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Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients

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ClinicalTrials.gov Identifier: NCT02901613
Recruitment Status : Unknown
Verified February 2017 by Peter R Cole, MD, Albany Medical College.
Recruitment status was:  Recruiting
First Posted : September 15, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Peter R Cole, MD, Albany Medical College

Study Description
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Brief Summary:
To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical Center Hospital. Retrospective data will be collected regarding morbidly obese patients who have undergone cesarean section and patients will be recruited to have the intervention (negative-pressure wound therapy) applied and outcomes will be evaluated.

Condition or disease Intervention/treatment Phase
Negative-pressure Wound Therapy Morbid Obesity Cesarean Section Wound Infection Device: Negative-pressure wound therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Retrospective
Standard dry sterile dressing
Experimental: Prospective
Negative-pressure wound therapy
 Device: Negative-pressure wound therapy


Outcome Measures
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Primary Outcome Measures :
  1. Wound complication [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women undergoing cesarean section at Albany Medical Center Hospital
  • Current BMI greater than or equal to 40

Exclusion Criteria:

  • Current BMI less than 40
  • current skin or soft tissue infection
  • skin or soft tissue disorder
  • allergy to silver
Contacts and Locations
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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): NCT02901613


Contacts
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Contact: Cassandra Denefrio, MD 5182645026 denefrc@mail.amc.edu

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Peter R Cole, MD    518-264-5026    colep@mail.amc.edu   
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Peter Cole, MD Albany Medical College
More Information
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Responsible Party: Peter R Cole, MD, Chief of Gynecology, Albany Medical College
ClinicalTrials.gov Identifier: NCT02901613     History of Changes
Other Study ID Numbers: AlbanyMC1
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Wound Infection
Obesity, Morbid
Wounds and Injuries
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Infection