Brief Summary

The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the effectiveness of standard closed-suction drains versus the immediate application of continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to non-compressible drains. Additionally, we aim to demonstrate increases both in cost-effectiveness and quality of life in these patients with the use of the NPWT wound care apparatus. Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound complications in comparison with conventional closed suction drains when used in patients after massive weight loss undergoing body-contouring procedures (panniculectomies alone and formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty. Hypothesis 2 Although initially more costly than traditional closed suction drains, the use of continuous negative pressure devices will in the long-term result in lower total health care costs in the above-stated patient population due to a decreased need for additional procedures and/or clinical management, including surgical interventions, hospital admissions, administration of antibiotics, multiple follow-up office visits, and chronic wound care. Hypothesis 3 Better quality of life is associated with the use of continuous negative pressure devices compared to closed suction drains in these patient populations.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

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

2.4 years study duration

Study Start

First participant enrolled

January 1, 2012

Completed

2.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed

6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

January 30, 2017

Completed

Last Updated

January 30, 2017

Status Verified

December 1, 2016

Enrollment Period

2.4 years

First QC Date

May 21, 2014

Results QC Date

August 11, 2016

Last Update Submit

December 6, 2016

Conditions

Seroma Wound Dehiscence Wound Infection

Outcome Measures

Primary Outcomes (1)

Post-operative Seroma Formation
Quantitative assessment of fluid collection in pre-defined anatomic regions will be performed via ultrasound examination approximately two weeks following removal of drains (either JP or NPWT-associated)
Two weeks following drain removal