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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018448
Receipt No. R000016976
Scientific Title Effect of Subcutaneous Epinephrine/Saline/Local Anesthetic Versus Saline-Only Injection on Split-Thickness Skin Graft Donor Site
Date of disclosure of the study information 2015/08/01
Last modified on 2019/07/31

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Basic information
Public title Effect of Subcutaneous Epinephrine/Saline/Local Anesthetic Versus Saline-Only Injection on Split-Thickness Skin Graft Donor Site
Acronym Effect of Tumescent Technique on Split-Thickness Skin Graft Donor Site
Scientific Title Effect of Subcutaneous Epinephrine/Saline/Local Anesthetic Versus Saline-Only Injection on Split-Thickness Skin Graft Donor Site
Scientific Title:Acronym Effect of Tumescent Technique on Split-Thickness Skin Graft Donor Site
Region
Japan

Condition
Condition split-thickness skin graft donor site
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aims of this study is to evaluate the effect of tumescent injection on donor site healing, and pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Healing time
2.post operative pain
3.ulcer recurrence
4.existence of hypertrophic scar
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Use tumescent technique before harvesting skin graft
Interventions/Control_2 adrenaline application after graft harvesting
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1.No skin disease in donor sites
2.Can get informed consent
3.Age 20-85
4.Size of the donor sites over 20 cm2
Key exclusion criteria 1.Patients who do not conform inclusion criteria.
2.Decision by researchers
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Shunjiro
Middle name
Last name Yagi
Organization Tottori university hospital
Division name Department of plastic and reconstructive surgery
Zip code 6838504
Address 36-1 Nishi-chou, Yonago-shi,Tottori
TEL 0859-38-6711
Email toprsri@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Fukuoka
Organization Tottori university hospital
Division name Department of plastic and reconstructive surgery
Zip code 683804
Address 36-1 Nishi-chou, Yonago-shi,Tottori
TEL 0859-38-6711
Homepage URL
Email kfukuoka@med.tottori-u.ac.jp

Sponsor
Institute Tottori university hospital
Institute
Department

Funding Source
Organization Tottori university hospital Department of plastic and reconstructive surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tottori university hospital
Address 36-1 Nishi-chou, Yonago-shi,Tottori
Tel 0859-38-7155
Email toprsri@med.tottori-u.ac.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
2015 Year 08 Month 01 Day

Related information
URL releasing protocol unpublished
Publication of results Unpublished

Result
URL related to results and publications unpublished
Number of participants that the trial has enrolled 49
Results
Donor sites healed within an average of 14.8 days in group1 and 20.4 days in group2. 
The number of cases in which the donor sites healed within 14 days was 15 cases in group1 and 9 cases in group2.
Postoperative pain reported on day 1 was an average of 3.46/10 in group1 and 2.84/10 in group2. 
During the late follow-up period, ulceration on the healed site occurred in 9 cases in both groups. 
One hypertrophic scar formation was seen in group2. 
Results date posted
2019 Year 07 Month 31 Day
Results Delayed
Delay expected
Results Delay Reason now writing
Date of the first journal publication of results
Baseline Characteristics
patients admitted to Tottori university hospital and Shimane Prefectural central hospital between April 2013 and March 2016 with skin defects and planned a split skin graft harvest from thigh.
Participant flow
Before the operative procedure, informed consent was obtained from the study participants using a document showing details of the treatment and the clinical research. Registration numbers were given to each participant. They were randomly assigned to receive either Pre-harvest subcutaneous injection of local anesthetic, adrenaline and saline solution or Post-harvest application of adrenaline solution soaked gauze to the skin graft donor sites as hamostatic procedure. Those receiving pre-harvest subcutaneous injection were categorized as group1, and those receiving post-harvest topical adrenaline administration were categorized as group2.
Adverse events
one wound infection
Outcome measures
Donor site healing, post-operative pain, donor site ulceration, and scar quality were examined as outcome measures.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 21 Day
Date of IRB
2014 Year 05 Month 21 Day
Anticipated trial start date
2014 Year 05 Month 21 Day
Last follow-up date
2017 Year 07 Month 01 Day
Date of closure to data entry
2017 Year 08 Month 01 Day
Date trial data considered complete
2017 Year 08 Month 01 Day
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 28 Day
Last modified on
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016976

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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