UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056337 |
|---|---|
| Receipt number | R000064366 |
| Scientific Title | Prevention of Skin Damage Using Disposable Retractors in Open Hepatobiliary Surgery: A Non-Randomized Controlled Trial Comparing Film Drapes and Sewn Gauze |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2026/06/03 14:21:32 |
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Basic information
Public title
Investigation of Skin Injury Prevention Methods Associated with Retractors in Open Surgery Under General Anesthesia
Acronym
Investigation of Skin Injury Prevention Methods
Scientific Title
Prevention of Skin Damage Using Disposable Retractors in Open Hepatobiliary Surgery: A Non-Randomized Controlled Trial Comparing Film Drapes and Sewn Gauze
Scientific Title:Acronym
Prevention of Skin Injury in Open Hepatobiliary and Pancreatic Surgery
Region
| Japan |
Condition
Condition
Skin Injury
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to compare two methods for preventing skin injury associated with the use of disposable retractors: applying film drapes to the abdomen and placing sewn gauze.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or Absence of Skin Injury at the Site of the Disposable Retractor After Surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Apply a film drape to the abdomen and position the disposable retractor.
Interventions/Control_2
Place sewn gauze between the disposable retractor and the skin.
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
1.Surgery
2.Hepatobiliary and Pancreatic Surgery
3.Open Surgery
4.Adult patients aged 20 years and older
5.General Anesthesia
6.All ASA Classification
7.No gender restriction
Key exclusion criteria
1.Emergency Surgery Patients
2.Other patients deemed inappropriate by the study investigator as research subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Reika |
| Middle name | |
| Last name | Tachibana |
Organization
NHO Nagasaki Medical Center
Division name
Department of Nursing
Zip code
856-8562
Address
2-1001-1 Kuhara, Omura City, Nagasaki Prefecture, Japan
TEL
0957-52-3121
tachibana.reika.mc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Reika |
| Middle name | |
| Last name | Tachibana |
Organization
NHO Nagasaki Medical Center
Division name
Department of Nursing
Zip code
856-8562
Address
2-1001-1 Kuhara, Omura City, Nagasaki Prefecture, Japan
TEL
0957-52-3121
Homepage URL
tachibana.reika.mc@mail.hosp.go.jp
Sponsor or person
Institute
Independent Administrative Institution NHO (Nagasaki Medical Center Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
SGH Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Nagasaki Medical Center
Address
2-1001-1 Kuhara, Omura City, Nagasaki Prefecture, Japan
Tel
0957-52-3121
tachibana.reika.mc@mail.hosp.go.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/329572-prevention-of-skin-damage-using-disposable-retractors-in-open
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/329572-prevention-of-skin-damage-using-disposable-retractors-in-open
Number of participants that the trial has enrolled
57
Results
Fifty-seven patients were analyzed. Operative time was shorter in the film drape group (p = 0.04), but retractor-related skin damage was more frequent than in the sewn gauze group (41.3% vs. 14.2%, p = 0.02). No postoperative pain was reported among patients with skin damage.
Results date posted
| 2026 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 57 patients undergoing open hepatobiliary surgery were included in the study (film drape group, n = 29; sewn gauze group, n = 28). There were no significant differences between the groups with respect to baseline characteristics, including age, sex, body mass index, diabetes status, and serum albumin levels.
Participant flow
A total of 57 patients were enrolled in the study. No patients were excluded or lost to follow-up, and no emergency surgeries were performed. All 57 patients were included in the final analysis (film drape group, n = 29; sewn gauze group, n = 28).
Adverse events
No serious adverse events related to the study intervention were observed. In addition, none of the patients who developed skin damage at the retractor-contact site reported postoperative pain.
Outcome measures
The primary outcome measure was the presence or absence of postoperative skin damage at the retractor-contact site. The secondary outcome measure was the presence or absence of postoperative pain at the retractor-contact site. Postoperative skin condition and pain were assessed and compared between the film drape group and the sewn gauze group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064366
