NCT02399722

Brief Summary

In surgical units negative pressure wound therapy (NPWT) is often used to facilitate wound healing. The recommended frequency of change every third to fourth day causes an immense workload. The purpose of this study is to evaluate the effect of an additional polymeric membrane interface dressing (PolyMem® WIC) as primary wound contact layer in NPWT in comparison to NPWT alone on the number of required dressing changes until wound closure as the primary endpoint. Secondary endpoints are: time to heal and wound associated pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

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

Study Start

First participant enrolled

October 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

March 22, 2015

Last Update Submit

March 25, 2015

Conditions

Wound

Keywords

Negative Pressure Wound Therapy, polymeric membrane dressing, wounds

Outcome Measures

Primary Outcomes (1)

  • Number of dressing changes

    number of dressing changes until wound closure

    30 days

Secondary Outcomes (1)

  • Pain

    30 days

Study Arms (2)

VAC mono therapy

ACTIVE COMPARATOR

negative pressure wound therapy alone

Device: VAC mono therapy

WICVAC combined therapy

ACTIVE COMPARATOR

Polymeric membrane dressing combined with negative pressure wound therapy

Device: WICVAC

Interventions

WICVACDEVICE

combined wound therapy

Also known as: Polymeric membrane dressing (PolyMem® WIC)
WICVAC combined therapy
VAC mono therapyDEVICE

mono therapy

Also known as: NPWT (VAC)
VAC mono therapy

Eligibility Criteria

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

You may qualify if:

  • presence of a chronic wound or an infected wound with adequate perfusion
  • successful revascularization of underlying PAOD or diabetic macroangiopathy of lower extremities within 24-48 h before study allocation

You may not qualify if:

  • unfeasible or unsuccessful revascularization
  • preexisting documented allergies against used products
  • refusal of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Afshin Assadian, PD MD

    Department of Vascular and Endovascular Surgery - Wilhelminenhospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 22, 2015

First Posted

March 26, 2015

Study Start

October 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 26, 2015

Record last verified: 2015-03