UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018448 |
|---|---|
| Receipt number | 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 11:53:55 |
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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
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
kfukuoka@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016976
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| Registered date | File name |
| Research case data | |
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