A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications

A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications - A randomized controlled trial to reducing wound complications

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002480

Enrollment

1060

Registered

2009-09-15

Start date

2009-06-01

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

Surgery for gastrointestinal diseases

Interventions

stapling skin-closure dermal skin-closure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) gastrointestinal surgery 2) 4,000/mm3=<WBC=<12,000 /mm3 Hb>=9.0 g/dL Plt>=100,000 / mm3 T.Bil=<1.5 mg/dL AST=<100 IU/L ALT=<100 IU/L Creatinin=<1.2 mg/dL Albumin>=2.8 g/dL 3) written informed consent.

Exclusion criteria

Exclusion criteria: 1) emergency 2) laparoscopic surgery 3) re-laparotomy 4) severe infections 5) bleeding tendency or coagulation disorders 6) uncontrolled diabetes mellitus 7) phsychic disorder 8) severe heart or lung diseases 9) continuous use of steroids

Design outcomes

Primary

Measure	Time frame
Occurrence of wound complications	—

Secondary

Measure	Time frame
Occurrence of keloid formation	—

Countries

Japan

Outcome results

None listed

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