The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01450631
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Complications; Surgical Site Infection; Surgical Wound Infection	Device: Prevena™ Incision Management System (PIMS); Device: Standard-of-care Dressing	N/A

Detailed Description

This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevena™ 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: 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.; Other Names: Standard Dressing
Experimental: Prevena™ (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.	Device: Prevena™ 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.; Other Names: PIMS NPWT Negative Pressure Wound Therapy

Outcome Measures

Primary Outcome Measures

1. Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. [Post-op Day 42 (+/- 10 days) after Cesarean section surgery]

   Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: Unanticipated local inflammatory response Prolonged drainage Fluid collection Dehiscence Surgical site infection (SSI)

Secondary Outcome Measures

1. Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. [Post-op Day: 42 (+/- 10 days) after Cesarean section surgery]

   Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include: Antimicrobials for surgical site infection Surgical drainage of the incision Surgical incision packing Adjunctive negative pressure therapy Debridement Re-operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

The Subject:

1. is a female aged ≥ 18 years

2. is able to provide her own informed consent

3. will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days

4. will require a surgical incision able to be covered completely by the PIMS skin interface

5. has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery

6. is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:

7. 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 -

1. 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

2. is willing and able to return for all scheduled and required study visits

3. is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site

Exclusion Criteria:

The Subject:

1. is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System)

2. has a systemic bacterial or fungal infection at the time of surgery

3. has a remote-site skin infection at the time of surgery

4. has a life expectancy of < 12 months

5. is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:

6. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract

• OR -

1. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera

2. 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

3. 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

4. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: Robert Heine, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT01450631
• Other Study ID Numbers: AHS.2011.Prevena.Heine.03
• First Posted: Oct 12, 2011
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by 3M: surgical site infection; nosocomial infection; post-operative complication; surgical incision risk; surgical incision infection; negative pressure wound therapy; wound management; cesarean section surgery; wound dehiscence; wound infection; surgical closure; wound disruption; subcutaneous approximation; wound separation; seroma; hematoma; subcutaneous closure; obesity; cesarean; incision; massive obesity; obese; pregnancy; cesarean delivery; superobesity; wound complication
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Postoperative Complications; Surgical Wound

Study Results

Participant Flow

Recruitment Details	Subjects for the study were recruited from a hospital Labor and Delivery Unit. Recruitment period: 26JAN2012 (site initiation) - 17DEC2013 (LPO)

Arm/Group Title	Standard Dressing	Prevena™ (PIMS)
Arm/Group Description	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.	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. Prevena™ 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.
Period Title: Overall Study
STARTED	46	46
COMPLETED	43	42
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Standard Dressing	Prevena™ (PIMS)	Total
Arm/Group Description	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.	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. Prevena™ 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.	Total of all reporting groups
Overall Participants	46	46	92
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.67 (4.953)	30.35 (5.724)	30.01 (5.334)
Sex: Female, Male (Count of Participants)
Female	46 100%	46 100%	92 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.2%	0 0%	1 1.1%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	35 76.1%	29 63%	64 69.6%
White	10 21.7%	17 37%	27 29.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.3%	3 6.5%	5 5.4%
Not Hispanic or Latino	44 95.7%	43 93.5%	87 94.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	46 100%	46 100%	92 100%
BMI (kg/m2) (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	46.79 (5.608)	46.25 (7.319)	46.52 (6.489)
Gestational Age (weeks) (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	37.87 (1.976)	38.08 (1.983)	37.97 (1.972)

Outcome Measures

1. Primary Outcome

Title	Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Description	Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: Unanticipated local inflammatory response Prolonged drainage Fluid collection Dehiscence Surgical site infection (SSI)
Time Frame	Post-op Day 42 (+/- 10 days) after Cesarean section surgery

Outcome Measure Data

Analysis Population Description

The Per-protocol Population was used for primary and secondary endpoint analysis.

Arm/Group Title	Standard Dressing	Prevena™ (PIMS)
Arm/Group Description	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.	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. Prevena™ 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.
Measure Participants	43	39
Number [participants]	7 15.2%	2 4.3%

2. Secondary Outcome

Title	Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Description	Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include: Antimicrobials for surgical site infection Surgical drainage of the incision Surgical incision packing Adjunctive negative pressure therapy Debridement Re-operation
Time Frame	Post-op Day: 42 (+/- 10 days) after Cesarean section surgery

Outcome Measure Data

Analysis Population Description

The Per-protocol Population was used for primary and secondary endpoint analysis.

Arm/Group Title	Standard Dressing	Prevena™ (PIMS)
Arm/Group Description	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.	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. Prevena™ 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.
Measure Participants	43	39
Number [participants]	6 13%	1 2.2%

Adverse Events

Time Frame	1 year 10 months
Arm/Group Title	Standard Dressing		Prevena™ (PIMS)
Arm/Group Description	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.		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. Prevena™ 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.
All Cause Mortality
	Standard Dressing		Prevena™ (PIMS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Dressing		Prevena™ (PIMS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/46 (4.3%)		4/46 (8.7%)
Cardiac disorders
Cardiomyopathy	0/46 (0%)		1/46 (2.2%)
Gastrointestinal disorders
Gastric Ulcer Perforation	0/46 (0%)		1/46 (2.2%)
Infections and infestations
Endometritis	1/46 (2.2%)		1/46 (2.2%)
Pneumonia	0/46 (0%)		1/46 (2.2%)
Injury, poisoning and procedural complications
Seroma	1/46 (2.2%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Standard Dressing		Prevena™ (PIMS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/46 (19.6%)		12/46 (26.1%)
Blood and lymphatic system disorders
Anaemia	0/46 (0%)		1/46 (2.2%)
Gastrointestinal disorders
Abdominal Pain	0/46 (0%)		1/46 (2.2%)
Constipation	1/46 (2.2%)		1/46 (2.2%)
Vomiting	0/46 (0%)		1/46 (2.2%)
Infections and infestations
Abscess	1/46 (2.2%)		0/46 (0%)
Celluitis	1/46 (2.2%)		0/46 (0%)
Fungal Infection	0/46 (0%)		1/46 (2.2%)
Gastroenteritis Viral	1/46 (2.2%)		0/46 (0%)
Intertrigo Candida	0/46 (0%)		2/46 (4.3%)
Mastitis	0/46 (0%)		1/46 (2.2%)
Postoperative Infection	3/46 (6.5%)		1/46 (2.2%)
Injury, poisoning and procedural complications
Blister	0/46 (0%)		3/46 (6.5%)
Seroma	2/46 (4.3%)		1/46 (2.2%)
Wound Dehiscence	5/46 (10.9%)		1/46 (2.2%)
Renal and urinary disorders
Dysuria	1/46 (2.2%)		1/46 (2.2%)
Pollakiuria	1/46 (2.2%)		0/46 (0%)
Skin and subcutaneous tissue disorders
Ecchymosis	1/46 (2.2%)		1/46 (2.2%)
Erythema	0/46 (0%)		1/46 (2.2%)
Puritus	0/46 (0%)		1/46 (2.2%)
Vascular disorders
Haematoma	1/46 (2.2%)		0/46 (0%)
Hypertension	3/46 (6.5%)		3/46 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.