Combination of a Polymeric Membrane Dressing Plus Negative Pressure Wound Therapy Against Negative Pressure Wound Therapy Alone
Primary Purpose
Wound
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WICVAC
VAC mono therapy
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Negative Pressure Wound Therapy, polymeric membrane dressing, wounds
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- unfeasible or unsuccessful revascularization
- preexisting documented allergies against used products
- refusal of study participation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VAC mono therapy
WICVAC combined therapy
Arm Description
negative pressure wound therapy alone
Polymeric membrane dressing combined with negative pressure wound therapy
Outcomes
Primary Outcome Measures
Number of dressing changes
number of dressing changes until wound closure
Secondary Outcome Measures
Pain
pain during treatment
Full Information
NCT ID
NCT02399722
First Posted
March 22, 2015
Last Updated
March 25, 2015
Sponsor
Wilhelminenspital Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02399722
Brief Title
Combination of a Polymeric Membrane Dressing Plus Negative Pressure Wound Therapy Against Negative Pressure Wound Therapy Alone
Official Title
Prospective Randomized Trial Comparing the Combination of a Polymeric Membrane Dressing Plus Negative Pressure Wound Therapy Against Negative Pressure Wound Therapy Alone: The WICVAC Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilhelminenspital Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Background:
The treatment of chronic wounds requires time and resources. Optimized resource utilization in treatment of chronic wounds is of medical and economic interest.
Negative pressure wound therapy (NPWT) is widely used for the treatment of chronic wounds and surgical site infections. NPWT is indicated for the treatment of diabetic leg ulcers, lower leg ulcers as a result of peripheral arterial occlusive disease, pressure wounds, surgical incisional wounds, traumatic wounds, burns, infected wounds, necrotizing fasciitis, infected sternal wounds, and after skin grafting to facilitate healing. The polyurethane foam of the NPWT is directly applied to a wound bed and sealed with a transparent occlusive film prior to application of a negative pressure at 75 to 125 mmHg continuous suction. Prolonged placement of the foam in the wound bed results in tissue ingrowth. Then, removal of the foam becomes increasingly difficult and is often accompanied by pain, bleeding, and traumatization of the healing wound. Therefore, various efforts have been made to decrease wound tissue damage and pain during dressing change, including the use of different primary wound fillers, administration of topical analgesics or placement of various interface dressings. Yet, the effect of a non-adherent polymeric interface dressing on wearing time and frequency of dressing changes has not been studied.
Methods:
Sixty consecutive patients with chronic wounds of lower extremities or surgical site infections after revascularization are randomly allocated to either treatment with conventional negative pressure wound therapy (VAC arm, control) or negative pressure wound therapy with additional polymeric interface dressing (VAC + PolyMem® WIC, WICVAC, study arm). The polymeric membrane dressing is applied as direct wound contact layer, covered with the polyurethane foam dressing of the NPWT. The pink polymeric membrane dressing, which is left partially visible at the margin of the wound bed under the black polyurethane foam, serves as color indicator for the time-point of dressing change upon loss of the pink color. Patient characteristics, wound size at each dressing change, pain during treatment and the number of dressing changes needed until wound closure are documented.
Statistical analysis Sample size estimation was based on detecting a 20% difference in the number of dressing changes in favor of the WICVAC - study arm, with a type I error of 0.05 and type II error of 0.2. At least 23 patients are required for each study arm. Data are analyzed for statistical distribution. Due to skewed data distribution Mann-Whitney-U tests are applied for assessment of differences in primary and secondary endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
Negative Pressure Wound Therapy, polymeric membrane dressing, wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAC mono therapy
Arm Type
Active Comparator
Arm Description
negative pressure wound therapy alone
Arm Title
WICVAC combined therapy
Arm Type
Active Comparator
Arm Description
Polymeric membrane dressing combined with negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
WICVAC
Other Intervention Name(s)
Polymeric membrane dressing (PolyMem® WIC)
Intervention Description
combined wound therapy
Intervention Type
Device
Intervention Name(s)
VAC mono therapy
Other Intervention Name(s)
NPWT (VAC)
Intervention Description
mono therapy
Primary Outcome Measure Information:
Title
Number of dressing changes
Description
number of dressing changes until wound closure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pain
Description
pain during treatment
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
unfeasible or unsuccessful revascularization
preexisting documented allergies against used products
refusal of study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Assadian, PD MD
Organizational Affiliation
Department of Vascular and Endovascular Surgery - Wilhelminenhospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Combination of a Polymeric Membrane Dressing Plus Negative Pressure Wound Therapy Against Negative Pressure Wound Therapy Alone
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