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Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients

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ClinicalTrials.gov Identifier: NCT03082664
Recruitment Status : Unknown
Verified April 2018 by Meghan Hill, University of Arizona.
Recruitment status was:  Recruiting
First Posted : March 17, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Meghan Hill, University of Arizona

Tracking Information
First Submitted Date  ICMJE March 13, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date April 5, 2018
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
Wound complication [ Time Frame: post operative day 1-42 ]
wound breakdown, infection, separation, dehiscence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients
Official Title  ICMJE Topical Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Obstetric Patients
Brief Summary This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial. Each participant agreeing to study inclusion will be randomized to either suture alone or to closure of their skin incision with suture and then with prophylactic placement of a wound vac (PICO).
Detailed Description

Once consent has been obtained from patients, an envelope containing the study allocation will be retrieved from the Pyxis.

  • Non-wound vac patients will undergo wound closure with subcutaneous fat closure with Vicryl in all cases that this is practicable (in extremely thin patients, this may not be possible), followed by subcuticular skin closure also using Vicryl. A compression dressing will then be applied. This dressing is usually removed by the clinician the following day.
  • Wound vac (PICO) patients will undergo wound closure with subcutaneous fat closure with Vicryl in all cases that this is practicable (in extremely thin patients, this may not be possible), followed by subcuticular skin closure also using Vicryl. The wound vac system will then be applied over the closed incision. This vac dressing will then be removed on the day of hospital discharge and replaced with a second bandage and the wound vacuum will be re-activated. The patient will remove the bandage and discard on POD#7. This is per the manufacturer's guidelines for length of use.
  • If the patient fails the wound vac therapy- ie the wound separates and requires traditional wound care (packing, wet to dry dressing, etc), then the PICO system is no longer used as part of their care.

It would be unrealistic to try to standardize the entire operative approach (closure of the uterus, closure of the fascia) as the different providers working at the hospital may choose not to participate if the approach specified deviated too much from their usual technique. Different providers may typically use different kinds or sutures (made of different material, and of different sizes) or staples to close the subcutaneous fat and the skin. However, for this study all patients will have the subcutaneous fat and skin closed in the same manner (with Vicryl suture). To participate in the trial patients will have to agree to these closure materials. For this study a standard closure with suture was chosen as there is evidence suggesting a lower rate of wound complications with suture as compared to staples.

The wound will be re-assessed at their 2 week and 6 week post-op follow up visits. The patients will be assessed by a physician at their post-operative clinic visits. The physician/investigator will ask the patient if they have had any postoperative complications since their surgery and will be asked to detail any complications if they answer yes to this question. The investigators will also obtain permission to call the participants for a patient satisfaction questionnaire at 1 week post-op, and possibly 2 and 6 weeks if they have not presented for their post op/partum appointments or the questionnaire could not be obtained at their visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • High Risk Pregnancy
  • Cesarean Wound Disruption With Postnatal Complication
Intervention  ICMJE Device: PICO Single Use Negative Pressure Wound Therapy
The PICO device will be placed over the closed cesarean section incision.
Other Name: Smith & Nephew PICO patch
Study Arms  ICMJE
  • No Intervention: Standard dressing
    Standard dressing will be applied after C-section.
  • Experimental: PICO dressing
    Device: PICO Single Use Negative Pressure Wound Therapy
    Intervention: Device: PICO Single Use Negative Pressure Wound Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 13, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Maternal Age 18 or above
  2. Cesarean delivery
  3. Maternal condition which increases the risk of wound complication. These conditions include: Obesity (BMI >30), diabetes, HIV/AIDS, chorioamnionitis, rheumatologic disease, history of wound complication, anticoagulant therapy.
  4. Patient able to read and speak English or Spanish.

Exclusion Criteria:

  1. Minors (<18 years of age)
  2. Non-cesarean wound (ie tubal ligation wound)
  3. No high risk maternal condition
  4. Patient unable to read and speak English or Spanish.
  5. Prisoners
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03082664
Other Study ID Numbers  ICMJE 1412596588
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Meghan Hill, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meghan Hill, MBBS University of Arizona
PRS Account University of Arizona
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP