The Study of Wound Dressings for Portable NPWT (NPWT)
Primary Purpose
Pressure Ulcer, Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
filler dressing of NPWT
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer focused on measuring NPWT, foam, gauze
Eligibility Criteria
Inclusion Criteria:
- in-patient persons with the pressure ulcer or diabetic ulcer
Exclusion Criteria:
- Patient who has uncontrolled medical condition, such as sepsis, cellulitis
- Patient with diabetic ulcer who has severe PAOD untreated
Sites / Locations
- Tainan Municipal Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
foam
gauze
Arm Description
PU foam dressing from KCI
Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien)
Outcomes
Primary Outcome Measures
The reduction rate of pressure ulcer size
Secondary Outcome Measures
The reduction rate of diabetic foot ulcer size
Full Information
NCT ID
NCT03135964
First Posted
November 4, 2015
Last Updated
April 26, 2017
Sponsor
Tainan Municipal Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03135964
Brief Title
The Study of Wound Dressings for Portable NPWT
Acronym
NPWT
Official Title
The Study of Wound Dressings for Portable Negative Pressure Wound Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tainan Municipal Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure, has become a popular therapy for the treatment of many acute and chronic wounds. In many randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU) foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers routinely used in negative pressure wound therapy, on the healing of the diabetic lower-extremity ulcers and the pressure ulcer.
Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups randomly. The letter of consent was signed by the patient or patient's family. After debridement of the infective wound, the wound of experimental group was packed with a moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each time of changing dressing in the following 3 weeks. The percentage of wound area reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were analyzed using linear mixed mode with SPSS statistical software. This clinical study was approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Diabetic Foot Ulcer
Keywords
NPWT, foam, gauze
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
foam
Arm Type
Active Comparator
Arm Description
PU foam dressing from KCI
Arm Title
gauze
Arm Type
Active Comparator
Arm Description
Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien)
Intervention Type
Device
Intervention Name(s)
filler dressing of NPWT
Other Intervention Name(s)
KCI PU foam dressing, Kerlix AMD gauze
Intervention Description
a dressing or filler material is used to fit to the contours of a wound (which is covered with a non-adherent dressing film) .
Primary Outcome Measure Information:
Title
The reduction rate of pressure ulcer size
Time Frame
up to 3weeks
Secondary Outcome Measure Information:
Title
The reduction rate of diabetic foot ulcer size
Time Frame
up to 3weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
in-patient persons with the pressure ulcer or diabetic ulcer
Exclusion Criteria:
Patient who has uncontrolled medical condition, such as sepsis, cellulitis
Patient with diabetic ulcer who has severe PAOD untreated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao-Chin Yu, Master
Organizational Affiliation
Tainan Municipal Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tainan Municipal Hospital
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
12. IPD Sharing Statement
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The Study of Wound Dressings for Portable NPWT
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