Pressure UlcerNPWTNCT03135964
The Study of Wound Dressings for Portable NPWT
A study testing filler dressing of NPWT in people with Pressure Ulcer and Diabetic Foot Ulcer, run by Tainan Municipal Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Ulcer, Diabetic Foot Ulcer
- What is being tested?
- filler dressing of NPWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- in-patient persons with the pressure ulcer or diabetic ulcer
Who cannot join
- Patient who has uncontrolled medical condition, such as sepsis, cellulitis
- Patient with diabetic ulcer who has severe PAOD untreated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Wound Dressings for Portable Negative Pressure Wound Therapy
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.
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer
- Being tested
- filler dressing of NPWT
- Keywords
- NPWT, foam, gauze
- Medical subject headings
- Pressure Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filler dressing of NPWTDevice
Also called KCI PU foam dressing, Kerlix AMD gauze
a dressing or filler material is used to fit to the contours of a wound (which is covered with a non-adherent dressing film) .
| Study group | Role | What they receive |
|---|---|---|
| foam | Active comparator | PU foam dressing from KCI Receives: Device: filler dressing of NPWT |
| gauze | Active comparator | Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien) Receives: Device: filler dressing of NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction rate of pressure ulcer size
Measured: up to 3weeks
Secondary outcomes (1)
The reduction rate of diabetic foot ulcer size
Measured: up to 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startFeb 2011
- Primary completionJan 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tainan Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao-Chin Yu, Master, Study director, Tainan Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135964
- Sponsor's protocol ID
- 990903
- Acronym
- NPWT
- Status last verified
- Apr 2017
- First submitted
- 4 Nov 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Wound Dressings for Portable Negative Pressure Wound Therapy
- ClinicalTrials.gov ID
- NCT03135964
- Acronym / sponsor ID
- NPWT / 990903
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer
- Keywords
- NPWT, foam, gauze
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Tainan Municipal HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| foam | Active comparator | Device: filler dressing of NPWTPU foam dressing from KCI |
| gauze | Active comparator | Device: filler dressing of NPWTPolyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- in-patient persons with the pressure ulcer or diabetic ulcer
Key exclusion criteria (2 listed)
- Patient who has uncontrolled medical condition, such as sepsis, cellulitis
- Patient with diabetic ulcer who has severe PAOD untreated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filler dressing of NPWTAlso: KCI PU foam dressing, Kerlix AMD gauzea dressing or filler material is used to fit to the contours of a wound (which is covered with a non-adherent dressing film) . | Device | foam, gauze |
Primary outcome
The reduction rate of pressure ulcer size
Time frame: up to 3weeks
1 secondary outcome
The reduction rate of diabetic foot ulcer size
Time frame: up to 3weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Chin Yu, Master study director
Tainan Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filler dressing of NPWT in people with Pressure Ulcer and Diabetic Foot Ulcer, run by Tainan Municipal Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction rate of pressure ulcer size (time frame: up to 3weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.