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

This study is currently recruiting participants.
Verified May 2013 by KCI USA, Inc.
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT01450631
First received: October 10, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Post-operative Complications
Surgical Site Infection
Surgical Wound Infection
 Device: Prevena™ Incision Management System (PIMS)
Device: Standard-of-care Dressing
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by KCI USA, Inc.:

Primary Outcome Measures:
  • Change from baseline in Surgical Site Occurrences (SSOs) [ Time Frame: Post-op Days: 1, 2, 6, 14, and 42 ] [ Designated as safety issue: Yes ]

    Number of Subjects who experience SSOs. SSOs include:

    • Unanticipated local inflammatory response
    • Prolonged drainage
    • Fluid collection
    • Dehiscence
    • Surgical site infection (SSI)


Secondary Outcome Measures:
  • Change from baseline in Surgical Incision Interventions [ Time Frame: Post-op Days: 1, 2, 6, 14, and 42 ] [ Designated as safety issue: Yes ]

    Number of Subjects who have surgical incision interventions. Interventions include:

    • Surgical drainage of the incision
    • Surgical incision packing
    • Adjunctive negative pressure therapy
    • Debridement
    • Re-operation


Estimated Enrollment: 92
Study Start Date: February 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

    1. 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 -

    2. 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
  7. is willing and able to return for all scheduled and required study visits
  8. 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 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:

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

      - OR -

    2. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
  6. 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
  7. 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
  8. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450631

Contacts
Contact: Bonnie Thiele 919-681-5220 bonnie.thiele@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Robert Heine, MD     919-681-5220     robert.heine@dm.duke.edu    
Contact: Geeta Swamy, MD     919-681-5220     geeta.swamy@duke.edu    
Principal Investigator: Robert Heine, MD            
Sub-Investigator: Geeta Swamy, MD            
Sponsors and Collaborators
KCI USA, Inc.
Investigators
Study Director: Brett Gilmore, JD, MSHS, BSN, RN KCI USA, Inc.
Principal Investigator: Robert Heine, MD Duke University
  More Information

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
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by KCI USA, Inc.:
hematoma
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
subcutaneous closure
obesity
cesarean
incision
massive obesity
obese
pregnancy
cesarean delivery
superobesity
wound complication

Additional relevant MeSH terms:
Postoperative Complications
Surgical Wound Infection
Wound Infection
 Pathologic Processes
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013