Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Phase: NA
Conditions: Complications Wounds, Negative Pressure Wound Therapy, Wound Healing Delayed, Incisional, Panniculectomy, Incisional Negative Pressure Wound Therapy, Incisional Vac, Wound Vac, Obese, Renal Failure, Kidney Transplant; Complications, Wound Healing Complication
Sponsor: University of California, Davis

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1) 
Protocol Title 
a) Incisional Negative Pressure Wound Therapy in High Risk Patients 
Undergoing Panniculectomy:  A Prospective Randomized Controlled 
Trial 10/25/2015 
b) Chad M. Bailey, MD; Yunfeng, Xue, MD; Michael S. Wong, MD (PI) 
 
2) 
IRB Review History 
NA 
3) 
Objectives 
Aim:  to evaluate benefits of PICO in high-risk panniculectomy patients in preparation 
for renal transplant. 
Objectives:  Evaluate wound healing complications and overall morbidity as well as scar 
quality and quality of life in high-risk patients who undergo panniculectomy in 
preparation for renal transplant with and without PICO therapy measuring the following 
endpoints: 
1) Primary:  wound healing complications 
2) Secondary:  drainage, hematoma, seroma 
3) Tertiary: scar (Vancouver scar scale), pain (visual analog scale, narcotic use), 
quality of life (SF-36) 
 
4) 
Background 
Incisional negative pressure therapy (INPWT) has previously been shown in certain 
patient populations to decrease wound healing complications, decrease the rate of 
hematomas and seromas, as well as have better scar quality. We have found a group 
of patients, those who have panniculectomies in preparation for renal transplant, 
with significantly higher rates of wound healing complications (Bailey et al, Ann 
Plast Surg. 2015 May;74suppl 1:S9-11.). We believe the best way to demonstrate 
benefits of incisional negative pressure wound therapy will be in this group of 
patients known to have significantly higher rates of wound complications. 
 
5) 
Inclusion and Exclusion Criteria 
Inclusion criteria:  All patients undergoing panniculectomy in preparation 
for renal transplantation at the University of California Davis Medical 
Center.  Patients who are entered into the trial and have 30 days of follow 
up, and those in the INPWT study arm who successfully complete 7 days 
of treatment, will be included. 
 
Exclusion criteria:  All patients who previously demonstrated a 
hypersensitivity reaction to adhesives and qualify for panniculectomy in 
preparation for renal transplantation, or all patients who are undergoing 
panniculectomy for reasons other than in preparation for renal 

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transplantation (i.e. after massive weight loss or for cosmetic reasons).  
Patients who do not complete the duration of treatment of negative 
pressure wound therapy (7 days), or patients who do not follow up for a 
minimum of 30 days from the date of surgery will be excluded.  Adults 
unable to consent, infants, children, teenagers, pregnant patients and 
prisoners will be excluded.  It is also extremely unlikely, based on our 
study population, that we will encounter any of these patients. 
 
6) 
Number of Subjects 
We would ideally like to enroll 30 subjects.  Data evaluation will begin 
after 10 subjects have enrolled and met inclusion criteria. 
7) 
Recruitment Methods 
 
All subjects will be patients of Dr. Michael Wong, and he will be the only attending 
surgeon of record for this study.  Subjects will be asked by the principal 
investigators (Wong or Bailey) if they would like more information about the study 
during their preoperative visit.  If they are interested, after they have qualified for 
panniculectomy in preparation for renal transplantation, the study can be discussed 
with them at their initial clinic visit, or they may elect to receive a phone call at a 
later time.  No patients will be formally recruited outside of the preoperative 
discussion.  There are no materials (paper or otherwise) that will be used to help 
recruit patients.  No advertisements will be used.  Identification of subjects will 
require access to personal health information without HIPAA authorization in that 
every patient who qualifies for a panniculectomy in preparation for renal 
transplantation qualifies. 
 
8) 
Compensation to the Subjects 
 
Subjects will not be compensated for this study 
 
9) 
Study Timelines 
The duration of an individual subject’s participation will be at a minimum 
of 30 days from the date of surgery or from the date of their last related 
operation (additional operations required as a result of their 
panniculectomy).  The duration of their inclusion in the study should be a 
maximum of 10 years to allow for adequate follow up, and to include 
wound healing after possible renal transplantation.  The duration 
anticipated for enrollment will be up to 6 years.  The estimated date of 
completion of the study will be July 2021. 
10) Study Endpoints 
Primary endpoints:  Wound healing complications (separation, abscess, 
hematoma, seroma, cellulitis) 

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Secondary endpoints: Drainage of hematoma, seroma or abscess. 
Tertiary endpoints:  Scar (Vancouver Scar Scale), pain (visual analog 
scale, narcotic use), quality of life (SF-36).   
11) Procedures Involved 
We propose a prospective trial be performed where patients who are 
already selected to undergo panniculectomy in preparation for renal 
transplantation (who are inherently at high risk for developing wound 
healing complications) be treated with incisional negative pressure 
wound therapy in an effort to evaluate the effect of negative pressure 
wound therapy on wound healing complications.  Patients will be 
randomized to participate after the patient qualifies for panniculectomy 
in preparation for renal transplantation.  The surgeon will not be made 
aware of thtee randomization until after standard wound closure is 
performed.  If a patient enrolls and is placed in the control group, they 
will receive standard of care operative incision treatment 
(dermabond/topical skin adhesive) after standard closure.  If a patient is 
enrolled in the incisional negative pressure wound therapy arm, they will 
receive standard wound closure and incisional negative pressure wound 
therapy overlying.  This device is placed on the wound, sterilely, in the 
operating room, to conclude the procedure.  The incisional negative 
pressure wound therapy device is to remain in place for 7 days, and will 
be removed in clinic after completion.  This device is the equivalent of 
an operative dressing, and is removed in the same fashion as any other 
dressing.  If there are overt signs of wound healing complications, 
incisional negative pressure wound therapy will be discontinued 
immediately and the patient will be treated according to standard of care.  
If the patient removes the incisional negative pressure wound therapy 
device, either purposefully or accidentally, they will be switched to 
standard of care dressings.  The incisional negative pressure wound 
therapy device will not be replaced on a wound for any reason, as the 
wound, once exposed after the operation, is rendered contaminated. 
For the purposes of this study, the FDA approved PICO (Smith & 
Nephew) incisional negative pressure wound therapy will be used for all 
patients in the INPWT arm. 
Data collection will be solely through EMR.  The SF-36 (Short Form 
Health Survey) will be used to evaluate patient’s quality of life during 
and after treatment with INPWT.  All mailed forms to be filled out will 
include self addressed envelopes. 
Baseline characteristics to be collected will include age, gender, race, 
BMI, diabetes, smoking status, renal failure cause, hypertension, 
pulmonary disease, vascular disease, prior abdominal operations, prior 
lower abdominal incisions, prior cesarean sections.  Postoperative/long 
term follow up data to be collected will include wound healing 
characteristics including complications, additional antibiotic 

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administration, narcotic use, time to drain removal, scar quality 
(Vancouver Scar Scale), quality of life (SF-36), length of 
hospitalization, number of subsequent hospital visits, number of 
procedures related to postoperative wound management, and 30 day 
mortality of any cause. 
No blood will be drawn for this study. 
12) Data and Specimen Banking 
No data or specimens will be banked for this study. 
13) Data Management and Confidentiality 
The association between patient with and without INPWT and 
postoperative complications will be evaluate overall and in subgroup 
analyses using univariate regression analysis.  Means and standard 
deviations will be used to summarize continuous variables.   Frequencies 
and proportions will be used to present the categorical clinical 
characteristics.  Fisher’s exact test will be used to test associations 
between complications and categorical variables.  Univariate and 
multivariate logistic regression models will be used to analyze 
associations between complications and INPWT use.  Univariate analysis 
will be used to evaluate the association between complications and other 
potential predictive factors (sex, age, BMI, smoking status, earlier 
abdominal surgery).  A stepwise model selection method will be used to 
fit a multivariate logistic regression model after identifying variables by 
univariate logistic regression.  A post-hoc power analysis will be 
performed. 
 
Each patient included in the retrospective review will receive a study number.  
One key linking the patient medical record number to the study number will 
exist, and will be secured within the department of Transplant Surgery at the 
University of California, Davis.  The key will only be available to the principal 
investigator, and will be terminated at the conclusion of the study. An electronic 
database will be generated from the patients’ study number, age, and the data 
sets. The database will not contain patient identifiers such as name, address, 
dates, phone numbers, fax numbers, e-mail addresses, social security numbers, 
medical record numbers, health plan beneficiaries, biometric identifiers, or 
photographs.  The proposed construct of our database nearly entirely de-
identifies the protected health information with the exception of age.   We 
recognize patient age is a potential identifier.  However, the patients’ ages may 
be a significant risk factor for wound complications, and thus will be included 
within the study.  We will protect this information by only granting access to the 
study personnel listed above and maintaining the database on a single computer 
dedicated to this research study. We will not allow reproduction of the database.  
Protected health information will not be re-used or disclosed to any other person 

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or entity, except as required by law or for authorized oversight of the research 
project. 
 
14) Provisions to Monitor the Data to Ensure the Safety of Subjects 
This study involves no more than minimal risk to the subjects. 
 
15) Withdrawal of Subjects 
There are no anticipated circumstances where a patient will be withdrawn 
from the study.  If a patient requests to have the INPWT device removed 
prior to completing 7 days of treatment postoperatively, the device will be 
removed and they will receive standard of care postoperative wound care 
and follow up.  Purposeful or accidental discontinuation of the INPWT 
device by the patient prior to completing 7 days of treatment will not 
preclude the patient from continuing to participate in this study, as 
inclusion of their data will still be important to our study.  Purposeful 
reason for discontinuation of the INPWT device does not include 
intentional removal by or at the direction of the physician or medical 
provider for any reason, as, again, these patient’s data is still important for 
evaluation in our study.  If a subject discontinues INPWT for any reason 
prior to completing 7 days of treatment, they will continue to receive 
standard postoperative care (wound care and follow up). 
16) Risks to Subjects 
Risks to the subjects are no more than minimal.  The device works 
identically to a postoperative dressing, save for a small canister than can 
fit in the palm of a hand.  This canister has previously been reported as 
either a non-issue or a minor nuisance by most patients.  This is in contrast 
to requiring patients to perform standard of care dressing changes at home 
for soaking, which increases the risk of periwound irritation and/or 
blistering.  Patients may also shower by removing the canister (electrical 
device), and replacing after. 
There are no currently unforeseeable risks.  There are no risks to an 
embryo or fetus should the subject be or become pregnant.  There are no 
foreseen risks to others who are not subjects (i.e. health care providers, 
partners, family members, friends). 
17) Potential Benefits to Subjects 
Previous studies have demonstrated the likely benefit of incisional 
negative pressure wound therapy on high risk wounds (Conde-Green, et al. 
Ann Plast Surg.  2013 Oct;71(4):394-7.  Stanard JP, et al.  Ostomy Wound 
Manage.  2009 Aug 1;55(8):58-66. Atkins BZ, et al.  Surg Innov.  2009 
Jun;16(2):140-6).  Specifically, the decreased rate of wound healing 
complications leading to expedited recovery, decreased use of antibiotics, 
decreased re-operation rate and possible improved scarring. 

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18) Vulnerable Populations 
Pregnant women, prisoners, neonates, children and impaired adults are inherently 
not renal transplant candidates and will not be encountered in this study. 
 
19) Multi-Site Research 
NA 
 
20) Community-Based Participatory Research 
NA 
 
21) Sharing of Results with Subjects 
Relevant findings critical to the patient’s future care will be shared via 
secure messaging (through EMR or through confidential transmission) to 
the patient’s primary care provider.  The results of the study will be made 
available to all physicians via literature publication at the conclusion of 
the study, however, no efforts will be made to individually communicate 
the results of the study to all participants, as contact information is 
frequently not adequately updated, sometimes unavailable and in 
situations where patients may be deceased. 
22) Setting 
All research will be conducted at the University of California, Davis 
Medical Center (Sacramento, CA).  Patients will be recruited during their 
preoperative visit after they have been selected to undergo panniculectomy 
in preparation for renal transplantation.  The application of the wound vac 
will occur in the operating room under sterile conditions after standard 
closure, concluding the operation.  There is no necessary involvement by a 
community advisory board.  
23) Resources Available 
Research Coordinator (TBD):  responsible for randomization of patients, 
ensuring device availability when applicable, will be available as an 
additional vector for postoperative communication with patients, will be 
jointly responsible for maintaining a prospective database regarding 
previously mentioned patient variables and outcomes. 
Research Assistant (TBD):  Will aid in data collection and evaluation, 
study design, manuscript production and editing. 
Co-investigator (Chad M. Bailey, MD. Resident Physician): Responsible 
for study design, data collection and evaluation, manuscript production, 
editing and submission, and future presentations, if applicable.  He will 
also be responsible for the supervision of the research coordinator and 
assistant(s).  Dr. Bailey is an integrated plastic surgery resident at the 
University of California, Davis Medical Center, and has previously 
published the UC Davis experience in performing panniculectomy in 

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preparation for renal transplantation (please see prior reference).  He has 
also served as the research assistant on two previous publications, on both 
of which he was responsible for confidential and secure data acquisition 
and evaluation. 
Investigator (Michael S. Wong, MD.  Professor of Surgery):  Responsible 
for study design, data collection and evaluation, manuscript production, 
editing and submission.  Will also be responsible for the supervision of the 
research coordinator and assistant(s).  Dr. Wong is a Professor of Surgery 
in the Division of Plastic Surgery at UC Davis Medical Center, the Plastic 
Surgery Residency Program Director, and has published numerous 
manuscripts in the field of plastic surgery.  He is also an active member of 
the American Association of Plastic Surgeons, the American College of 
Surgeons, the American Medical Association, the American Society for 
Reconstructive Microsurgery, the American Society of Plastic Surgeons, 
the California Society of Plastic Surgeons, and the University of 
California, Davis Surgical Society.  He is the only surgeon at UC Davis to 
have performed panniculectomy in preparation for renal transplantation. 
There is not expected to be any difficulty or shortfall in recruiting an 
adequate number of subjects during our proposed study time.  Time 
devoted to conducting research during our allotted study period should 
average 1-2 hours per week.  Facilities will be the UC Davis Plastic 
Surgery Clinics and Operating Rooms.  Additional medical or 
psychological resources are very unlikely to be necessary as a result of this 
study. 
All persons assisting with the research will attend a presentation 
explaining the study and the rationale for the study as well as an 
explanation of their role within the project.  Furthermore, they will be 
required to complete online UC Davis HIPAA training and briefed again 
in regards to the appropriate handling of patient information. 
24) Prior Approvals 
This study has not been previously reviewed. 
25) Provisions to Protect the Privacy Interests of Subjects 
Subjects privacy interests and personal information will be protected 
through standard HIPAA practices, including reporting of confidential 
information only to the patient.  Patients will have access to the Plastic 
Surgery clinic and research coordinator as well as on call Plastic Surgery 
staff unconditionally throughout the perioperative period, including, but 
not limited to, the period of time while the negative pressure wound 
therapy device is in place.  Patients will be examined in accordance to our 
surgery clinic policy and with a chaperone when necessary.  Only the 
research team and those providing direct care to the patient are permitted 
to access sources information about the subjects. 

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26) Compensation for Research-Related Injury 
Patients will not be compensated 
27) Economic Burden to Subjects 
There is no obvious economic burden to patients participating in this 
study. 
28) Consent Process 
Patients will be approached about the study either at their preoperative 
clinic evaluation or by phone after their clinic evaluation, prior to their 
operation. Patients will be allowed to wait until the day of surgery to 
consent.  Because of the short study period (7 days) there will be no 
process necessary to ensure ongoing consent.  We will be following HRP-
090. 
Languages other than English that patient’s may speak are numerous (e.g. 
Spanish, Mandarin, Tagalog, Japanese, etc).  Consent will be obtained 
using a UC Davis approved interpreter in person.  The written consent will 
be translated into the patient’s language of preference by interpretive 
services.  If the patient cannot achieve sufficient understanding of the 
study through the help of an interpreter, the patient will be excluded from 
the study. 
No patients under the age of 18 years old will be included in the study. 
Cognitively impaired adults are not candidates for renal transplantation 
and will not be encountered or included in this study.  Also patients who 
cannot provide consent are not candidates for renal transplantation and 
will not be included in this study. 
We will not be requesting a waiver of consent for this study. 
29) Process to Document Consent in Writing 
We will be following HRP-091.  Please see attached document HRP-502.  
Our research presents no more than minimal risk of harm to subjects but 
does involve procedures (incisional negative pressure wound therapy 
dressing placement at the end of planned panniculectomy). 
30) Drugs or Devices 
PICO negative pressure incisional wound therapy is an FDA approved 
device already stored in the Pavilion operating room.  The device comes 
sterilized, and there is no special handling of the device necessary beyond 
standard sterile technique.  If the patient has been randomized into the 
study group, preoperative planning will include the assurance that the 
device is available for use prior to the operation.  The operation is 
performed by a single surgeon at our institution, and thus will only be used 
by an authorized investigator.