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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 in gastrointestinal surgery: a multicenter randomized controlled trial - Investigation of the usefulness of a novel skin-closing device.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048169
Enrollment
100
Registered
2022-07-01
Start date
2022-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant or benign diseases of the digestive system requiring an open abdominal wound of 4 cm or greater

Interventions

Skin closure with Zipline Skin closure with interrupted 4-0 monofilament absorbalbe suture.

Sponsors

International University of Health and Welfare.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Exclude cases that fall into any of the following categories (1)Emergency surgery (2)Pregnancy (3)Cases with serious infections.

Design outcomes

Primary

MeasureTime frame
The time required for skin closure

Secondary

MeasureTime frame
Incidence of complications (wound infection, wound dehiscence) within 1 month after surgery, and wound cosmesis 6 months after surgery

Countries

Japan

Contacts

Public ContactTakuya Minagawa

International University of Health and Welfare, School of Medicine Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery

minagawa@iuhw.ac.jp0476-35-5600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026