankind that might result from this study are: If this study shows that the use 
of chlorhexidine gluconate as irrigation for tissue expander implantation provides increased antimicrobial coverage, 
many other women may benefit from this procedure in the future.   
b) The benefits you might get from being in this study are: there is no known benefit to you for your being in this 
study. 
.       
 
8.  Other treatments you could get if you decide not to be in this study: 
   
You do not have to participate in this study to receive treatment for your condition. Alternatives include standard of 
care with the current triple antibiotic irrigation used for both sides of your reconstruction.  
  


Vanderbilt University Institutional Review Board 
Informed Consent Document for Research 
 
Principal Investigator:  Kent Higdon, MD 
     
Version Date: June 20, 2018  
Study Title: Incidence of surgical site infection after irrigation of surgical pocket with 0.05% chlorhexidine compared to triple antibiotic 
solution in post-mastectomy breast reconstruction 
Institution/Hospital:  Vanderbilt University Medical Center 
 
4 of 5 
 
9.  Payments for your time spent taking part in this study or expenses: 
 
There will be no payment for participation in this study 
 
10. Reasons why the study doctor may take you out of this study:        
 You may be taken out of the study without your consent by the study doctor, for example, if the doctor finds out you are 
allergic to chlorhexidine.  If you are taken out of the study, you will be told the reason why. 
 
11. What will happen if you decide to stop being in this study? 
 
If you decide to stop being part of the study, you should tell your study doctor.  Deciding to not be part of the study will 
not change your regular medical care in any way. 
 
 
 
12. Who to call for any questions or in case you are injured: 
 
 If you should have any questions about this research study or if you feel you have been hurt by being a part of this 
study, please feel free to contact Kent Higdon, MD 
 
For additional information about giving consent or your rights as a person in this study, to discuss problems, concerns, 
and questions, or to offer input, please feel free to call the Vanderbilt University Institutional Review Board Office at 
(615) 322-2918 or toll free at (866) 224-8273. 
 
13. Clinical Trials Registry.   
 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law.  This Web site will 
not include information that can identify you.  At most, the Web site will include a summary of the results.  You can 
search this Web site at any time. 
 
14. Confidentiality:   
 
Data will be collected and stored in a pass-word protected computer database. Only your study doctor and study   
personnel will have access to the database. Upon completion of the study, the database will be kept by the study 
physician under the same password protection and will oversee along with the study coordinator adherence to the study 
protocol, protection of patient confidentiality, and reporting of all adverse events to the IRB according to IRB policies 
and procedures. 
 
Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this 
form. Vanderbilt, Dr. Higdon and his staff will comply with any and all laws regarding the privacy of such information.  
There are no plans to pay you for the use or transfer of this de-identified information. 
 
 
15. Authorization to Use/Disclose Protected Health Information 
 
All efforts, within reason, will be made to keep your protected health information (PHI) private. PHI is your health 
information that is, or has been gathered or kept by Vanderbilt as a result of your healthcare.  This includes data gathered 
for research studies that can be traced back to you.  Using or sharing (“disclosure”) such data must follow federal privacy 


Vanderbilt University Institutional Review Board 
Informed Consent Document for Research 
 
Principal Investigator:  Kent Higdon, MD 
     
Version Date: June 20, 2018  
Study Title: Incidence of surgical site infection after irrigation of surgical pocket with 0.05% chlorhexidine compared to triple antibiotic 
solution in post-mastectomy breast reconstruction 
Institution/Hospital:  Vanderbilt University Medical Center 
 
5 of 5 
rules. By signing the consent for this study, you are agreeing (“authorization”) to the uses and likely sharing of your PHI.  If 
you decide to be in this research study, you are also agreeing to let the study team use and share your PHI as described 
below.  
 
As part of the study, Dr. Higdon and his study team may share the results of your study and/or non-study linked information 
including laboratory results as well as parts of your medical record, to the groups named below. These groups may include 
people from the Federal Government Office for Human Research Protections, the Vanderbilt University Institutional Review 
Board, the Food and Drug Administration.  Federal privacy rules may not apply to these groups; they have their own rules 
and codes to assure that all efforts, within reason, will be made to keep your PHI private.  
 
The study results will be kept in your research record for at least six years after the study is finished.  At that time, the 
research data that has not been put in your medical record will be kept for an unknown length of time.  Any research data 
that has been put into your medical record will be kept for an unknown length of time. 
 
Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask that you 
contact Dr. Higdon in writing and let him know that you withdraw your consent.  His mailing address is D-4207 MCN, 
Nashville, TN  37232.  At that time, we will stop getting any more data about you.  But, the health data we stored before you 
withdrew your consent may still be used for reporting and research quality. 
 
 
 
If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment in any 
health plans or affect your ability to get benefits. You will get a copy of this form after it is signed.  
 
 
 
STATEMENT BY PERSON AGREEING TO BE IN THIS STUDY 
 
I have read this consent form and the research study has been explained to me verbally.  All my questions 
have been answered, and I freely and voluntarily choose to take part in this study.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
Signature of patient/volunteer 
 
 
 
 
 
Consent obtained by: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______________ 
 
 
 
 
Printed Name and Title  
 
 
 
 
Time