Unique ID issued by UMIN | UMIN000048169 |
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Receipt number | R000053972 |
Scientific Title | Investigation of the usefulness of a novel skin-closing device in gastrointestinal surgery: a multicenter randomized controlled trial |
Date of disclosure of the study information | 2022/07/01 |
Last modified on | 2022/12/27 10:32:33 |
Investigation of the usefulness of a novel skin-closing device in gastrointestinal surgery: a multicenter randomized controlled trial
Investigation of the usefulness of a novel skin-closing device.
Investigation of the usefulness of a novel skin-closing device in gastrointestinal surgery: a multicenter randomized controlled trial
Investigation of the usefulness of a novel skin-closing device.
Japan |
Malignant or benign diseases of the digestive system requiring an open abdominal wound of 4 cm or greater
Surgery in general |
Malignancy
NO
In abdominal surgery, as in other fields, skin closure using the Zipline reduces postoperative SSI, is superior in cosmesis, and contributes to shorter operative time.
Safety,Efficacy
The time required for skin closure
Incidence of complications (wound infection, wound dehiscence) within 1 month after surgery, and wound cosmesis 6 months after surgery
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Maneuver |
Skin closure with Zipline
Skin closure with interrupted 4-0 monofilament absorbalbe suture.
20 | years-old | <= |
Not applicable |
Male and Female
Patients who meet all of the following eligibility criteria will be considered eligible
(1) Patients with malignant or benign diseases of the gastrointestinal system who undergo standby laparotomy with a laparotomy wound of 4 cm or larger.
(2) Patients must be at least 20 years of age at the time of consent.
(3) The patient himself/herself must be informed of the procedure using a written explanation and his/her written consent must be obtained.
Exclude cases that fall into any of the following categories
(1)Emergency surgery
(2)Pregnancy
(3)Cases with serious infections.
100
1st name | Osamu |
Middle name | |
Last name | Itano |
International University of Health and Welfare, School of Medicine
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
286-8520
852 Hatakeda, Narita, Chiba
0476-35-5600
itano@iuhw.ac.jp
1st name | Takuya |
Middle name | |
Last name | Minagawa |
International University of Health and Welfare, School of Medicine
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
286-8520
852 Hatakeda, Narita, Chiba
0476-35-5600
minagawa@iuhw.ac.jp
International University of Health and Welfare.
International University of Health and Welfare
Self funding
Institutional review board, International University of Health and Welfare
852 Hatakeda, Narita, Chiba
0476-35-5600
rinri_md@iuhw.ac.jp
NO
2022 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2022 | Year | 06 | Month | 24 | Day |
2022 | Year | 01 | Month | 24 | Day |
2022 | Year | 07 | Month | 01 | Day |
2024 | Year | 07 | Month | 01 | Day |
2022 | Year | 06 | Month | 26 | Day |
2022 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053972
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