Prophylactic Post-Cesarean Incisional Negative-pressure W... | NCT02901613

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

NCT02901613

Sponsor

Albany Medical College

Status

Unknown status

Last Update Posted

Feb 13, 2017Actual

Enrollment

186Estimated

Phase

Not Applicable

Conditions

Negative-pressure Wound Therapy
Morbid Obesity
Cesarean Section
Wound Infection

Interventions

Negative-pressure wound therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Sep 11, 2016

First Submission Date that Met QC Criteria

Sep 14, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2017

Last Update Posted Date

Feb 13, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrospective	No Intervention	Standard dry sterile dressing
Prospective	Experimental	Negative-pressure wound therapy	Device: Negative-pressure wound therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Negative-pressure wound therapy	Device		Prospective

Measure	Description	Time Frame
Wound complication		3 months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cassandra Denefrio, MD	Contact	5182645026		denefrc@mail.amc.edu

Overall Officials

Name	Affiliation	Role
Peter Cole, MD	Albany Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albany Medical Center	Recruiting	Albany	New York	12208	United States

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D014946	Wound Infection

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054843	Negative-Pressure Wound Therapy

Ancestor Terms

ID	Term
D004322	Drainage
D013812	Therapeutics
D013514	Surgical Procedures, Operative
D058106	Wound Closure Techniques

Browse Leaves

Not provided

Browse Branches

Not provided