Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center?
Phase: NA
Conditions: Obesity, Surgical Site Infections, Wound Complications, Complications; Cesarean Section
Sponsor: Tufts Medical Center

 
 
 
 
 
 
Study Title: A Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound 
Complications in Women with a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center? 
 
 
 
NCT02799667 
 
 
Version date:  04/08/2019 
 
 

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TUFTS MEDICAL CENTER/TUFTS UNIVERSITY RESEARCH PROTOCOL  
 
Version date:  04/08/2019 
Principal Investigator: Michael House, MD    
Study Title: A Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound 
Complications in Women with a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center? 
 
I. 
Aim and Hypotheses 
 
We aim to show that single use negative pressure dressings can decrease the rate of wound complications in 
obese women (BMI >40 kg/m2) undergoing cesarean deliveries at Tufts Medical Center. 
 
II. 
Background and Rationale 
 
A. Background:  
Obesity, defined as a BMI >30 kg/m2, is a growing epidemic in the United States, affecting 35% of the adult 
population. Reproductive aged women, 20 to 39 years old, are no exception, with obesity estimated at 31.9% of 
women in this age group(1). At the same time, the rate of cesarean delivery and infectious morbidity is 
increased in the obese population(2, 3) and maternal obesity increases the risk of post operative wound 
complications in women undergoing cesarean delivery(4). With cesarean delivery being the most common 
major operation in the United States, surgical site infections (SSIs) in obese women undergoing cesarean 
delivery is a growing problem that plagues the health care system and patients. Surgical site infections are the 
largest cause of nosocomial infections, implicated in 38% of all nosocomial infections. The CDC has defined a 
SSI as an infection related to an operative procedure that occurs at or near the surgical incision within 30 days 
of the procedure and further classifies SSIs as superficial incisional, deep incisional, or organ/space SSIs(5). At 
Tufts Medical Center, approximately 16% of the obstetric population has a BMI >40 kg/m2 when they present 
to labor and delivery and this percentage is even higher in women undergoing cesarean delivery. It has been 
shown in a secondary cohort of a randomized controlled trial that women with extreme obesity, BMI > 45 
kg/m2, have a twofold to fourfold increase in postoperative complications, which includes a 18.8% risk of 
wound complications(6). Another retrospective cohort study showed that obese women with a BMI >50 kg/m2 
have a 1 in 3 risk of a wound complication(7). A retrospective cohort study of obesity and post cesarean wound 
complications showed that there was a dose response relationship between obesity and post cesarean wound 
complications(8). The causes of SSIs and wound complications are multifactorial, however body mass index 
plays a large role.  Interventions to decrease wound complications in the obese population is an important area 
of interest with the potential to have a significant impact on post-operative care in obstetrics. In addition to the 
significant cost of additional treatments and hospital re-admissions, wound complications can cause significant 
personal distress and interfere with maternal/child bonding.  
 
Cohort studies in obstetrics have suggested that single use negative pressure dressings can decrease the 
risk of SSIs(9). However, at this point there is a paucity of randomized controlled trials that offer definitive 
evidence to support this additional expense. The PICO Single Use Negative Pressure Wound Therapy System 
by Smith and Nephew is a 4 X 11¾ inch dressing attached to a small pump that can deliver a negative pressure 
of –80 mm Hg5 and remain in place for up to 7 days.  This dressing also comes in larger sizes. A light indicator 
gives a green light if vacuum pressure is appropriately applied or a yellow light if there is an inadequate seal. A 
recent pilot study, a retrospective cohort study in women with a BMI >45 kg/m2 who underwent a cesarean 
delivery, found that single use negative pressure dressing reduced the rate of wound complications, 10.4% in 
the control group, and 0% in the study group, p=0.15(10). While this study was underpowered and did not 
achieve statistical significance, it does provide initial evidence that this device could be a benefit in this 
population.  Single use negative pressure dressings have been well utilized in surgical fields outside of 

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obstetrics, and have been shown to decrease the rate of surgical site infections(11). A retrospective study in 
patients undergoing open colectomies, and open abdominal procedure not unlike a cesarean, showed a decrease 
in surgical site infections in a multivariate logistic regression, OR 0.32, p<0.05, when single use negative 
dressings were employed(12). 
 
B. Rationale:   
Obese women undergoing cesarean deliveries are at increased risk for post-operative wound complications. A 
single use negative pressure dressing is a non-invasive safe device that may decrease this risk. Prior to initiating 
widespread use of this dressing, which adds additional expense to a cesarean delivery, it is prudent to prove that 
the intervention does decrease post operative wound complications. PICO Single Use Negative Pressure Wound 
Therapy (NPWT) is available at Tufts Medical Center, is FDA approved, and currently in use on Labor and 
Delivery. Currently, at the discretion of the attending physician, a PICO NPWT can be placed over the incision 
of women hypothesized to be high risk for a wound infection. At this time there is not definitive evidence to 
support this practice. 
 
 
 
III. Research Plan   
 
A. Experimental design: Randomized Controlled Trial  
B. Sample size and statistical analysis(es):  
Sample Size: At this time the wound complication rate at Tufts Medical Center is difficult to determine as not 
all complications are identified during the delivery admission and often complications are often diagnosed as an 
outpatient.  However based on experience, the wound complication rate in patient with class III obesity 
approximates 30% at Tufts Medical Center.  Based on sample size calculations, 242 subjects need to be 
randomized, with 121 in each study arm, to detect a statistically significant change in wound outcome between 
the study arms. A study of this size would have 80% power to detect a difference between treatment groups in 
the risk of wound complication from 30% to15%. The sample size calculations assume two-tailed tests with 
alpha=0.05.   The cesarean delivery rate at Tufts MC is approximately 30%.  Patients are recruited and sign 
informed consent for this study when they are admitted to the Labor and Delivery at Tufts Medical center.  This 
may be prior to knowing if they will undergo a cesarean section or if they will deliver during this hospital 
admission.  If 30% of patients with a BMI > 40 kg/m2 have a cesarean delivery, and not all patients deliver 
during their hospital admission, then approximately 1,000 patients need to be enrolled and consented in order to 
randomize 242 subjects.  It is possible that additional subjects will need to be recruited if more patients decline 
participation in the study, do not undergo cesarean, or are discharged prior to delivery than estimated.   
The rate of wound morbidity in the obese population has been reported to span a large range.  One study 
showed that wound morbidity in the obese population was noted to be 47.5% in obese women with a vertical 
skin incision(13).  Patients in this study can have either a Pfannenstiel or vertical skin incision depending on the 
clinical scenario. We based our definition of a wound complication on the CDC’c criteria for surgical site 
infection (SSI), which encompasses superficial, deep, and organ space SSIs, as well as additional complications 
such as skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma 
requiring evacuation, wound debridement, hospital re-admission, and additional operating room management. 
These wound complications will be included as outcome variables.  Superficial skin infections are defined as 
incisions with purulent drainage, organisms isolated from aseptically obtained culture or fluid, pain, tenderness, 
localized swelling, redness, or the incision is deliberately opened by surgeon, or the diagnosis of a superficial 
SSI diagnosed by a surgeon or attending physician.  Deep incisional SSIs include purulent drainage from the 
deep incision but not organ space, a dehiscence or deliberate opening of the deep incision due to fever, localized 
pain, or tenderness, an abscess of the deep incisional space, or the diagnosis of a deep incisional SSI by a 

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surgeon or attending physician. Lastly, organ/space SSIs involves purulent drainage, isolated aseptically 
obtained organisms, or an abscess in another part of the anatomy that was opened during the original surgery.   
 
Statistical Analysis: The composite outcome of interest (development of any wound complications) by 6 weeks 
will be tested using a Kaplan Meier survival analysis with intention to treat analysis. Demographic and clinical 
variables will be compared between the two groups to check for balance. If it found that confounders are 
imbalanced between groups, a Cox regression model will be performed to adjust for those variables. In addition, 
if patients do not receive the treatment they were randomized to, a secondary analysis will be performed 
analyzing patients as they were treated. 
All attempts will be made to minimize loss-to-follow-up, and reasons for any missing data will be 
tabulated. Procedures to prevent missing data are described in detail below. Given the risk of missing data, a 
Kaplan Meier survival analysis will be used to minimize the impact of loss to follow up.  A time-to-event 
analysis will be performed instead to account for censored data, and information from the last known visit will 
be used. Such a model would also account for demographic and clinical confounders. 
In addition to evaluating the primary composite outcome of wound complication, superficial, deep, and 
organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, 
hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room 
management secondary analyses will be performed. For secondary analyses, each complication outcome will be 
analyzed independently, as well as second composite outcome of major complications, including deep 
incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound 
debridement, hospital readmission and additional operating room management.  The outcome variables are 
similar to those used in previous studies (9).  
 
C. Subject Characteristics 
1. Subject criteria: Women presenting for care at Labor and Delivery at Tufts Medical Center with 
a BMI >40 kg/m2 will be approached to participate in this study.  BMI will be determined from 
their weight measurement at their last obstetric visit or if not available, their reported weight at 
the time of admission will be used.   
 
a) Inclusion criteria: BMI >40 kg/m2 undergoing cesarean delivery for any cause and willing to 
have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.  
b) Exclusion criteria: Exclusion criteria for this study is limited as we aim to make this study as 
generalizable as possible to the obstetric population.  Women less than age 18, women with 
an active infection in the location of Pfannenstiel skin incision, women not willing to come to 
Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not 
have height and weight information available, and women with a BMI < 40 kg/m2 will be 
excluded from this study.   
c) Withdrawal/Termination criteria: Patient request  
 
D. Risk/benefit assessment: Patients will be followed and assessed for the primary outcome of wound 
complications, which can include superficial, deep, and organ space SSIs, skin blisters around 
incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, 
wound debridement, hospital readmission and additional operating room management.  
 
1. Physical risk: The PICO NPWT is already in use in the high risk obstetric population at 
Tufts Medical Center. There is the risk that the patient will experience skin irritation 
associated with the adhesive on either the PICO NPWT or the standard dressing. An 
increased risk of adverse events with PICO NPWT dressings have not been reported in the 
literature, however, there could be a delay in the diagnosis of superficial skin infections in 

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the PICO NPWT study arm as the incision is not inspected daily. Other signs of cellulitis, 
such as fever or abdominal tenderness, would not be masked by the dressing. This population 
is at significant risk at baseline for post-operative wound complications.  
 
 
2. Psychological risk: None 
 
 
3. Social risk:  There is the risk of loss of patient confidentiality.  
 
4. Economic risk: There is no cost to the patient associated with the use of this dressing at this 
time. This device is not charged to the patient separately from global cesarean charge at this 
time. 
 
5. Benefit of participating in the study: There are no direct benefits to the study participants. 
However it is possible that one study arm will have an improved wound outcome.   
 
 
E. Specific methods and techniques used throughout the study:  
1. Laboratory tests: none 
2. Study Procedures: Based on randomization, a standard dressing or the PICO Negative Pressure 
Wound Therapy are applied after skin closure.  
 
 
Protocol 
Enrollment 
All pregnant women admitted the labor floor at Tufts Medical Center with a BMI >40 kg/m2 and without 
the above mentioned exclusion criteria will be approached to participate in this study of standard dressing 
verses PICO NPWT in the event they undergo a cesarean delivery.  If patients present for a scheduled cesarean 
delivery, they will be asked to participate in this study when they are in the pre-operative area.  Women 
admitted for labor, or induction of labor will be asked to participate when they are on the labor floor, after they 
have been admitted and seen by medical teams, but before the decision to proceed with cesarean delivery is 
made.  Women admitted to the labor floor at Tufts Medical Center for other medical or obstetric indications will 
be asked to participate once admitted and medically stable, however before the decision to proceed with 
cesarean delivery is made.  If a patient needs time to decide on participation, she will be left with the informed 
consent and asked to notify her nurse if she would like to participate, and the nurse will notify the study team. 
Otherwise a member of the study team will approach the patient one more time to ask for participation.  If a 
patient receives prenatal care at Tufts Medical Center in the outpatient setting, and meets eligibility criteria for 
enrollment, the patient can be approached following a regularly scheduled clinic visit at the discretion of the 
outpatient clinician. If a patient is undergoing an emergent or urgent cesarean, and did not already consent to 
participate in the study, they will not be approached to participate.  Subjects must be willing to have a follow up 
wound evaluation at Tufts Medical Center approximately 2 weeks post operatively. Informed consent will be 
obtained by designated study personnel. Subjects, however, will be randomized to either study arm at the time 
of facial closure. The decision to proceed with cesarean delivery will be based on medical or obstetric 
indications, and not influenced by enrollment in the study. If the patient consents to be part of the study, then 
demographic information will be abstracted from the patient and the patient’s hospital chart. 
 
Procedure 
 
When in the operating room, the operative procedure will not deviate from normal operating room 
procedures. All women will receive standard surgical prophylaxis with cefazolin or in penicillin/cephalosporin 
allergic, standard weight based dosing of gentamycin and clindamycin. If a subject is diagnosed with 

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chorioamnionitis during labor, she will receive standard treatment antibiotics.  The actual antibiotic will depend 
on her allergies.  Sterile abdominal preparation will follow the standard labor floor protocol prior to the start of 
the case. The operative steps of the cesarean delivery would be routine and up to the discretion of the attending 
physician. After delivery of the fetus, again management will be up to the discretion of the surgical team. In our 
obstetric population, patients are not routinely on therapeutic anticoagulation at the time of delivery. In all but 
urgent/emergent cases, anticoagulation is held prior to surgery and during labor. Per usual practice, hemostasis 
in achieved prior to closing a patient’s abdomen at the time of a cesarean section. After fascial closure, the 
subcutaneous tissue is inspected, and electrocautery is utilized if necessary for hemostasis. The skin is only 
closed after the subcutaneous tissue is hemostatic.  If there was a surgical complication, such as increased 
bleeding or an unexpected injury, the attending surgeon would have the option of declining participation in the 
study.  If this occurred, the patient would not be randomized to either study arm.  Study investigators will keep 
track of patients that consent to the study, undergo a cesarean delivery, and are not randomized. 
 
Randomization 
At the time of fascial closure, participants will be randomized to receive either the standard dressing or 
the PICO NPWT using a previously developed randomization schema based on randomly permuted blocks of 4, 
6, and 8. These envelopes will be created by personnel that are not involved with enrolling or randomizing 
patients. At the time of randomization in the operating room a sealed numbered envelope will be opened in 
numerical order, and the assignment group will be read out loud. Currently at Tufts Medical Center, the usual 
post cesarean section dressing consists of a non-adherent sterile gauze and sterile gauze covered with 
waterproof transparent bandages. After randomization, the specified dressing (standard vs PICO NPWT) will 
then be assembled by the operating room staff. The subcutaneous layer will be reapproximated if greater than 2 
cm in depth, per normal protocol.  The skin will be closed with suture or staples at the discretion of the surgical 
team. At the end of the procedure, the pre-determined dressing will be placed by the resident and scrub 
technician. The PICO NPWT dressing comes with a small pump, two dressings, and fixation strips, and the 
extra dressing and fixation strips will remain with the patient. 
 
Post-Operative Care 

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All subjects will have a post-operative check approximately 4 hours after their cesarean delivery. This is 
routine and not a deviation from normal clinical practice. At that time the patient’s vitals will be reviewed and 
they will be examined.  The physical exam includes an inspection of the surgical dressing. Routinely, areas of 
blood saturation on the dressings are noted, and if this is abnormal, the dressing would be removed, hemostasis 
achieved, and the appropriate dressing re-applied.   
During the post-operative period all patients will receive routine post-operative care with discharge 
home on post operative day 4 if their post operative course is uncomplicated. Per routine, patients randomized 
to the standard dressing will keep their dressing in place for 12 to 48 hours post operatively, with a wound 
evaluation daily as part of their daily physical exam. Patients randomized to the PICO NPWT arm will also be 
evaluated daily, however their dressing will be in place until the day of discharge or until the indicator light on 
the pump signals that there is no longer an adequate seal and the dressing needs to be changed. The skin area 
around the dressing will be evaluated daily. The PICO NPWT dressing will be removed, the incision inspected, 
and a new PICO NPWT dressing replaced either on the day of discharge, or when the indicator on the pump 
changes from green to orange. The dressing can be removed by the patient at home after 7 days of total use, or 
sooner if the pump indicator changes from green to orange indicating that the pump no longer is maintaining a 
seal.  If the patient received staples for skin closure and had a Pfannenstiel skin incision, then the staples can be 
removed and steri strips applied on post operative day 3 or 4, which corresponds to when the PICO NPWT 
dressing is replaced.  It is normal obstetric practice to remove stables in a Pfannenstiel skin incision on post 
operative day 3 or 4. If the patient had a vertical skin incision closed with staples, staples are normally removed 
between post operative days 7 and 10. This would require an additional outpatient visit.  
At any time during the post operative course a patient will be treated with antibiotics if there is the 
clinical suspicion for a wound infection or if the patient has a febrile illness concerning for infection. Medical 
management of a post operative complication will not be altered due to participation in this study. If a patient in 
the PICO arm becomes febrile (>100.4), the PICO dressing will be removed and the wound evaluated, however 
the dressing can be replaced if there is no evidence of a wound complication.   
The most serious complications include hospital readmission and additional operating room 
management. These complications are rare, and the decision to proceed with these steps would be up to the 
patient’s physician. While the study is not blinded to randomization arm, physicians will be independently 
evaluating their patients and basing further treatment on their best clinical judgment.  
 
Follow-Up  
After discharge from Tufts Medical Center, all patients will be scheduled for a follow up wound 
evaluation approximately two weeks post operatively in the ambulatory clinic at Tufts Medical Center, which is 
common practice among patients at high risk for wound complications. To minimize loss to follow up, patients 
will be called to remind them of their 2 week follow up appointment 24-48 hours prior to their appointment and 
they will be asked a series of questions about their incision at that time. If they are not able to be reached, then 
additional attempts will be made to reach them.  If they miss their 2 week wound evaluation, they will be called 
to reschedule.  At this visit the surgical incision will be evaluated by members of the wound team, MFM 
fellows and MFM attendings, who have been trained in a standardized way to evaluate the incision.  Wound 
management, if complications arise, will be at the discretion of the evaluating physician. Patients will follow up 
at 6 weeks post partum at Tufts Medical Center, Tufts satellites, or their primary obstetrician’s office.  Given 
that not all patients will present to Tufts Medical Center for a 6 week follow up visit, all patients will be called 
at approximately 6 weeks post partum and asked standardized questions about their surgical incisions and 
possible complications. If they are not reached, additional attempts will be made to contact the subject.  
 
Outcome Measurement 
The primary outcome will be a composite outcome of wound complications, which includes superficial 
skin infection requiring antibiotics (cellulitis), skin blisters around incision, scar separation > 1 cm, seroma 
requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional 

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operating room management. This composite outcome is similar to the primary outcome in a recent historical 
cohort looking at NPWT and post-operative complications (9). 
The primary outcome will be considered positive if any of the composite items were diagnosed in the 
period between delivery and 6 weeks post-partum. The outcome is the variable of interest; the time within the 6 
week post-partum period that the outcome occurred is not critical in this study. The medical records from the 
hospitalization, wound check at 2 weeks post-partum, and information from the phone calls at 2 and 6 weeks 
post partum will be reviewed and if the patient was positive for any of the mentioned outcomes then that would 
be considered an event. Specifically, all the daily progress notes from hospital admission, discharge medications 
(antibiotics), and hospital discharge summary will be evaluated.  On the day of discharge, the discharging team 
(resident and attending) will complete a specific “Incision Note” in OBTRACEVUE, the electronic medical 
record system used for all inpatient obstetric patients. This “Incision Note” will be a template and allow the 
residents to answer basic questions pertaining to post-operative fevers, additional antibiotics given during the 
post-operative period, and diagnoses of cellulitis, skin blisters, scar separation, seroma requiring evacuation, 
hematoma requiring evacuation, wound debridement, and additional operating room management. This note 
will be completed by the residents and signed by the discharging attending. The “Incision Note” completed by 
the residents on the day of discharge will help to standardize outcomes.  If the residents do not complete this 
note, the data will be abstracted from the medical records.  
After the 2 week post operative follow up visit with a member of the wound team, the evaluating 
physician will fill out a short wound evaluation form, and the outpatient notes will be reviewed in detail, 
specifically the HPI, physical exam where the incision is described, and assessment/plan portion of the notes. If 
antibiotics are prescribed or further treatment is needed it would be noted in the medical records and on the 
short evaluation form. If there is a wound complication, it would be described in detail, with measurements and 
treatment if applicable. Members of the wound team will be trained to standardize their evaluation.  Due to 
patient scheduling needs, it is possible that the patient could be seen outside of their anticipated visits, and these 
notes will be reviewed as well and any of the components of the composite outcome will count as an event.   
All patients will be called on the telephone 24 to 48 hours prior to their approximately 2 week post-
partum visit to remind them of their scheduled appointment. If they do not attend this appointment, they will be 
called to reschedule and at that time they will be asked if they had any of the composite outcomes and these 
results will be recorded.  They will be called at 6 weeks post partum and at this time, they will be asked if they 
had any of the composite outcomes and these results will be recorded. The course of follow-up (6 weeks) is 
stated in the informed consent process. The assessment period will conclude at their final post-partum phone 
call, approximately 6 weeks post-partum. To standardize the results, the initial hospitalization, 2 week post 
partum wound evaluation and phone call, and the 6 week post partum phone call will be used to obtain the 
outcomes.  Due to the complexity of the lives of these patients, it is possible that a patient will not present 
precisely at the 2 week wound evaluation, however any visit within that time period with a member of the 
wound team will be adequate to assess for wound complications.  The above described phone calls at 2 and 6 
weeks post-partum will aid in assessing outcomes if the patients do not present for their appointments.  
 
3. Subject Timeline: This study will run for two years, from the month is approved 2016 to 2018.    
 
F. Assessment of Subject Safety and Development of a Data and Safety Monitoring Plan 
 
1. Definition of Serious Adverse Event (SAE) and Adverse Event (AE) for this study: Wound 
complications, infection, and wound breakdown are anticipated in this population, obese women 
undergoing cesarean delivery.   A SAE would be a severe necrotizing infection such as 
necrotizing fasciitis.  Women with severe wound complications of febrile morbidity will be 
admitted to the hospital for further management.  While wound complications are anticipated in 
this population, the rate of severe adverse events is not expected to increase.  This is a small 
study, and a Data Safety and Monitoring Board is not necessary.  If SAEs occur, the evaluation 

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will be investigator initiated, and events will be reported to the IRB per the IRB’s Reportable 
New Information policy.     
2. Reporting timeframe for SAEs and AEs: SAEs and AEs will be reported to the Tufts 
MC/TUHS IRB per the IRB’s Reportable New Information Policy. 
3. Accountability procedures as they relate to drugs, devices, and data:  Every effort will be made 
to keep a subject’s data confidential.  Data collected will be maintained on a password protected 
database in a locked office at Tufts MC.  Study data will be kept in a locked electronic database 
for 7 years after the completion of the study.  
 
G. Subject Participation 
 
1. Recruitment: Women will be recruited for this study when they are either (1) admitted to the 
labor floor at Tufts Medical Center if their BMI is > 40 kg/m2 or (2) during an office visit to the 
obstetrics and gynecology department at Tufts Medical Center for regular prenatal care at a date 
prior to their planned hospital admission  Subjects will be approached by members of the 
research team and asked to participate in the study on wound dressings if they undergo a 
cesarean delivery. The basis of the study will be explained, and the two possible dressings and 
the follow up will be described. Some patients who are enrolled in the study will not be 
randomized as not all patients will be delivered at Tufts Medical Center or undergo cesarean 
delivery.  
 
2. Registration: Patients will be designated a study participant when they sign the informed 
consent document.  Subjects will be randomized to either study arm at the time of facial closure 
when they undergo cesarean delivery.  Not all patients will be randomized or included in the 
analysis as not all patients who sign an informed consent will have a cesarean delivery.  
 
2. Screening Interview/questionnaire: not applicable  
 
3. Transportation: Patients will be seen at their regularly scheduled visits, no additional 
transportation is required. 
 
4. Informed consent process and timing of obtaining of consent: Informed consent will be 
obtained after either (1) admission to labor and delivery or (2) during an office visit to the 
obstetrics and gynecology department at Tufts Medical Center for regular prenatal care at a date 
prior to their planned hospital admission by an approved member of the research team.  The 
consent interview will take place in the subject’s private room at Tufts MC after the patient has 
been seen by the necessary medical teams.  When the patient is initially approached to participate 
in the study, the study will be explained and they will have the opportunity to ask any questions.  
We will explain that their participation in the study does not mean they will have a cesarean 
section, and that study participation will not change their medical care during their 
hospitalization.  We will discuss that even if the patient does not participate in the study, she may 
receive either of the two dressings, depending on the preference of the medical team.  We will 
discuss that their medical history, demographic information, and wound outcomes will be kept 
confidential on a locked computer.  Subjects will be asked if they understand the study and that it 
is voluntary.  Subjects will not be pressured to make a decision to participate, and while they will 
have the option of signing consent at the time of the initial interview, or if they would like more 
time, then a member of the research team will check in with the subject the next day. The subject 
can decide not to participate in the study at any time.  The persons obtaining informed consent 

Page 10 of 12 
 
are all medical doctors or research staff from the department of obstetrics and gynecology on the 
study team, however this person may also be the medical doctor in charge of the patient’s care.  
a. If non-English speaking persons will be enrolled, state the informed consent process for 
enrolling the subjects, including who will conduct the consent interview, use of 
interpreters, translated documents, etc.:  We do anticipate enrolling non-English speaking 
patients, if they fit our inclusion and exclusion criteria. For these patients, the Tufts Medical 
Center Short Form will be used per the Tufts IRB policy.  
6. Location where study will be performed: The study will be conducted at Tufts Medical Center, 
800 Washington Street, Boston MA 02111.  Records will be kept on a locked spreadsheet on a 
computer in a locked office at Tufts Medical Center.  The initial data collection sheet that is used 
to abstract demographic information and record operating room information will be used to input 
data into the spreadsheet and then stored in a locked office. 
 
7. Personnel who will conduct the study, including: 
a. Present during study procedure(s) and their proximity during the study: Ashley 
Peterson will be responsible for conducting the study, however, as the standard dressing and 
PICO NPWT are currently in use on labor and delivery, study personnel will not always be 
present during randomization and bandage placement. 
 
b. Primary responsibility for the following activities:  
 
i. Obtaining informed consent: Members of the study team obtaining informed consent 
include the following obstetricians: . The study is now closed to enrollment. Moving 
forward, no members of the study team will be obtaining informed consent from 
participants. 
 
ii. Providing on-going information to the study sponsor and the IRB: Ashley Peterson 
 
iii. Maintaining participant's research records: Ashley Peterson 
 
8. Subject fees: none 
 
9. Study results: Subjects will not be notified of results.  
 
10. Procedures to protect subject confidentiality: Patient data will be stored in a password 
protected spreadsheet on a computer in a locked office at Tufts Medical Center.  Physical papers 
used to abstract demographic information and operating room data will be stored in a locked 
office.   
 
11. Confidentiality: 
 
a. Certificate of Confidentiality: Not applicable 
 
b. How data will be coded, recorded, and stored to protect confidentiality: Data with 
patient demographic and operative information will be recorded on a paper form during 
the cesarean delivery, and placed in a locked box at the end of the case. Forms will be 
collected and inputted into a password protected data set which will on a Tufts Medical 
Center computer in a locked office and the forms will be stored in a locked office. 
Clinical data from the hospital admission, post operative visits, and phone calls will be 

Page 11 of 12 
 
recorded in the electronic medical record, which requires a username and password to 
access.  Data will be abstracted from the electronic medical record and inputted into the 
locked spreadsheet.  
 
c. Parties who will have access to the date, including the key to the identity code: 
Michael House, Ashley Peterson 
 
d. Parties who will have access to research records: Michael House, Ashley Peterson 
 
12. Collaboration: NA 
 
13. Alternatives:   If a patient does not participate in this study, then they could receive either the 
standard dressing or the PICO dressing at the end of their cesarean delivery.  
 
14. How new information will be conveyed to the study subject and how it will be documented: 
Not applicable 
 
15. Payment, including a prorated plan for payment: none 
 
16. Payment for a research-related injury: none 
 
I. Outcome: We expect to see a statistically significant difference in wound complications, specifically 
major complications, between the standard dressing and PICO dressing study arms. The endpoint 
will be when 242 patients are randomized to either study arm.  The study results will be reported in a 
peer reviewed journal after study completion.  
  
J. Tissue banking considerations: None 
 
VULNERABLE POPULATIONS: Pregnant patients. 
 
 
1. 
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. 
NCHS Data Brief. 2012(82):1-8. 
2. 
American College of O, Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. 
Obstetrics and gynecology. 2013;121(1):213-7. 
3. 
Myles TD, Gooch J, Santolaya J. Obesity as an independent risk factor for infectious morbidity in 
patients who undergo cesarean delivery. Obstetrics and gynecology. 2002;100(5 Pt 1):959-64. 
4. 
Mourad M, Silverstein M, Bender S, Melka S, Klauser CK, Gupta S, et al. The effect of maternal 
obesity on outcomes in patients undergoing tertiary or higher cesarean delivery. The journal of maternal-fetal & 
neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of 
Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstet. 2015;28(9):989-93. 
5. 
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site 
Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices 
Advisory Committee. Am J Infect Control. 1999;27(2):97-132; quiz 3-4; discussion 96. 
6. 
Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstetrics and 
gynecology. 2014;124(2 Pt 1):227-32. 
7. 
Alanis MC, Villers MS, Law TL, Steadman EM, Robinson CJ. Complications of cesarean delivery in 
the massively obese parturient. American journal of obstetrics and gynecology. 2010;203(3):271 e1-7. 
8. 
Conner SN, Verticchio JC, Tuuli MG, Odibo AO, Macones GA, Cahill AG. Maternal obesity and risk of 
postcesarean wound complications. Am J Perinatol. 2014;31(4):299-304. 

Page 12 of 12 
 
9. 
Swift SH, Zimmerman MB, Hardy-Fairbanks AJ. Effect of Single-Use Negative Pressure Wound 
Therapy on Postcesarean Infections and Wound Complications for High-Risk Patients. J Reprod Med. 
2015;60(5-6):211-8. 
10. 
Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications 
following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014;21(4):345-9. 
11. 
Scalise A, Calamita R, Tartaglione C, Pierangeli M, Bolletta E, Gioacchini M, et al. Improving wound 
healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional 
Negative Pressure Wound Therapy. A systematic review of the literature. Int Wound J. 2015. 
12. 
Bonds AM, Novick TK, Dietert JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound 
therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 
2013;56(12):1403-8. 
13.  
Thornburg LL, Linder MA, Durie DE, Walker B, Pressman EK, Glantz JC. Risk factors for wound 
complications in morbidly obese women undergoing primary cesarean delivery.  The Journal of Maternal-Fetal 
& Neonatal Medicine. 2012; 25 (9): 1544-1548 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 1 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
 
TUFTS MEDICAL CENTER 
TUFTS UNIVERSITY 
Obstetrics and Gynecology 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH  
 
A Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce 
Wound Complications in Women with a BMI > 40 kg/m2 Undergoing Cesarean Delivery at 
a Tertiary Medical Center?  
 
Principal Investigator:  Michael House, MD  
Co-Investigators:  Ashley Peterson , MD 
Study team telephone number: 617-636-2627 (Office) 978-970-2389 (Ashley Peterson’s Cell 
617-320-6128) 
 
INTRODUCTION 
 
You are being invited to take part in a research study involving how your cesarean wound 
incision will be covered immediately after delivery, if you have a cesarean delivery.  
Participating in this study does make you more or less likely to have a cesarean section.   If you 
have a cesarean, some women receive a standard bandage of tape and gauze that is placed over 
their incision.  This bandage is removed 1 or 2 days after surgery.  Some women are at high risk 
for wound complications. Sometimes a doctor decides to use a special bandage to help prevent 
wound complications. This bandage is attached to a small pump and is placed over the incision.  
The pump is turned on and this creates a suction (negative pressure) within the bandage.  This 
bandage can stay in place for 7 days. At this time, we do not know which bandage is better for 
our patients at high risk for wound complications.  We would like to randomize subjects to 
receive either the standard gauze and tape bandage or the negative pressure bandage and see 
which subjects do better.  
 
Taking part in this research study is entirely your choice. You can decline to participate in this 
study. If you decide to participate in this study, you can stop taking part in the study at any time 
for any reason. If you decline to participate in the study or stop being in this study, it will not 
affect your medical care, payment for your health care, or your health care benefits.  
 
Please read all of the following information carefully. Ask Dr. Peterson or Dr. House, or their 
representatives, to explain any words, terms, or sections that are unclear to you. Ask any 
questions that you have about this study.  Do not sign this consent form unless you understand 
the information in it and have had your questions answered to your satisfaction.   
 
If you decide to take part in this research study, you will be asked to sign this form. You will be 
given a copy of the signed form. You should keep your copy for your records. It has information, 
including important names and telephone numbers, to which you may wish to refer in the future. 
 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 2 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
New things might be learned during this study that you should know about. The investigators 
will tell you about new information that may affect your willingness to stay in this study.  
 
If you are eligible to participate and decide to be in the study, the Principal Investigator may still 
choose to stop your participation in this study if he thinks it is in your best medical interest.  You 
will not be included in the study if you have a cesarean delivery but are not randomized to either 
study arm while in the operating room.  
 
If you withdraw or are withdrawn from the study, any data collected from you before your 
withdrawal will still be used for the study. 
 
As a participant in this study, your identity, medical records, and data relating to this study will 
be kept confidential, except as required by law.  
 
If you have question about your rights as a research study subject, call the Tufts Medical Center 
and Tufts University Health Sciences Institutional Review Board (IRB) at (617) 636-7512. The 
IRB is a group of doctors, nurses, and non-medical people who review human research studies 
for safety and protection of people who take part in the studies. Federal law requires the IRB to 
review and approve any research study involving humans. This must be done before the study 
can begin. The study is also reviewed on a regular basis while it is in progress. 
 
This research study has been reviewed and approved by the IRB of Tufts Medical Center and 
Tufts University Health Sciences.   
 
PURPOSE OF STUDY 
 
The purpose of this study is to determine if a negative pressure dressing, called the PICO 
Negative Pressure Wound Therapy, will improve healing of a cesarean section wound in women 
with a BMI > 40 kg/m2.  The bandage is approved for use by the FDA (Food and Drug 
Administration).  The PICO bandage was previously studied in patients who are not pregnant.  
Our goal is to study healing with the PICO bandage after a cesarean section.  The PICO bandage 
is currently used on labor and delivery, however use of this dressing is not the standard of care. 
 
In some women, the cesarean section wound does not heal well.  The wound can open up or get 
infected.  Women who are obese are at increased risk for a wound complication.  In this study, 
our goal is compare the PICO bandage to the standard bandage for healing a cesarean section 
wound.  It is possible that the PICO bandage will reduce wound complications.  But it is also 
possible that the PICO bandage will have no effect or even increase wound complications.   
 
Normally, the standard of care at Tufts Medical Center, for subjects like you who would benefit 
equally from both the standard dressing or the PICO Negative Pressure Wound Therapy, would 
involve a conversation between the medical teams about the surgical dressing options.  The 
decision to choose either the standard dressing or the PICO Negative Pressure Wound Therapy 
may depend the personal preference of the doctor. Participating in this study is different from the 
standard of care because neither the patient nor the doctor gets to choose which dressing is used. 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 3 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
You will be randomly assigned to the standard dressing or the PICO Negative Pressure Wound 
Therapy.  
 
 
The study will be conducted at Tufts Medical Center, 800 Washington Street, Boston MA 02111, 
on Labor and Delivery.  1,000 subjects will be enrolled however not all of these subjects will 
undergo cesarean delivery. We plan to randomize 242 subjects.  
 
PROCEDURES TO BE FOLLOWED 
 
If you have a cesarean delivery and undergo randomization, you will have a 50% chance of 
getting a PICO bandage and 50% chance of getting a standard bandage to cover the wound.  The 
decision for the standard bandage or the PICO bandage will be made randomly, like a coin flip.  
Each of these bandages are applied after the skin is closed and the operating time will not be 
increased or decreased.  You will be evaluated every day during your hospitalization as you 
normally would.  To assess your wound outcome, your hospitalization records will be reviewed, 
as will notes from your post operative and post partum visits.  You will be seen at Tufts Medical 
Center 2 weeks after delivery for evaluation by a member of the wound team. You will receive a 
phone call to remind you about this appointment, and if you miss this appointment you will be 
called to reschedule.  You will receive phone calls and be asked a series of questions about your 
incision at both 2 and 6 weeks post partum. Per routine obstetric care, you will have a 6 week 
post partum visit.  For this visit you can follow up with an obstetrician at Tufts Medical Center 
or your primary obstetrician, and this may not be at Tufts Medical Center.  Six weeks after 
delivery is the usual period of time that women are followed after having a baby. If you have any 
additional concerns about your wound outside of these outlined appointments you can call the 
Maternal Fetal Medicine clinic at Tufts Medical Center (617-636-8917) and an appointment will 
be arranged.   
 
Even if you decide not to participate in the study, you could still receive either one of those 
bandages.  Your doctor would decide which bandage you receive.  
 
RISKS 
 
There are no additional physical risks associated with study participation.  All women 
undergoing cesarean delivery have the risk surgical site infections, seromas or hematomas 
requiring evaluation, skin blisters, scar separation, additional wound debridement, additional 
operating room management, or hospital readmission, among other surgical complications.  We 
would like to know if the risk of wound complication depends on the type of bandage you 
receive.  Since wound complications can occur after cesarean deliveries, women with either 
bandage will experience some of these complications.  
 
Additionally, loss of confidentiality is a risk of study participation. Data collected from this study 
will be stored on a locked spreadsheet on a computer in a locked office at Tufts Medical Center. 
Paper records will be stored in a locked office at Tufts MC.  
 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 4 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
 
 
BENEFITS 
While there are no direct benefits to you from participating in this study, you will contribute to 
the knowledge of post-operative wound care and women in the future may benefit from what is 
learned.  
 
ALTERNATIVES 
 
The alternative is to NOT participate in the research study.   Your medical care during your 
hospitalization will not change if you do not participate.  If you chose not to participate, then you 
could receive either the standard bandage or the PICO bandage depending on the preference of 
your attending surgeon.  
 
RESEARCH RELATED INJURY 
 
Emergency medical treatment will be given to you if you are hurt or get sick as a direct result of 
being in this research study. You or your insurance carrier will be required to pay for any such 
medical care. Any needed medical care is available at the usual cost. All needed facilities, 
emergency treatment, and professional services are available to you, just as they are to the 
general public. The institution will not pay for your treatment if you become ill or injured as part 
of this study.  
 
COSTS 
 
There are no costs associated with this study. At this time, the hospital does not bill patients 
separately for the bandage placed at the time of cesarean delivery. 
 
PAYMENT  
You will not be paid for participating in this study. 
 
PRIVACY AND CONFIDENTIALITY 
 
Medical information, including wound complications, will be stored in a password protected 
document on a Tufts MC computer in a locked office. Paper records will also be stored in a 
locked office at Tufts MC.  For analysis, data will be de-identified.   
 
If you agree to take part in this research study, your personal information will not be given to 
anyone unless we receive your permission in writing. It will only be given if the law requires it. 
It will also only be given for regular hospital treatment, payment, and hospital management 
activities.  
 
We will make every effort to keep your information private, but it cannot be completely 
guaranteed.   The Institutional Review Board of Tufts Medical Center and Tufts University 
Health Sciences may check records that identify you. This might include your medical or 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 5 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
research records and the informed consent form you signed. The records of this study might also 
be reviewed to make sure all rules and guidelines were followed. 
 
A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required 
by US 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. 
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH 
INFORMATION  
 
If you sign this document, you give permission to the Principal Investigator named above and 
research staff at Tufts Medical Center as well as other individuals at Tufts Medical Center who 
may need to access your information to do their jobs (such as for treatment, payment (billing) or 
health care operations) to use or disclose (release) your health information that identifies you for 
the research study described above.   
 
The parties listed in the preceding paragraph may disclose the health information described 
below to the following persons and organizations for their use in connection with the research 
study:  
• Individuals or organizations working under the direction of the Principal Investigator(s) 
for the study,  
• Outside individuals or entities that have a need to access this information to perform 
activities relating to the conduct of this research, such as analysis by outside laboratories 
on behalf of Tufts Medical Center.  
• The Office for Human Research Protections in the U.S. Department of Health and 
Human Services, the United States Food and Drug Administration (FDA) and other 
federal and state agencies that have the right to use the information as required by law, 
and 
• The members and staff of any Institutional Review Board (IRB) and Data and Safety 
Monitoring Board that oversee this study.  
 
The health information that we may use or disclose (release) for this research study includes all 
information in your medical record related to the diagnosis and management of your post-
operative course, including the record of your care, as well as any information collected or 
created during the course of this study. 
 
Tufts Medical Center is required by law to protect your health information. By signing this 
document, you authorize Tufts Medical Center to use and/or disclose (release) your health 
information for this research. Those persons who receive your health information may not be 
required by Federal privacy laws (such as the Privacy Rule) to protect it and may share your 
information with others without your permission, if permitted by laws governing them. You may 
not be allowed to see or copy the information described on this form as long as the research is in 
progress, but you have a right to see and copy the information upon completion of the research in 
accordance with hospital policies. 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 6 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
 
Tufts Medical Center may not withhold or refuse to provide you with clinical care based on 
whether or not you sign this form.  
 
This authorization does not have an expiration date. You may change your mind and revoke 
(take back) this authorization at any time. Even if you revoke this authorization, this site’s 
clinical, administrative and research staff may still use or disclose health information they 
already have obtained about you as necessary to maintain the integrity or reliability of the current 
research. To revoke this authorization, you must write to: HIPAA Privacy Officer for Research, 
800 Washington Street, Box 5100, Boston, MA 02111.  If you revoke this authorization, you 
may no longer be allowed to participate in the research described in this form.  
 
WHOM TO CONTACT 
 
Michael House, MD, mhouse@tuftsmedicalcenter.org,  617-306-6621  
Ashley Peterson, MD, apeterson@tuftsmedicalcenter.org, 617-320-6128 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Randomized Trial, Wound Dressing  
 
 
         
Michael House, MD 
ICF version:  4/04/2018 
Page 7 of 7 
Tufts Medical Center/TUHS IRB # 11943 
                                                                                                              Approved on 04/26/2018 
                                                                                                            Valid Until: 05/03/2019 
 
 
 
 
 
 
 
Documentation of Consent 
 
I have been given a copy of this form. I have read it or it has been read to me. I understand the 
information and have had my questions answered to my satisfaction. I agree to take part in this 
study.  
 
I understand that I will be informed of any new findings developed during the course of this 
research study that may affect my willingness to stay in this research study. 
 
 
_____________ 
 
 
_____________________________________________ 
Date 
 
 
 
 
Participant’s Signature 
 
I have fully explained to ________________________________ the nature and purpose of the 
above-described study and the risks that are involved in its performance.  I have answered all 
questions to the best of my ability. 
 
 
_____________ 
 
 
____________________________________________ 
Date 
 
 
 
 
Principal Investigator or Representative’s Signature 
 
 
 
_____________ 
______________________________ 
________________________ 
Date 
 
 
Witness’ Signature 
 
 
 
Witness Name