Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery
Phase: PHASE4
Conditions: Negative Pressure Wound Therapy, Cesarean Section; Infection
Sponsor: Indiana University

 
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Version 1.0: 15 November 2019 
 
 
 
STUDY NAME 
 
CLINICAL INVESTIGATION PLAN 
 
VERSION: 1.0 (11/15/19) 
 
CIP No.: HC#1902 
 
IU IRB #: 1910647251 
 
 
 
Study Title:  
Medela INVIA Motion NPWT system for prophylactic use on surgical incision after 
cesarean delivery 
 
 
 
 
 
 
 
 
 
 
Study Device 
Medela INVIA Motion 
 
 
Manufacturer 
Medela AG 
Lättichstrasse 4b, 
6340 Baar 
Switzerland 
 
 
 
PI contact 
Name: Methodius Tuuli, MD, MPH 
Title: Professor, Vice Chair for Obstetrics 
Phone: 678 558 2874 
Email: mtuuli@iu.edu 
 
 
 
 
REVISION HISTORY 
 
Version 
Date 
Summary 
1.0 
15 November 
2019 
Approved version for study initiation 
 
 
 
 
 
 

 
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Version 1.0: 15 November 2019 
 
Table of contents 
1 
SYNOPSIS ...................................................................................................................................... 4 
2 
CONTACT INFORMATION ........................................................................................................... 6 
3 
PARTICIPATING INSTITUTIONS ................................................................................................. 6 
4 
ABBREVIATIONS .......................................................................................................................... 6 
5 
INTRODUCTION ............................................................................................................................ 7 
6 
STUDY DEVICE(S) ........................................................................................................................ 7 
6.1 
STUDY DEVICE DESCRIPTION ................................................................................................................. 7 
6.2 
ACCESSORY(IES) DESCRIPTION ............................................................................................................. 8 
6.3 
STUDY DEVICE INTENDED USE ................................................................................................................ 8 
6.4 
PROCEDURE ......................................................................................................................................... 10 
6.5 
TRAINING REQUIREMENTS .................................................................................................................... 10 
6.6 
STUDY DEVICE MANAGEMENT .............................................................................................................. 10 
6.6.1 
Device complaints/malfunction of device ................................................................................ 10 
6.6.2 
Reporting of complaints ............................................................................................................ 10 
6.6.3 
Inventory and accountability records ....................................................................................... 10 
6.6.4 
Device storage ............................................................................................................................ 11 
6.6.5 
Device return ............................................................................................................................... 11 
7 
RISK ANALYSIS .......................................................................................................................... 11 
7.1 
RISKS .................................................................................................................................................... 11 
7.2 
BENEFITS .............................................................................................................................................. 11 
7.2.1 
Risk-to-benefit rationale ............................................................................................................ 11 
8 
INVESTIGATIONAL PLAN .......................................................................................................... 11 
8.1 
STUDY OBJECTIVES .............................................................................................................................. 11 
8.2 
STUDY HYPOTHESES ............................................................................................................................ 11 
8.3 
CLAIMS TO VERIFY ................................................................................................................................ 11 
8.4 
RISKS TO ASSESS ................................................................................................................................. 11 
8.5 
STUDY DESIGN ...................................................................................................................................... 12 
8.6 
PRIMARY ENDPOINT ............................................................................................................................. 12 
8.6.1 
Secondary endpoints ................................................................................................................. 12 
9 
SUBJECT SELECTION ............................................................................................................... 12 
9.1 
INCLUSION CRITERIA ............................................................................................................................. 12 
9.2 
EXCLUSION CRITERIA ........................................................................................................................... 12 
9.3 
WITHDRAWAL CRITERIA AND PROCEDURE ........................................................................................... 12 
9.4 
PATIENT IDENTIFICATION AND CONFIDENTIALITY ................................................................................. 13 
10 
ENROLMENT AND PROCEDURES ........................................................................................... 13 
10.1 
ENROLMENT ...................................................................................................................................... 13 
10.2 
DATA COLLECTION ............................................................................................................................ 13 
10.3 
VISIT A: INTERVENTIONAL PROCEDURE ........................................................................................... 14 
10.4 
VISIT B: POST PROCEDURE UNTIL DISCHARGE ............................................................................... 14 
10.5 
VISIT C: POSTPARTUM FOLLOW UP ................................................................................................. 14 
10.5.1 
Chart Abstraction ....................................................................................................................... 15 
10.5.2 
Schedule of Events .................................................................................................................... 15 
10.6 
DISCONTINUATION OF SUBJECTS ..................................................................................................... 15 
11 
CIP ADMINISTRATION ............................................................................................................... 15 
11.1 
AMENDMENTS ................................................................................................................................... 15 
11.2 
DEVIATIONS ...................................................................................................................................... 15 
11.3 
STUDY TERMINATION ........................................................................................................................ 16 
12 
SAFETY ........................................................................................................................................ 16 

 
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12.1 
ADVERSE EVENT REPORTING .......................................................................................................... 16 
12.2 
ADVERSE EVENTS OF SPECIAL INTEREST (AESI) ........................................................................... 16 
12.3 
SERIOUS ADVERSE EVENTS (SAE) ................................................................................................. 17 
12.4 
ADVERSE DEVICE EFFECTS (ADE) & SERIOUS ADVERSE DEVICE EFFECTS (SADE) .................. 18 
12.5 
REPORTING ADVERSE EVENTS ........................................................................................................ 18 
13 
DATA MANAGEMENT ................................................................................................................ 20 
13.1 
CLINICAL DATA SYSTEM MANAGEMENT ............................................................................................ 20 
13.2 
DATA RETENTION .............................................................................................................................. 20 
14 
MONITORING ............................................................................................................................... 21 
15 
STATISTICAL ANALYSIS ........................................................................................................... 21 
15.1 
DETERMINATION OF SAMPLE SIZE ................................................................................................... 21 
16 
INVESTIGATOR RESPONSIBILITIES ........................................................................................ 21 
16.1 
ETHICS COMMITTEE APPROVAL/IRB ............................................................................................... 21 
16.2 
STUDY CONDUCT .............................................................................................................................. 22 
16.3 
REGULATORY REPORTING ............................................................................................................... 22 
17 
SPONSOR RESPONSIBILITIES ................................................................................................. 22 
17.1 
SUBJECT INSURANCE ....................................................................................................................... 22 
17.2 
COMPLIANCE STATEMENTS .............................................................................................................. 22 
18 
AUDITS AND INSPECTIONS ...................................................................................................... 23 
19 
PUBLICATION POLICY ............................................................................................................... 23 
20 BIBLIOGRAPHY ............................................................................................................................... 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Site Principal Investigator Statement 
 
I have read the protocol entitled, “Medela INVIA Motion NPWT system for prophylactic use 
on surgical incision after cesarean delivery” and I agree to participate and comply with the 
procedures and requirements as outlined in this protocol.  I will provide all study personnel 
under my supervision with copies of the protocol and access to all information provided by 
the sponsor.   
 
___________________________________  
 
________________ 
Signature of Principal Investigator 
 
 
 
Date 
 

 
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1 
Synopsis 
Study title 
Short Title: The Invia Motion at Cesarean Study  
Full Title: Medela INVIA Motion NPWT system for prophylactic use 
on surgical incision after cesarean delivery 
Coordinating 
investigator(s) 
Methodius Tuuli, MD, MPH 
Division of Maternal Fetal Medicine  
Department of Ob/Gyn 
Indiana University School of Medicine 
550 N. University Boulevard, UH 2440 
Indianapolis, IN 46202 
Study objective 
To assess patient centered outcomes of the Medela INVIA Motion 
prophylactic NPWT system at cesarean delivery 
Study design 
A two-center feasibility case series. This study is designed to be 
performed in accordance with the Declaration of Helsinki, ISO 
14155:2011(E), ICH-GCP, Local and National Regulations. 
Study duration 
First subject enrolled: December, 2019 
Expected time of enrolment: 6 Months 
Last Follow Up Visit: May, 2019 (1 month follow up) 
Study sites 
Up to 2 sites 
Study population 
Women undergoing cesarean delivery 
Inclusion criteria 
1. Scheduled/non-labor or unscheduled/labor cesarean 
delivery 
2.Gestational age ≥ 23 weeks 
Exclusion criteria 
1.Unwilling or unable to provide consent 
2.Non-availability for postoperative follow-up 
3.Contraindication to NPWT 
• 
Pre-existing infection around incision site 
• 
Bleeding disorder 
• 
Therapeutic anticoagulation 
• 
Allergy to any component of the dressing (e.g., silver, 
silicone, adhesive tape) 
• 
Prior irradiated skin 
Primary endpoint 
Patient centered outcomes 
• 
Pain scores (scale of 0 - 10) at discharge and 
postoperative day 30 (+/-2 days) 
• 
Patient satisfaction scores (scale of 0 - 10) at discharge 
and postoperative day 30 (+/- 2 days) 
• 
Patient satisfaction with aesthetic appearance (scale of 0 
- 10) at postoperative day 30 (+/- 2 days) 
Secondary endpoint  
Efficacy outcome 
• 
Composite wound complication including wound infection, 
would separation, seroma, antibiotics prescribed for 
presumed SSI within 30 days (+/- 2 days) 
Safety outcomes:  
• 
Skin blistering, allergic reaction, wound bleeding  
Study device 
Invia Motion 
 
Reference device 
Not applicable 
 

 
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2 
Contact information 
Contacts could be updated during the study independently from the CIP. 
 
Coordinating investigator(s)  
Company name: Indiana University 
Address:  
Department of Obstetrics and 
Gynecology 
550 N. University Boulevard, UH 
2440 
Indianapolis, IN 46202 
Name: Methodius Tuuli, MD, MPH 
Title: Professor, Vice Chair for 
Obstetrics 
Phone: 678 558 2874 
Fax: 317 944 7417  
Email: mtuuli@iu.edu 
 
 
3 
Participating institutions 
Participating institutions could be updated during the study independently from the CIP. 
Principal investigator(s) 
Participating institution 
Methodius Tuuli, MD, MPH 
Department of Obstetrics and 
Gynecology 
550 N. University Boulevard, 
UH 2440 
Indianapolis, IN 46202 
IU Health Methodist Hospital 
Methodius Tuuli, MD, MPH 
Department of Obstetrics and 
Gynecology 
550 N. University Boulevard, 
UH 2440 
Indianapolis, IN 46202 
Eskenazi Hospital 
 
 
 
4 
Abbreviations 
SSI 
Surgical Site Infection 
NPWT 
Negative Pressure Wound Therapy 
HAI 
Hospital Associated Infection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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5 
Introduction 
Surgical site infections (SSIs) are now the most common group of healthcare 
associated infections (HAIs) and are a significant cause of preventable morbidity and mortality 
in the United States.1  These infections result in significant patient suffering and excess health 
care costs up to $10 billion each year. 1 For these reasons, prevention of HAIs is a top priority 
for the US Department of Health and Human Services and the Institute of Medicine.2.3 
Although several initiatives target HAIs, few are directed at SSIs after cesarean despite the 
fact that cesarean is the most common major surgical procedure performed in women.  In 
2013, 1.3 million cesareans were performed in the US and up to 12% of these were 
complicated by SSIs.4,5  
Negative pressure wound therapy (NPWT) is a closed, sealed system that applies 
negative (or sub-atmospheric) pressure to the wound surface.  Used since the 1990s to treat 
open wounds, experimental evidence suggests that NPWT promotes wound healing by 
removing exudates, approximating the wound edges, and reducing bacterial contamination.6-
16 Three brands of a modified, single-use, battery-powered, portable NPWT devices 
PrevenaTM (KCI USA, San Antonio, TX), PICOTM (Smith & Nephew, Hull, UK) and Invia Motion 
(Medela) have been FDA-cleared for prophylactic application after wound closure at the time 
of surgery.  Although the precise mechanism of action of prophylactic NPWT is unclear, 
experimental evidence suggests that NPWT reduces bacterial contamination, edema, and 
exudates while increasing microvascular blood flow and promoting granulation tissue by 
inducing mechanical stress that promotes cell growth.17 - 21 Computer and physical models of 
NPWT applied to closed incisions demonstrate a decrease in lateral tensile stress by 50% and 
in shear stress by more than 75%, leading to improved apposition of wound edges.22  
Increasing data suggest potential efficacy of prophylactic NPWT for prevent SSI and 
other wound complications after cesarean. This is supported by a recent systematic review 
and meta-analysis which included use of the PICO or Prevena, but was limited by the 
inclusion of studies with small sample sizes or retrospective design 23. Two large 
retrospective studies are underway to define the role of prophylactic NPWT at cesarean. 
However, none of the studies to date have included use of the Medela Invia Motion device. 
This study is a prospective case series to assess patient centered outcomes of the Medela 
INVIA Motion prophylactic NPWT system at cesarean delivery 
 
6 
Study device(s) 
This study will be a prospective study involving the use of 30 FDA-approved Invia Motion 
devices. 
 
6.1 
Study device description 
The Invia Motion NPWT system is comprised of the Invia Motion pump, Invia Motion 
Canister/Tubing Set with 150ml capacity, Invia Motion Power Supply and Invia Motion 
Carrying Case.  Additionally, several separately cleared accessories and kits are 
compatible with the Invia Motion NPWT System.  
 
The Invia Motion pump is a rechargeable battery powered, maintenance-free pump for 
Negative Pressure Wound Therapy which incorporates a DC-motor with membrane 
aggregate power actuation in its housing. A user friendly interface, based on 4 tactile 
buttons and a display, facilitates use and information handling.  The Invia Motion NPWT 
pump provides treatment status through a display and acoustic signals. It is a single 
patient use pump which provides continuous or intermittent operation and multiple 
negative pressure selection options. The Invia Motion NPWT pump is portable and its 
rechargeable battery duration generally exceeds 10 hours, supporting various activities 
of the patient during the day. Acoustic and optical signals are triggered for variances 
from the set values as well as for faults. 
 
The Invia Motion NPWT system provides convenience to the patient and provider.  Every 
patient receives their own personal pump for the duration of therapy.  The small size and 

 
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light weight promote mobility for the patient.  The pump is quiet and replacement of the 
canister is quick and easy.   
The Invia Motion NPWT system comes with a discrete carrying case and battery 
autonomy of up to 10 hours to promote mobility of the patient. 
 
6.2 
Accessory(ies) description 
The Quick-connector interface provides easy and secure attachment between the 
dressing tubing and the canister tubing.  
 
Invia Foam Dressing Kit with FitPad suction interface consists of: 
• 
Charcoal foam, manufactured using a reticulated polyether and polyurethane 
hydrophobic material 
• 
FitPad suction interface with Quick-connector 
• 
Transparent film (one or more pieces depending on the kit size) 
• 
All components are packaged together and sterilized using ethylene oxide (EO) 
• 
Invia Foam Dressing Kit is available in four sizes: Small, Medium, Large and X-
Large 
 
Invia Gauze Dressing Kit with FitPad suction interface consists of: 
• 
Sterile Kerlix Gauze with PHMB 
• 
Sterile Saline 
• 
Sterile packaged FitPad suction interface with Quick-connector 
• 
Sterile packaged Transparent film (one or more pieces depending on the kit size) 
• 
All components placed together in a plastic bag 
 
Y-connector: Allows treatment of two wound sites on the same patient with a single 
device. 
 
Transparent film (single sterile item) available as a separate item. Size is 26cm x 32cm. 
 
Invia Silverlon NPWT Antimicrobial Wound Contact Dressing.  Provides a barrier to 
bacterial penetration using silver ions activated by moisture delivered in the dressing 
which can help reduce infection. Available in two sizes: 
• 
4” x 5” (10 x 12 cm) 
• 
5” x 8” (12 x 20 cm) 
 
*Not all accessories will be used on all enrolled patients. 
 
6.3 
Study device intended use 
Invia Motion Devices 
The Invia Motion NPWT system is intended to be used by healthcare professionals or 
adequately trained lay users. Healthcare professionals are responsible to train lay users 
according to the patient instructions for use and explain all related safety information.  
 
Intended patient population 
The Invia Motion NPWT system is intended to be used on patients only exhibiting 
conditions as described in the indications for use. The device has not been studied in 
pediatric patients. 
 
Intended environment 
The Invia Motion NPWT system is intended for use in acute, extended and home care 
settings. 
 
 
 

 
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Indications for use 
The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for 
patients who would benefit from a suction device (NPWT) as when used on open 
wounds it creates an environment that promotes wound healing by secondary or tertiary 
(delayed primary) intention by preparing the wound bed for closure, reducing edema, 
promoting granulation tissue formation and perfusion, and by removing exudate and 
infectious material. When used on closed surgical incisions, the Invia Motion NPWT 
system is also intended to manage the environment of surgical incisions that continue 
to drain following sutured or stapled closure by maintaining a closed environment and 
removing exudate via the application of NPWT. 
 
The Invia Motion NPWT system is appropriate for the following indications: 
– Acute or subacute wounds 
– Chronic wounds 
– Dehisced wounds 
– Pressure injuries, Pressure ulcers 
– Diabetic/Neuropathic ulcers – Venous insufficiency ulcers – Traumatic wounds 
– Partial thickness burns 
– Flaps and grafts 
– Closed surgical incisions 
 
Contraindications 
The Invia Motion NPWT system is contraindicated in the presence of: 
– Necrotic tissue with eschar present – Untreated osteomyelitis 
– Non-enteric and unexplored fistulas – Malignancy in the wound 
– Exposed vasculature 
– Exposed nerves 
– Exposed anastomotic site of blood vessels or bypasses – Exposed organs 
 
Dressing Kits 
The Invia Foam Dressing Kit with FitPad is intended for use in conjunction with the Invia 
Motion and Invia Liberty NPWT systems. The Invia Motion and Invia Liberty NPWT 
systems are intended for use in acute, extended and home care settings. Users are 
directed to the Invia Motion and Invia Liberty NPWT system labeling for additional safety 
information and instruction for use. To help ensure safe and effective use, the Invia 
Foam Dressing Kits with FitPad are to be used only with the approved therapy units. 
The components of the Invia Foam Dressing Kit with FitPad are packaged sterile and 
are for single use only. Do not use if sterile package is damaged or opened prior to use. 
To apply Invia Foam Dressing Kit with FitPad, use clean/aseptic or sterile techniques in 
accordance with local protocol. 
Important: Failure to consult a physician and carefully read and follow all therapy unit 
and dressing instructions for use and safety information prior to each use may lead to 
inadequate performance of the product and/or potential for serious or fatal injury. Do not 
adjust therapy unit settings or use unit without directions from or supervision by the 
prescribing physician. 
 
The Invia Foam Dressing Kit with FitPad in conjunction with Invia Motion and Invia 
Liberty NPWT systems is indicated for patients who would benefit from a suction 
device (NPWT) as when used on open wounds, it creates an environment that 
promotes wound healing by secondary or tertiary (delayed primary) intention by 
preparing the wound bed for closure, reducing edema, promoting granulation tissue 
formation and perfusion, and by removing exudate and infectious material.  
When used on closed surgical incisions, the Invia Foam Dressing Kit with FitPad is 
also intended to manage the environment of surgical incisions that continue to drain 
following sutured or stapled closure by maintaining a closed environment and 
removing exudate via the application of Negative Pressure Wound Therapy.  

 
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The Invia Foam Dressing Kit with FitPad is appropriate for use for the following 
indications: 
• 
Acute or sub-acute wounds 
• 
Chronic wounds 
• 
Dehisced wounds 
• 
Pressure injuries, Pressure ulcers 
• 
Diabetic/neuropathic ulcers 
• 
Venous insufficiency ulcers 
• 
Traumatic wounds 
• 
Partial thickness burns 
• 
Flaps and grafts 
• 
Closed surgical incisions 
 
6.4 
Procedure 
Primary or repeat cesarean delivery 
 
6.5 
Training  
The Invia Motion Endure NPWT system is an equivalent system to NPWT devices 
widely used at this Facility.   
 
Onsite, face-to-face training will be provided by Medela representatives to research 
staff who will be involved in the study. 
 
Research and/or clinical staff will instruct the patient on what to do during the 
treatment.  Patient will be provided with Invia Motion Endure NPWT system Patient 
IFU and NPWT APP. 
 
Research and clinical staff trained by Medela representatives will be allowed to train 
any additional staff for the study. 
 
6.6 
Study device management 
6.6.1 Device complaints/malfunction of device 
Complaints are any deficiencies with regards to the study device, instructions for use, 
operator’s manual and other product related documentation. Device complaints may or may 
not involve a clinical event/in this case an adverse device effect to the patient in which case 
the definitions in the section of adverse event reporting of this clinical investigation plan shall 
also apply. 
 
6.6.2 Reporting of complaints 
Any complaints on the device, instructions for use, operator’s manual and other product 
related documentation shall be reported to the CRA using the appropriate reporting forms. 
Whenever possible in case of malfunction of the study device or part of study device, the 
product in question shall be returned to the Sponsor for investigation. The appropriate 
procedure for such return shall be provided by the Sponsor prior to starting the clinical 
investigation. 
 
6.6.3 Inventory and accountability records 
Adequate records of study product and disposition will be maintained by the research 
staff at both study sites.  The purpose of these records is to ensure regulatory 
authorities that the study product will not be distributed to any person who is not a 
study subject under the terms and conditions set forth in the protocol.  The study 
product is to be prescribed by the Investigator or designees and may not be used for 
any purpose other than that described in this protocol.  At study completion, all study 
products must be returned to Medela USA. 
 

 
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6.6.4 Device storage 
Devices will be stored in a secure storage location at the site.  
 
 
6.6.5 Device return 
Upon completion of the study, all unused devices must be returned to Medela USA 
according to the local agents' instruction. 
 
7 
Risk analysis 
7.1 
Risks  
The Single Use Prophylactic Negative Pressure Wound Therapy System received FDA 
marketing approval in 2012.  As of September 2015, we identified two reports on the FDA 
website of blistering at the site of application from the PICO device.  A third report of a minor 
burn from the PICO pump device occurred in a patient after neurosurgery while still 
unconscious. The patient was found to have been lying on the pump device for a prolonged 
period of time.  Case series suggest approximately 10-15% rate of skin irritation and blisters 
at the device application site. The majority (~90%) did not require treatment beyond removal 
of the device.24, 25 Moreover, adverse events noted with NPWT after cesarean were minor and 
comparable in frequency to standard dressing.26  
 
7.2 
Benefits 
The study is not designed to provide direct benefits to research participants. Nonetheless, if 
our hypothesis that women will have lower rates of SSIs after cesarean with use of 
prophylactic NPWT than with standard care is correct, then patients will have the benefits 
lower rates of SSIs.  More importantly, results from this study have the potential to improve 
outcomes for women undergoing cesarean delivery.  
 
7.2.1 Risk-to-benefit rationale  
Because the anticipated risk to participants is minimal, the risk-benefit ratio is very favorable. 
 
8 
Investigational plan 
8.1 
Study objectives  
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT 
system at cesarean delivery. 
 
8.2 
Study hypotheses  
We test the hypothesis that the Medela INVIA Motion prophylactic NPWT system will be 
feasibly used at cesarean delivery with significant patient satisfaction. 
 
8.3 
Claims to verify 
Feasibility of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery with 
significant patient satisfaction. 
 
8.4 
Risks to assess 
<10% device related adverse events including skin blistering, allergic reaction and 
wound bleeding.  
 

 
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8.5 
Study design 
This study will be a two center case series of women undergoing caesarean delivery 
conducted at two medical centers in Indianapolis, Indiana. 
All patients meeting inclusion criteria will be included. All enrolled patients will receive the 
Medela INVIA Mation prophylactive NPWT device. 
 
8.6 
Primary Endpoint 
Patient centered outcomes 
• 
Patient satisfaction scores (scale of 0 - 10) at discharge and postoperative day 30 
(+/- 2 days) 
• 
Pain scores (scale of 0 - 10) at discharge, at removal and postoperative day 30 (+/- 
2 days) 
• 
Patient satisfaction with aesthetic appearance (scale of 0 - 10) at postoperative 
day 30 (+/- 2 days) 
 
8.6.1 Secondary endpoints  
Efficacy outcome 
• 
Composite wound complication including wound infection, would separation, 
seroma, antibiotics prescribed for presumed SSI within 30 days (+/- 2 days) 
 
Safety outcomes:  
• 
Skin blistering, allergic reaction, wound bleeding  
 
9 
Subject selection 
Patients will be enrolled at any time after 23.0 weeks gestation and prior to cesarean  
 
9.1 
Inclusion criteria 
1. Scheduled/non-labor or unscheduled/labor cesarean delivery 
2. Gestational age ≥ 23 weeks 
 
9.2 
Exclusion criteria 
1. Unwilling or unable to provide consent 
2. Non-availability for postoperative follow-up 
3. Contraindication to NPWT 
• 
Pre-existing infection around incision site 
• 
Bleeding disorder 
• 
Therapeutic anticoagulation 
• 
Allergy to any component of the dressing (e.g., silver, silicone, adhesive tape) 
• 
Prior irradiated skin 
 
9.3 
Withdrawal criteria and procedure 
Patients will be withdrawn from the study for any of the following reasons: 
1. Patient requests early discontinuation. 
2. Patient undergoes removal of the study device 
3. Patient is lost to follow up. 
The patient can leave the investigation at any time, at the patient’s request. The reason for 
withdrawal will be investigated and carefully documented in the Patient’s Medical file and the 
appropriate section of the Case Report Form. When a patient withdraws or is withdrawn from 
the study, the final evaluation and the follow up will be performed as completely as possible. 
In addition, any comments (spontaneous or elicited) or complaints made by the patient or 
any other physician not related to the investigation but taking care of the patient 

 
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subsequently will be carefully recorded in the Patient’s Medical File and related section of 
the Case Report Form. 
 
9.4 
Patient Identification and Confidentiality 
Patients will be identified on all CRFs by a unique number. CRFs are confidential documents 
and will only be available to the sponsor (including sponsor delegates, like CRAs), the 
Investigator, the investigation statistician, and if requested to the advisory committee and 
regulatory authorities. The Principal Investigator for each centre will maintain as part of the 
investigation file a list identifying all patients entered into the trial. 
 
10 Enrollment and Procedures 
Patients will be enrolled at any time after 23.0 weeks gestation and prior to cesarean 
delivery.  Enrollment activities may occur at prenatal appointments or upon admission to the 
Labor and Delivery unit.  Each center will have the flexibility to use an approach that is most 
efficient and suitable for their system to screen and consent patients. Medical records of all 
potential patients will be reviewed and those who satisfy inclusion and exclusion criteria will 
be approached and written informed consent obtained.  A screening log will be used to track 
all patients approached for the study (see Flow Chart below).   
 
10.1 Enrollment 
Patients will be considered enrolled in the study once they have provided documented 
consent. Consent from patients will be obtained in a private setting, such as a quiet 
conference area or the patient’s private room.  All subjects will be provided a copy of the 
signed informed consent form to take home. The informed consent process will be 
documented. There will be no randomization. All patients enrolled will receive the Medela 
INVIA Motion system. 
 
10.2 Data collection 
We will collect detailed antepartum, intrapartum, and postpartum information from study 
participants into a comprehensive database. Data will be collected and managed with 
REDCap (Research Electronic Data Capture), an established, secure, web-based data 
capture and management tool developed at Vanderbilt University and supported by the 
bioinformatics team at Indiana University School of Medicine 

 
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• 
Trained research staff in obstetric 
and perinatal outcomes abstraction 
will be responsible for all research 
data abstraction from patient records   
• 
Research 
staff 
will 
undergo 
centralized 
specific 
training 
to 
ascertain study outcomes 
• 
Standardized information will be 
abstracted from all charts regardless 
of study group 
• 
Relevant data will be collected 
initially to assess eligibility. Complete 
baseline, outcome, wound culture, 
and cost data will be collected via 
direct interview and chart review 
• 
Several data collection forms will be 
used 
during 
these 
processes, 
including forms for maternal baseline 
data, preoperative and intraoperative 
care, 
maternal 
outcomes, 
postpartum clinic/hospital outcomes 
• 
Data on these forms devoid of 
personal identifiers will be securely 
sent to the data management center through web-based entry 
 
10.3 Visit A: Interventional Procedure  
All enrolled patients will receive the Medela INVIA Motion device placed by the patient’s 
surgeon after the skin is closed with subcuticular suture or staples. Research staff and 
clinicians (labor & delivery and postpartum nurses, OR technicians, physicians, etc.) involved 
in the study will receive formal training on how to place and remove the prophylactic NPWT 
device.  
 
10.4 Visit B: Post Procedure until Discharge 
• 
Patients will be monitored daily while in the hospital by clinical staff and/or research 
staff for complications. 
• 
The negative pressure wound therapy dressing will be removed on the day of 
discharge. If the patient remains hospitalized for more than 7 days, the dressing 
will be removed on postoperative day 7.  
• 
Replacement of any dressing that is saturated.  
• 
If a patient develops infection with the NPWT device in place the device will be 
removed and the patient given standard SSI therapy as outlined below. 
• 
Patients will be educated about the signs and symptoms of infection and other 
study outcomes and encouraged to call their provider if these should arise. 
• 
Research staff document inpatient course regarding SSI. 
• 
Management of surgical site infections will follow the Practice Guidelines of the 
Infectious Diseases Society of America. 
 
10.5 Visit C: Postpartum Follow Up  
We will use active surveillance by research staff to ascertain surgical site infections:  
• 
Research staff will follow-up with the research participant at time of discharge or within 
48 hours post discharge (postpartum day 1-9) to assess for adverse events, assess 
the participant’s pain, obtain their satisfaction with their dressing and aesthetic 
appearance of the incision. 
• 
A $25 gift card will be disbursed to the participant. 

 
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• 
Research staff will call subjects on approximately postoperative day 30 (±2 days).  
They will ask the patient standardized questions regarding wound complications, 
patient satisfaction, pain and aesthetic appearance.  If the patient reports a hospital, 
clinic, or ER visit not associated with the study centers, the staff will obtain the name 
of the medical facility and request the records.  
• 
The EQ-5D-3L quality of life questionnaire will be administered at the 30-day call. 
• 
Medical records from postpartum clinic visits as well as records of unscheduled visits 
(to any hospital clinic or ER) will be sought to ascertain study outcomes.  
• 
At the time of the subject’s standard of care postpartum appointment about 4-6 weeks 
after inpatient hospital discharge research staff will collect information on outcomes, 
pain and patient satisfaction.  If the patient does not attend the clinical postpartum visit, 
the study staff will contact the subject by phone to collect the data. A $50 gift card will 
be disbursed to the participant once this postpartum visit is complete. 
 
10.5.1 Chart Abstraction  
Data from the subject’s prenatal record, delivery admission, and all clinic or hospital visits 
through the 6 week postpartum period, including medications and procedures will be 
collected. 
 
10.5.2 Schedule of Events  
 
  
Enrollment 
At Discharge or 
Within 48 hours Post 
Discharge (PP Day 
1-9)   
Post-Op Day 
30 (+/- 2 days) 
Post-Op ~4-6 Weeks 
Postpartum Visit 
Eligibility 
X 
  
 
  
Interview: Maternal Demographic 
Characteristics 
X 
  
 
  
Chart abstraction: Prenatal Records 
  
X 
 
  
Chart abstraction: Labor & Delivery 
  
X 
 
  
Patient Satisfaction Survey 
  
X 
X 
X  
AE/SAE Form (if applicable) 
  
X 
X 
X 
Chart abstraction: Outcome 
Assessment 
  
X 
 
X 
Disburse gift card 
 
X 
 
X 
Chart abstraction: Postpartum 
  
  
 
X 
 
10.6 Discontinuation of subjects 
If a patient develops a wound complication the Principal Investigator or patient’s provider will 
determine if the NPWT device should be discontinued. 
 
11 CIP administration 
The Principal Investigator has a legal responsibility to the regulatory authorities to fully report 
all the results of sponsored clinical studies. No investigative procedures other than those 
stated in this CIP shall be undertaken on the enrolled clinical investigation subjects without 
the agreement of the IRB and PI. 
 
11.1 Amendments  
Amendments to the CIP can be made by the investigator and will be communicated to 
Medela AG. All changes must be documented in a signed CIP amendment. All amendments 
must be submitted to the IRB for approval prior to implementation. 
 
11.2 Deviations  
Any deviation from the CIP shall be recorded together with an explanation for the deviation. 
Medela shall be informed about deviations. Investigator is responsible for analysing them 
and assessing their significance. 
Significant deviations defined as compromising or potentially compromising the safety of the 
patients, enrollment of non-eligible patients and any deviation which compromises 

 
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significantly the outcomes of the study, shall be subject to reporting by Investigator to the 
IRB within the appropriate deadlines indicated by the IRB. 
Note: Where relevant, Competent Authorities should be informed. 
 
11.3 Study termination 
Medela AG will be allowed to monitor the progression of the clinical investigation. Medela 
and the Institution shall jointly agree on the scope and plan of the monitoring. If warranted, 
the clinical investigation may be suspended or discontinued by Investigator early if there is 
an observation of serious adverse reactions presenting an unreasonable risk to the clinical 
investigation population. 
In the event of clinical investigation termination or suspension, Investigator will send a report 
outlining the circumstances to the IRB, and all l investigators. A suspended or terminated 
clinical investigation may not be re-initiated without approval of the reviewing IRB. 
 
12 Safety 
NPWT is currently used in clinical obstetric practice. Further, the adverse events reported with 
the use of prophylactic NPTW at cesarean were minor. Therefore, no serious or life-
threatening adverse events are expected in this trial. Nonetheless, the following measures will 
be taken to monitor and investigate adverse events.  
 
12.1 Adverse Event Reporting 
During the course of this clinical investigation adverse events might occur. For the purposes 
of this study the following categories of adverse events are relevant for reporting: 
• 
Adverse Event of Special Interest (AESI) 
• 
Serious Adverse Event (SAE) 
• 
Adverse Device Effect (ADE) 
• 
Serious Adverse Device Effect (SADE) 
 
Subjects will be evaluated for adverse events in the following manner: 
• 
Routine monitoring by physicians, nurses and research team during inpatient stay, 
with data obtained from the subject’s EMR by research staff. 
• 
Patients will be scheduled for standard of care follow-up with their provider at 1-2 
weeks and 4-6 weeks postpartum. Research staff will review the subject’s EMR 
after 6 weeks postpartum. 
• 
Medical records will be sought for any patient or provider-reported complications. 
 
12.2 Adverse Events of Special Interest (AESI) 
For this study, abnormal laboratory findings (e.g., clinical chemistry, hematology) or other 
abnormal assessments (e.g., electrocardiogram, X-rays, vital signs) per se are not reported 

 
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as AEs. Only Adverse Events of Special Interest (AESI) defined below will be recorded on the 
CRFs and in the subject’s chart.  
 
For this study, AESIs refer to:  
• 
Mild/moderate reactions: 
o Skin blisters 
o Wound bleeding 
o Allergic skin reaction 
 
Any current condition that is recorded as a pre-existing condition in the medical history, unless 
there is a change in nature, severity, or degree of incidence, is not an AE.  
 
Relation to the clinical investigation device will be assessed by help of the following criteria:  
• 
Related 
• 
Not related 
 
Relation to the procedure will be assessed by help of the following criteria: 
• 
Related 
• 
Not related 
 
12.3 Serious Adverse Events (SAE) 
A serious adverse event (SAE) is any adverse event that results in any of the following 
outcomes: 
• 
Maternal death 
• 
Serious deterioration in the health of the subject, that either resulted in 
1) A life-threatening illness or injury, or 
2) A permanent impairment of a body structure or a body function, or 
3) In-patient or prolonged hospitalization, or 
4) Medical or surgical intervention to prevent life-threatening illness or 
5) Injury or permanent impairment to a body structure or a body function 
 
Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
This also applies to adverse events that may not be immediately life-threatening or result in 
death or hospitalization but may jeopardize the subject or may require intervention to prevent 
one of the other outcomes listed above. 
 
The assessment of 'seriousness' is independent from any relation to the investigational device. 
 
Hospitalization is defined by a medical need for in-patient hospitalization overnight. For 
procedures that are commonly performed in out-patient clinic but yet requires hospitalization 
solely based on non-medical needs (e.g. logistical reasons) this criterion could be considered 

 
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not applicable by the Investigator. Proper documentation of the reasons for decision is 
required in this case. 
 
Events that are planned (e.g. elective surgery) and documented prior to clinical investigation 
entry will not be recorded if the procedure is performed without any complications. Medication 
received during this activity may be recorded.  
 
12.4 Adverse Device Effects (ADE) & Serious Adverse Device Effects (SADE) 
An adverse device effect is an adverse event related to the use of a study medical device 
 
This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
 
This definition also includes any event resulting from user error or from intentional misuse of 
the investigational medical device.  
 
An ADE is classified as serious if it has resulted in any of the consequence characteristics of 
a serious adverse event or that might have led to any of these consequences if suitable action 
had not been taken or intervention had not been made or if circumstances had been less 
opportune. 
 
If an ADE or SADE has occurred any retrievable part of the Invia® Motion™ Endure NPWT 
system should be returned to Medela AG for analysis. If there is also a suspected relation to 
accessory material (guide wire etc.) the accessory material in question should also be sent to 
Medela AG for analysis. 
 
12.5 Reporting Adverse Events 
An adverse event report will be generated for each event that will include the following: 
• 
Date of event discovery 
• 
Severity (mild, moderate, severe, life threatening/disabling, death) 
• 
Relationship to treatment 
• 
Action taken 
• 
Outcome 
• 
Expected or unexpected 
• 
Date reported  
• 
Relevant notes/chart records/supporting documentation to corroborate the 
event 
• 
To whom event was reported (IRB, Sponsor) 
o Non-Severe AESIs and ADEs will be reported to the 
Sponsor every 6 months, and to the IRB at renewal.  
o SAEs and USADEs will be reported within 24 hours of 
discovery to the IRB and the Sponsor. 
 
Relationship of Reportable Events: 
An Investigator must make the determination of relationship to the drug for each AESI/ADE. 
The relationship to the device should be assessed using the guidelines presented in the 
table below.  
 
Relationship to 
Device 
Description  
Related  
• Previously known harmfulness of device; or 
• Follows a reasonable temporal sequence from administration of the 
device; or  

 
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• Follows a known or expected response pattern to the suspected 
intervention; or 
• Is confirmed by stopping or discontinuing the device; and  
• That is not explained by any other reasonable hypothesis  
Probably related  
• Follows a reasonable temporal sequence from the time of study 
intervention; and/or  
• Follows a known response pattern to the study device; and  
• Was unlikely to have been produced by other factors such as the 
subject’s clinical state, therapeutic intervention, or concomitant therapy  
Possibly related  
• Follows a reasonable temporal sequence from the time of study 
intervention; and/or  
• Follows a known response pattern to the study device; but  
• Could have been produced by other factors such as the subject’s 
clinical state, therapeutic intervention, or concomitant therapy  
Unlikely related  
• Does not follow a reasonable temporal sequence from the time of study 
intervention; and  
• Was likely produced by other factors such as the subject’s clinical state, 
therapeutic intervention, or concomitant therapy but for which 
relationship cannot be definitely ruled out  
Not related  
The adverse event can be determined with certainty to have no 
relationship to the study device 
 
Severity of Reportable Events:  
The investigator will assess the severity of the AE using the following general guidelines:  
Severity 
Description 
Mild: 
An AE that is usually transient, requiring no special treatment, 
and does not interfere with the subject’s daily activities.  
Moderate: 
An AE that introduces a low level of inconvenience or concern to 
the subject and may interfere with daily activities but is usually 
ameliorated by simple therapeutic measures.  
Severe: 
An AE that interrupts a subject’s usually daily activity and 
typically requires systemic drug therapy or other treatment (a 
severe AE may not necessarily qualify as an SAE).  
Life-threatening: 
An AE that put the subject at immediate risk of death from the 
event as it occurred. This does not include an event that might 
have led to death if it had occurred with greater severity.  
 
 
Outcomes of Reportable Events: 
The investigator will categorize the outcome of each reportable event according to the 
definitions below:  
 
Status 
Description 
Resolved: 
The subject recovered from the SAE or AESI.  
Resolved with 
sequelae: 
A condition whereby the consequences of a disease or injury 
include lingering effects.  
Ongoing: 
At the time of the last assessment, the event is ongoing, with an 
undetermined outcome. Note: Ongoing SAEs and AESIs are not 
considered resolved as a result of death and no SAE or AESI 
stop date should be recorded for an AESI that is ongoing at the 
time of death.  
Fatal: 
Adverse Event directly caused death. If a subject dies during 
participation in the study the lead site should be provided with a 
copy of any post-mortem findings. Note: Death is an outcome of 

 
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an adverse event and not an adverse event in itself. All reports of 
subject death should include an adverse event term (other than 
“Death”) for the cause of the death.  
 
13 Data management 
Qualified study staff at the investigational site will perform primary data collection. Paper 
source will be used to collect all subject data during the study. All study data will then be 
entered into REDCap in electronic case report forms (eCRFs). The investigator is 
responsible for the accuracy and completeness of all data on the eCRFs. Site personnel will 
review completed eCRFs at regular intervals throughout the study.  
Information on the eCRFs will be compared for completeness, validity, and consistency to 
information originally recorded on source documents related to the study. Information on the 
eCRF must match the same information on the source documents or a data query will be 
issued.  
 
The PI/data manager is responsible for providing a clean data set at the end of the clinical 
investigation. Queries should be resolved by the investigator or a person designated by the 
investigator in a timely manner. When all data is complete the database will be locked and the 
data analyzed. 
 
Quality control audits of all key performance and safety data in the database will be made 
after 90% of all data have been entered and processed.  Prior to database lock, the entire 
database will be re-validated to ensure that there are no outstanding errors.  When all 
queries have been resolved, the database will be locked.  Any changes to the database after 
that time will require joint written agreement between the PI and Sponsor.  
The Investigator is responsible for reporting appropriately and in a legible manner the 
requested information in the CRFs. 
The medical/ subject record (source document) must contain but is not limited to the 
following information: 
• 
Date of informed consent 
• 
Subject participation in the clinical investigation  
• 
Demographics  
• 
Dated reports of the discharge  
• 
Documentation of medical/ surgical history and current medication  
• 
Description of device procedure (material used, date, time, complications etc.) 
• 
All AESI, SAE, ADE, or SADEs: Diagnosis and symptom(s), onset and end date, 
severity, action taken, outcome 
• 
Concomitant medication 
• 
Date of clinical investigation completion or withdrawal  
 
13.1 Clinical data system management 
Data will be managed at Indiana University. Data will be collected and managed with 
REDCap (Research Electronic Data Capture), an established, secure, web-based data 
capture and management tool developed at Vanderbilt University and supported by the 
bioinformatics team at IU. The security of the database will be maintained by the use of 
dedicated password protected encrypted computers with multiple private backups (daily, 
weekly, and monthly including on- and off-site storage for protection against disaster).   
 
13.2 Data retention 
All clinical investigation records and reports must remain on file at the clinical investigation 
centers for the minimum time given by the national legislation.  
 
The investigator must contact Medela AG before destruction of any records and reports related 
to the clinical investigation. Medela AG must be informed if the investigator plans to leave the 

 
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clinical investigation site. In such case the site must name a new contact person before the 
investigator parts from the clinical investigation site. 
 
Medela AG will retain the Trial Master File (TMF) according to national legislation and Medela 
AG Standard Operating Procedure (SOPs). 
 
Medela AG is responsible for instructing all involved parties to maintain clinical investigation 
records according to national regulations. 
 
14 Monitoring 
Monitoring will be performed by Medela AG or by Medela AG designees and the PI to ensure 
that the investigator and the clinical investigation team conducts the clinical investigation in 
accordance with the CIP, Declaration of Helsinki, ISO 14155:2011(E), ICH-GCP and 
applicable regulations to ensure adequate protection of the rights, safety and wellbeing of 
subjects and the quality and integrity of the resulting data. 
 
The monitor will verify that records on the clinical investigation conduct and data collection are 
complete and present, and that the device accountability is complete 
 
15 Statistical Analysis 
Descriptive statistics will characterize the group of individuals recruited into the study. 
Categorical variables will be reported and proportions while continuous variables will be 
reported as mean and standard deviation or median and interquartile range as appropriate. 
The primary outcome and other categorical secondary outcomes will be reported as 
proportions with 95% confidence intervals. As this is a two-site trial, subgroup analyses will 
be performed by site as well as body mass index. 
 
15.1 Determination of Sample Size 
As this is a feasibility study, no formal sample size estimation is performed. A sample of 30 
will be sufficient to test feasibility and patient reported outcomes. 
 
16 Investigator Responsibilities 
The Investigator will be able to publish and/or present the data generated from the study after 
mutual agreement between the Investigator and Sponsor. The Investigator will provide the 
sponsor with a manuscript copy of the abstract and paper at least 60 days in advance of 
presentation to editors for publication or presentation. 
 
16.1 Ethics Committee Approval/IRB  
The investigator/co-investigator is responsible for the submission to the central/local IRB.  
 
The content of the submitted documents must be documented in writing. A copy of this 
document will be provided to Medela AG. A copy of the IRBopinion/approval together with the 

 
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list of IRB voting members will be provided to Medela AG (or designee) prior to initiating the 
clinical investigation at a particular site. 
 
The investigator is obliged to submit the appropriate documentation if any necessary extension 
or renewal of the IRB approval has to be obtained.  
 
The investigator must report to the IRB any new information that may affect the safety of the 
subjects or the conduct of the clinical investigation.  
 
Upon completion of the clinical investigation, the investigator shall provide the IRB with a brief 
report of the outcome of the clinical investigation as required by the local IRB. 
 
16.2 Study conduct 
Prior to shipment of the first clinical investigation device and first implantation, the investigator 
must read and sign this CIP as well as the Investigator’s Agreement, to document that he/she 
has accepted to conduct the clinical investigation according to all agreed conditions and follow 
the CIP. 
 
Prior to enrolling any subjects in the clinical investigation, all national and local regulatory 
requirements must be fulfilled.  
Each clinical investigation site must have, but is not limited to, the following documents: 
• 
Competent authority approval, if applicable 
• 
Ethics committee approval  
• 
Signed investigator’s agreement 
• 
Signed and dated CVs for all investigators participating in the clinical investigation. 
• 
Laboratory Accreditation and the normal ranges 
 
16.3 Regulatory Reporting 
The investigator is obliged to report in writing to the IRB, any Serious Adverse Event whether 
device related or not within the timelines required by the IRB. Investigator is obliged to report 
in writing to the CA if applicable, any Serious Adverse Event whether device related or not 
within the timelines required by the CA and inform Medela about this report. 
 
17 Sponsor Responsibilities 
Investigator is responsible to apprehend the approval from the Competent Authority (CA), if 
applicable, prior to any site initiation. Investigator must report to the CA any new information 
that may affect the safety of the subjects or the conduct of the clinical investigation and inform 
Medela about this report 
 
17.1 Subject Insurance 
Subjects who participate in this study will be insured against study related injury according to 
local regulatory requirements. Medela AG has issued clinical trial liability insurance with 
appropriate coverage for the continuation of the entire study. 
 
17.2 Compliance statements 
This clinical investigation is designed to be performed in accordance with the Declaration of 
Helsinki 2008, ISO 14155:2011(E), ICH-GCP, Local and National regulations. 
 
Any corrections to the CIP that might become necessary to be in conformity with new 
standards and regulations will be issued as amendments to this CIP. This clinical investigation 
shall not begin until the required approvals from the IRBs and the applicable regulatory 

 
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authorities have been obtained. Any specific requirement imposed by the IRBs or the 
regulatory authority shall be followed. 
 
18 Audits and inspections 
An internal audit is performed by the Institution and its employees. Prior to the internal audit, 
Medela and the Institution shall jointly agree on the scope and plan of the audit. During the 
internal audit, the Institution shall gather and evaluate all records, information and 
documentation within the scope of the audit and, if necessary, conduct interviews with the 
Institution's and/or subcontractor's employees. It shall inform Medela regularly about progress 
and developments of the audit. At the end of the audit, the Institution shall issue a final report 
and hand it over to Medela. 
 
An external audit is performed by Medela or third parties acting on behalf of Medela with 
confidentiality obligations, i.e. auditors and external counsel. Prior to the external audit, 
Medela and the Institution shall jointly agree on the scope and plan of the audit. During the 
external audit, the Institution has comprehensive obligations to cooperate, including but not 
limited to making available all records, information and documentation within the scope of the 
audit, handing over documents (hard copies and electronic documents) and allowing Medela 
or the third party acting on behalf of Medela to conduct interviews with the Institution's 
employees. 
 
19 Publication policy 
The Institution has the sole right to the primary presentation and publication of the Study 
Results, including articles, papers, posters, abstracts, presentations, etc. ("Publication"). 
Before Publication of the Study Results, the Institution or the Principal Investigator shall submit 
the manuscript to Medela and Medela shall have a period of sixty (60) days to review the 
proposed Publication for the disclosure of patentable inventions of interest to Medela and for 
any information considered proprietary or Confidential Information by Medela. If a patentable 
invention of interest to Medela is to be disclosed, the Publication shall be delayed to permit 
Medela to prepare and file a patent application in timely manner. Publication may not be 
delayed more than an additional ninety (90) days to permit the preparation and filing of a patent 
application. If proprietary or Confidential Information of Medela are in the manuscript, the 
Publication shall require approval by Medela before submission to the presenter or publisher.  
The Institution and the Principal Investigator shall have sole responsibility for the scientific  
content of the Publications. The Parties agree that Publications should be made in the first 
place in prestigious scientific periodicals (peer reviewed), in books or at congresses and 
conferences. 
 
20 Bibliography 
1. 
Anderson DJ, Podgorny K, Berrios-Torres SI, et al. Strategies to prevent surgical site 
infections in acute care hospitals: 2014 update. Infection control and hospital epidemiology : 
the official journal of the Society of Hospital Epidemiologists of America 2014;35 Suppl 2:S66-
88. 
2. 
Gibbs RS. Clinical risk factors for puerperal infection. Obstetrics and gynecology 
1980;55:178S-    84S. 
3. 
Hayes JF, Marston L, Walters K, Geddes JR, King M, Osborn DP. Lithium vs. valproate 
vs. olanzapine vs. quetiapine as maintenance monotherapy for bipolar disorder: a population-
based UK cohort study using electronic health records. World psychiatry : official journal of 
the World Psychiatric Association 2016;15:53-8. 
4. 
Kolliakou A, Ball M, Derczynski L, et al. Novel psychoactive substances: An 
investigation of temporal trends in social media and electronic health records. European 
psychiatry : the journal of the Association of European Psychiatrists 2016;38:15-21. 
5. 
Conroy K, Koenig AF, Yu YH, Courtney A, Lee HJ, Norwitz ER. Infectious morbidity 
after cesarean delivery: 10 strategies to reduce risk. Reviews in obstetrics & gynecology 
2012;5:69-77. 

 
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25 
 
 
Version 1.0: 15 November 2019 
 
6.Hasan MY, Teo R, Nather A. Negative-pressure wound therapy for management of diabetic 
foot wounds: a review of the mechanism of action, clinical applications, and recent 
developments. Diabetic foot & ankle 2015;6:27618. 
7. 
Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: 
a new method for wound control and treatment: animal studies and basic foundation. Annals 
of plastic surgery 1997;38:553-62. 
8. 
Morykwas MJ, Faler BJ, Pearce DJ, Argenta LC. Effects of varying levels of 
subatmospheric pressure on the rate of granulation tissue formation in experimental wounds 
in swine. Annals of plastic surgery 2001;47:547-51. 
9. 
Schintler MV. Negative pressure therapy: theory and practice. Diabetes/metabolism 
research and reviews 2012;28 Suppl 1:72-7. 
10. 
Timmenga EJ, Andreassen TT, Houthoff HJ, Klopper PJ. The effect of mechanical 
stress on healing skin wounds: an experimental study in rabbits using tissue expansion. British 
journal of plastic surgery 1991;44:514-9. 
11. 
Timmers MS, Le Cessie S, Banwell P, Jukema GN. The effects of varying degrees of 
pressure delivered by negative-pressure wound therapy on skin perfusion. Annals of plastic 
surgery 2005;55:665-71. 
12. 
Greene AK, Puder M, Roy R, et al. Microdeformational wound therapy: effects on 
angiogenesis and matrix metalloproteinases in chronic wounds of 3 debilitated patients. 
Annals of plastic surgery 2006;56:418-22. 
13. 
Gustafsson R, Johnsson P, Algotsson L, Blomquist S, Ingemansson R. Vacuum-
assisted closure therapy guided by C-reactive protein level in patients with deep sternal wound 
infection. The Journal of thoracic and cardiovascular surgery 2002;123:895-900. 
14. 
Patmo AS, Krijnen P, Tuinebreijer WE, Breederveld RS. The Effect of Vacuum-
Assisted Closure on the Bacterial Load and Type of Bacteria: A Systematic Review. Advances 
in wound care 2014;3:383-9. 
15. 
Noble-Bell G, Forbes A. A systematic review of the effectiveness of negative pressure 
wound therapy in the management of diabetes foot ulcers. International wound journal 
2008;5:233-42. 
16. 
Seo SG, Yeo JH, Kim JH, Kim JB, Cho TJ, Lee DY. Negative-pressure wound therapy 
induces endothelial progenitor cell mobilization in diabetic patients with foot infection or skin 
defects. Experimental & molecular medicine 2013;45:e62. 
17. 
Xia CY, Yu AX, Qi B, Zhou M, Li ZH, Wang WY. Analysis of blood flow and local 
expression of angiogenesisassociated growth factors in infected wounds treated with negative 
pressure wound therapy. Molecular medicine reports 2014;9:1749-54. 
18. 
Chen SZ, Li J, Li XY, Xu LS. Effects of vacuum-assisted closure on wound 
microcirculation: an experimental study. Asian journal of surgery / Asian Surgical Association 
2005;28:211-7. 
19. 
Gouttefangeas C, Eberle M, Ruck P, et al. Functional T lymphocytes infiltrate 
implanted polyvinyl alcohol foams during surgical wound closure therapy. Clinical and 
experimental immunology 2001;124:398-405. 
20. 
Malmsjo M, Gustafsson L, Lindstedt S, Gesslein B, Ingemansson R. The effects of 
variable, intermittent, and continuous negative pressure wound therapy, using foam or gauze, 
on wound contraction, granulation tissue formation, and ingrowth into the wound filler. Eplasty 
2012;12:e5. 
21. 
Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management 
with negative pressure wound therapy (CIM): biomechanics. Surgical innovation 2012;19:67-
75. 
22. 
Echebiri NC, McDoom MM, Aalto MM, Fauntleroy J, Nagappan N, Barnabei VM. 
Prophylactic use of negative pressure wound therapy after cesarean delivery. Obstetrics and 
gynecology 2015;125:299-307. 
23. Yu L, Kronen RJ, Simmon LE, Stoll CRT, Colditz GA, Tuuli MG. Prophylactic negative 
pressure wound therapy after cesarean is associated with reduced risk of surgical site 
infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Sep 23. 

 
Clinical Investigation Plan  
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25 
 
 
Version 1.0: 15 November 2019 
 
24. 
Dragu A, Schnurer S, Unglaub F, et al. Wide topical negative pressure wound dressing 
treatment for patients undergoing abdominal dermolipectomy following massive weight loss. 
Obesity surgery 2011;21:1781-6. 
25.Stevens DL, Bisno AL, Chambers HF, et al. Practice guidelines for the diagnosis and 
management of skin and soft tissue infections: 2014 update by the infectious diseases society 
of America. Clinical infectious diseases : an official publication of the Infectious Diseases 
Society of America 2014;59:147-59.