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Trial record 1 of 1 for:    NCT03082664
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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 : Recruiting
First Posted : March 17, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Meghan Hill, University of Arizona

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).

Condition or disease Intervention/treatment Phase
High Risk Pregnancy Cesarean Wound Disruption With Postnatal Complication Device: PICO Single Use Negative Pressure Wound Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Topical Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Obstetric Patients
Actual Study Start Date : June 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard dressing
Standard dressing will be applied after C-section.
Experimental: PICO dressing
Device: PICO Single Use Negative Pressure Wound Therapy
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




Primary Outcome Measures :
  1. Wound complication [ Time Frame: post operative day 1-42 ]
    wound breakdown, infection, separation, dehiscence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082664


Contacts
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Contact: Meghan Hill, MBBS 5206266174 meghanhill@obgyn.arizona.edu
Contact: Destiny Dicken 5206265935 dlagrand@obgyn.arizona.edu

Locations
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United States, Arizona
Banner University Medical Center Tucson Recruiting
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Meghan Hill, MBBS University of Arizona

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Responsible Party: Meghan Hill, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT03082664     History of Changes
Other Study ID Numbers: 1412596588
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Wounds and Injuries