NCT02534116

Brief Summary

The purpose of this study is to compare outcomes between incisional negative-pressure wound vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

August 13, 2015

Last Update Submit

January 11, 2018

Conditions

Abdominal Reconstruction

Keywords

abdominal reconstruction

Outcome Measures

Primary Outcomes (1)

  • Post Operative Wound Complications

    Post-operative wound complications (infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia) will be assessed at 2 days for gauze patients and at 5 days for VAC patients. This outcome will be assessed based on the clinical examination by the surgeon following removal of the wound dressing. There is no defined assessment tool for this outcome as clinical observation is the standard in these procedures.

    Between 2 and 5 days following surgery

Study Arms (2)

Vacuum-assisted closure (VAC) therapy

EXPERIMENTAL

Following closure of the incision, patients will have incisional vacuum-assisted closure (VAC) therapy performed.

Procedure: Vacuum-assisted closure (VAC) therapy

Gauze dressing

ACTIVE COMPARATOR

Following closure of the incision, patients will either have a gauze dressing placed over the incision.

Procedure: Gauze dressing

Interventions

Vacuum-assisted closure (VAC) therapyPROCEDURE

Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days.

Also known as: Negative-pressure wound therapy (NPWT)
Vacuum-assisted closure (VAC) therapy
Gauze dressingPROCEDURE

Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days.

Also known as: standard care
Gauze dressing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients included in this study are patients undergoing abdominal reconstruction, which includes panniculectomy, abdominoplasty, ventral hernia repair and patients undergoing autologous flap reconstruction using abdominal donor tissue.

You may not qualify if:

  • Patients will be excluded from study if they have an actively infected wound involving the incision, abdominal malignancy, a history of enteric fistula formation, or a bleeding disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University, Section of Plastic Surgery

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Negative-Pressure Wound TherapyTherapeuticsStandard of Care

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, OperativeWound Closure TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Sarah Persing, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 27, 2015

Study Start

December 1, 2015

Primary Completion

October 1, 2016

Study Completion

April 1, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

US(1)