NCT02901613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

September 11, 2016

Last Update Submit

February 10, 2017

Conditions

Negative-pressure Wound TherapyMorbid ObesityCesarean SectionWound Infection

Outcome Measures

Primary Outcomes (1)

  • Wound complication

    3 months

Study Arms (2)

Retrospective

NO INTERVENTION

Standard dry sterile dressing

Prospective

EXPERIMENTAL

Negative-pressure wound therapy

Device: Negative-pressure wound therapy

Interventions

Negative-pressure wound therapyDEVICE
Prospective

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Current BMI less than 40
  • current skin or soft tissue infection
  • skin or soft tissue disorder
  • allergy to silver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidWound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Peter Cole, MD

    Albany Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Denefrio, MD

CONTACT

5182645026denefrc@mail.amc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Gynecology

Study Record Dates

First Submitted

September 11, 2016

First Posted

September 15, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

US(1)