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The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevenaâ„¢ Incision Management System in women undergoing Cesarean section surgery.
This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevenaâ„¢ Incision Management System (PIMS) on Cesarean section Subjects compared to a control arm treated with a standard-of-care surgical incision dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PIMS on closed incisions. Clinical outcomes of interest for this study are defined as Surgical Site Occurrences (SSOs) that include unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, and surgical site infection (SSI). This investigation will compare these outcomes to a control group consisting of Subjects screened for the same inclusion and exclusion criteria but treated with a standard-of-care surgical incision dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dressing | Active Comparator | Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegadermâ„¢) consistent with the national standard for dressing Cesarean section incisions. |
|
| Prevenaâ„¢ (PIMS) | Experimental | PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenaâ„¢ Incision Management System (PIMS) | Device | PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:
| Post-op Day 42 (+/- 10 days) after Cesarean section surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:
|
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Inclusion Criteria:
The Subject:
is a female aged ≥ 18 years
is able to provide her own informed consent
will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days
will require a surgical incision able to be covered completely by the PIMS skin interface
has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery
is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered
- OR -
Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination
is willing and able to return for all scheduled and required study visits
is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site
Exclusion Criteria:
The Subject:
is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System)
has a systemic bacterial or fungal infection at the time of surgery
has a remote-site skin infection at the time of surgery
has a life expectancy of < 12 months
is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
- OR -
Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC) or other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration
who, in the investigator's opinion, would have any clinically significant condition that would impair the participant's ability to comply with the study procedures
has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
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| Name | Affiliation | Role |
|---|---|---|
| Robert Heine, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
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Subjects for the study were recruited from a hospital Labor and Delivery Unit. Recruitment period: 26JAN2012 (site initiation) - 17DEC2013 (LPO)
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dressing | Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions. Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy. |
| FG001 | Prevenaâ„¢ (PIMS) | PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. Prevenaâ„¢ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dressing | Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions. Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:
| The Per-protocol Population was used for primary and secondary endpoint analysis. | Posted | Number | participants | Post-op Day 42 (+/- 10 days) after Cesarean section surgery |
|
1 year 10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dressing | Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions. Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiomyopathy | Cardiac disorders | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Twardowski, Director of Clinical Operations | KCI USA, Inc. | 210-515-4166 | jill.twardowski@kci1.com |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D003428 | Cross Infection |
| D014946 | Wound Infection |
| D049291 | Seroma |
| D006406 | Hematoma |
| D009765 | Obesity |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
|
| Standard-of-care Dressing | Device | The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy. |
|
|
| Post-op Day: 42 (+/- 10 days) after Cesarean section surgery |
| BG001 | Prevenaâ„¢ (PIMS) | PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. Prevenaâ„¢ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Gestational Age (weeks) | Mean | Standard Deviation | weeks |
|
| OG001 | Prevenaâ„¢ (PIMS) | PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. Prevenaâ„¢ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. |
|
|
| Secondary | Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. | Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:
| The Per-protocol Population was used for primary and secondary endpoint analysis. | Posted | Number | participants | Post-op Day: 42 (+/- 10 days) after Cesarean section surgery |
|
|
|
| 2 |
| 46 |
| 9 |
| 46 |
| EG001 | Prevenaâ„¢ (PIMS) | PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. Prevenaâ„¢ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. | 4 | 46 | 12 | 46 |
| Gastric Ulcer Perforation | Gastrointestinal disorders | MedDRA 13.0 |
|
| Endometritis | Infections and infestations | MedDRA 13.0 |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.0 |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 |
|
| Abscess | Infections and infestations | MedDRA 13.0 |
|
| Celluitis | Infections and infestations | MedDRA 13.0 |
|
| Fungal Infection | Infections and infestations | MedDRA 13.0 |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA 13.0 |
|
| Intertrigo Candida | Infections and infestations | MedDRA 13.0 |
|
| Mastitis | Infections and infestations | MedDRA 13.0 |
|
| Postoperative Infection | Infections and infestations | MedDRA 13.0 |
|
| Blister | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 13.0 |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.0 |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
| Puritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
|
| Haematoma | Vascular disorders | MedDRA 13.0 |
|
| Hypertension | Vascular disorders | MedDRA 13.0 |
|
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| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D007249 | Inflammation |
| D006470 | Hemorrhage |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D014947 | Wounds and Injuries |