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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT01450631
First received: October 10, 2011
Last updated: August 15, 2014
Last verified: August 2014
Results First Received: July 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Post-operative Complications
Surgical Site Infection
Surgical Wound Infection
Interventions: Device: Prevena™ Incision Management System (PIMS)
Device: Standard-of-care Dressing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects for the study were recruited from a hospital Labor and Delivery Unit. Recruitment period: 26JAN2012 (site initiation) - 17DEC2013 (LPO)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

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.


Participant Flow:   Overall Study
    Standard Dressing     Prevena™ (PIMS)  
STARTED     46     46  
COMPLETED     43     42  
NOT COMPLETED     3     4  
Lost to Follow-up                 2                 4  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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 Total of all reporting groups

Baseline Measures
    Standard Dressing     Prevena™ (PIMS)     Total  
Number of Participants  
[units: participants]
  46     46     92  
Age  
[units: years]
Mean ± Standard Deviation
  29.67  ± 4.953     30.35  ± 5.724     30.01  ± 5.334  
Gender  
[units: participants]
     
Female     46     46     92  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     35     29     64  
White     10     17     27  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     3     5  
Not Hispanic or Latino     44     43     87  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     46     46     92  
BMI (kg/m2)  
[units: kg/m2]
Mean ± Standard Deviation
  46.79  ± 5.608     46.25  ± 7.319     46.52  ± 6.489  
Gestational Age (weeks)  
[units: weeks]
Mean ± Standard Deviation
  37.87  ± 1.976     38.08  ± 1.983     37.97  ± 1.972  



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jill Twardowski, Director of Clinical Operations
Organization: KCI USA, Inc.
phone: 210-515-4166
e-mail: jill.twardowski@kci1.com


No publications provided


Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01450631     History of Changes
Other Study ID Numbers: AHS.2011.Prevena.Heine.03
Study First Received: October 10, 2011
Results First Received: July 3, 2014
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration