Trial Outcomes & Findings for Prevention of Seroma Formation and Wound Complications Using NPWT Devices (NCT NCT02147288)

Last Updated: 2017-01-30

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

Two weeks following drain removal

Results posted on

2017-01-30

Participant Flow

Patients were recruited for the "panniculectomy on negative pressure wound therapy (NPWT)" and "panniculectomy on Jackson-Pratt (JP) drains" groups. Patients were not recruited for the remaining arm;s the manufacturer, Smith \& Nephew, temporarily halted on the distribution of the device (Renasys\*GO negative pressure wound management system).

Participant milestones

Participant milestones
Measure	Panniculectomy on Jackson Pratt (JP) Drains Standard of Care	Panniculectomy on Negative Pressure Wound Therapy (NPWT) The Smith\&Nephew Renasys\GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm. Renasys\GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).
Overall Study STARTED	22	24
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Panniculectomy on Jackson Pratt (JP) Drains Standard of Care	Panniculectomy on Negative Pressure Wound Therapy (NPWT) The Smith\&Nephew Renasys\GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm. Renasys\GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).	Breast Recon With Acellular Dermal Matrix (ADM) on NPWT	Breast Recon With ADM on Jackson-Pratt (JP) Drains	Lipoabdominoplasty on NPWT	Lipoabdominoplasty on JP Drains	Abdominoplasty on NPWT	Abdominoplasty on JP Drains	Ventral Hernia Repair (VHR) on NPWT	Ventral Hernia Repair (VHR) on JP Drains
Overall Study post-operative hematoma	1	1	0	0	0	0	0	0	0	0
Overall Study complications from concurrent hernia rep	0	1	0	0	0	0	0	0	0	0

Baseline Characteristics

Prevention of Seroma Formation and Wound Complications Using NPWT Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panniculectomy on JP Drains n=21 Participants Standard of Care	Panniculectomy on NPWT n=22 Participants The Smith\&Nephew Renasys\GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm. Renasys\GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).	Total n=43 Participants Total of all reporting groups
Age, Continuous	41 years n=5 Participants	46 years n=7 Participants	43.6 years n=5 Participants
Gender Female	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Diabetes history diabetic	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Diabetes history non-diabetic	15 participants n=5 Participants	19 participants n=7 Participants	34 participants n=5 Participants
Smoking status smokers	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Smoking status non-smokers	18 participants n=5 Participants	18 participants n=7 Participants	36 participants n=5 Participants
Prior abdominal surgery yes	15 participants n=5 Participants	19 participants n=7 Participants	34 participants n=5 Participants
Prior abdominal surgery no	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Body mass Index	32.3 kg/m^2 n=5 Participants	30.4 kg/m^2 n=7 Participants	31.32 kg/m^2 n=5 Participants
Pre-operative prealbumin	20.3 milligrams per deciliter n=5 Participants	21.4 milligrams per deciliter n=7 Participants	20.9 milligrams per deciliter n=5 Participants
Incision length	52.3 centimeters n=5 Participants	56.6 centimeters n=7 Participants	54.5 centimeters n=5 Participants
Specimen weight	3.07 kilograms n=5 Participants	2.61 kilograms n=7 Participants	2.83 kilograms n=5 Participants
Drain duration	16 days n=5 Participants	14 days n=7 Participants	15 days n=5 Participants

PRIMARY outcome

Timeframe: Two weeks following drain removal

Population: Among 21 completers (standard of care group); one outlier was excluded from the analysis; 20 subjects were analyzed. Among 22 completers (experimental group), one outlier and 1 who did not have an ultrasound (i.e., fluid was not measured) were excluded, leaving 20 subjects for analysis.

Outcome measures

Outcome measures
Measure	Panniculectomy on JP Drains n=20 Participants Standard of Care	Panniculectomy on NPWT n=20 Participants The Smith\&Nephew Renasys\GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm. Renasys\GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).
Post-operative Seroma Formation	16.9 cm^3 Interval 0.0 to 132.0	10.1 cm^3 Interval 0.0 to 45.9

Adverse Events

Panniculectomy on JP Drains

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Panniculectomy on NPWT

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Panniculectomy on JP Drains n=22 participants at risk Standard of Care	Panniculectomy on NPWT n=24 participants at risk The Smith\&Nephew Renasys\GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm. Renasys\GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).
Skin and subcutaneous tissue disorders post-operative hematoma	4.5% 1/22 • Number of events 1	4.2% 1/24 • Number of events 1
Skin and subcutaneous tissue disorders abcess with infected mesh	0.00% 0/22	4.2% 1/24 • Number of events 1

Other adverse events

Other adverse events
Measure	Panniculectomy on JP Drains n=22 participants at risk Standard of Care	Panniculectomy on NPWT n=24 participants at risk The Smith\&Nephew Renasys\GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm. Renasys\GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).
Skin and subcutaneous tissue disorders seroma	18.2% 4/22 • Number of events 4	4.2% 1/24 • Number of events 1
Skin and subcutaneous tissue disorders wound dehiscence	18.2% 4/22 • Number of events 4	8.3% 2/24 • Number of events 2
Skin and subcutaneous tissue disorders cellulitis	9.1% 2/22 • Number of events 2	8.3% 2/24 • Number of events 2
Skin and subcutaneous tissue disorders stitch absess	0.00% 0/22	4.2% 1/24 • Number of events 1

Additional Information

Dr. Marc Walker

Yale University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place