UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023412 |
|---|---|
| Receipt number | R000026973 |
| Scientific Title | Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers using plastic wrap, polyethylene sheet, or non-adhesive dressing materials versus standard treatment |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2025/02/23 09:27:21 |
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Basic information
Public title
Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers using plastic wrap, polyethylene sheet, or non-adhesive dressing materials versus standard treatment
Acronym
Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers
Scientific Title
Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers using plastic wrap, polyethylene sheet, or non-adhesive dressing materials versus standard treatment
Scientific Title:Acronym
Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers
Region
| Japan |
Condition
Condition
pressure ulcer
Classification by specialty
| Surgery in general | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized controlled study is to compare the efficacy of non-occlusive and non-adhesive dressing treatment using plastic wrap, polyethylene sheet, or non-adhesive dressing material versus standard treatment conforming to guidelines for stage III/IV pressure ulcers (international NPUAP/EPUAP pressure ulcer classification system) in adult patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The absolute surface area reduction (SAR: baseline surface area - actual surface area). Whether the differences between the treatments will affect SAR for 12 weeks is investigated, and the SAR at 4, 8, and 12 week is compared for both treatments.
Key secondary outcomes
PSST score reduction at 4, 8, and 12 week compared to baseline (baseline PSST score - actual PSST score).
The incidence of adverse events including wound deterioration, local or systemic infection, hypergranulation, and maceration.
Required time to treat.
Required cost.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Stage III/IV pressure ulcers in the intervention group were treated with non-occlusive and non-adhesive dressing treatment using plastic wrap, polyethylene sheet, or non-adhesive dressing material.
Interventions/Control_2
Standard treatment conformed to treatment guideline published by NPUAP/EPUAP/PPPIA, and Japanese guideline issued by Japanese Society of Pressure Ulcers.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 or older with stage III/IV pressure ulcers according to international NPUAP/EPUAP pressure ulcer classification system were included. Eligible participants had pressure ulcers measuring 4 cm2 to 80 cm2 (from 2 to 4 in the item of Size on the Pressure Sore Status Tool [PSST] ), and the ulcers were in the yellow inflammatory phase; at least 50% of the surface area was covered by necrotic tissue (from 4 to 5 in the item of Necrotic tissue amount on the PSST). If a patient had multiple pressure ulcers, the largest one was selected for this study.
Written informed consent was obtained from participants or their family members.
Key exclusion criteria
Participants were excluded if their skin ulcer was due to other causes, including peripheral arterial occlusive disease, skin cancer; if they had poorly controlled diabetes (HbA1c > 10% measured at registration); or they were treated with corticosteroids, immunosuppressants, cytotoxic agents, or radiotherapy.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Takahashi |
Organization
Minakuchi Hospital
Division name
Department of Psychiatry
Zip code
528-0031
Address
2-2-43, Honmachi, Minakuchi-cho, Koka
TEL
+81-748-62-1212
taka-jun@zd.ztv.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Takahashi |
Organization
Minakuchi Hostpital
Division name
Department of Psychiatry
Zip code
528-0031
Address
2-2-43, Honmachi, Minakuchi-cho, Koka
TEL
+81-748-62-1212
Homepage URL
mail@minakuchi-hp.or.jp
Sponsor or person
Institute
Minakuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Minamikusatsu Keyaki Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Minakuchi Hospital Clinical Research Ethics Review Committee
Address
279 Nishitamazu-cho, Shimojuzuya-cho agaru, Ainomachidori Shimogyo section, Kyoto city
Tel
+81-75-344-6016
t.ando523@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
一般社団法人水口病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.minakuchi-hp.or.jp/pdf/protocol23412.pdf
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1089/wound.2024.0041
Number of participants that the trial has enrolled
77
Results
The SAR of the SOD group was greater than that of the OD group during the study period (P< 0.0001). At every assessment point, the BWAT score reduction of the SOD group was greater than that of the OD group, with a statistically significant difference observed at 12 weeks. The incidence of adverse events and number of deteriorated wounds with both treatments were approximately equal.The OD treatment cost was 3.0-times higher than the SOD treatment cost (P< 0.01).
Results date posted
| 2025 | Year | 02 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The baseline parameters included age, sex, mental disorders, systemic diseases (including infectious diseases, diabetes, and malignancy), hemoglobin level, body mass index, serum albumin level, Braden Scale score, location and surface area of the wound, and BWAT score. The two groups were well-balanced.
Participant flow
Eighty-six patients with deep skin ulcers were screened. Of those patients, 77 were enrolled and randomized to the SOD group (n = 40) or OD group (n = 37).
Adverse events
The incidence of adverse events including wound infection and maceration, the frequency of wound deterioration as assessed by SAR values or BWAT score were compared. No differences were found between the two groups.
Outcome measures
The primary outcome measure was the difference in absolute surface area reduction (SAR) of both treatment groups throughout the study period observed when the baseline surface area was compared with the surface area after treatment. The secondary outcomes included SAR values and BWAT score reductions comparison at 4, 8, and 12 weeks resulting from both treatments. Additionally, the incidence of adverse events including wound infection and maceration, the frequency of wound deterioration as assessed by SAR values or BWAT score, material cost, and frequency of dressing changes were compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026973
