UMIN ID: UMIN000002480
Registered date:15/09/2009
A randomized controlled trial comparing dermal skin-closure vs stapling skin-closure in gastrointestinal open surgery to reducing wound complications
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Surgery for gastrointestinal diseases |
| Date of first enrollment | 2009/06/01 |
| Target sample size | 1060 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | stapling skin-closure dermal skin-closure |
Outcome(s)
| Primary Outcome | Occurrence of wound complications |
|---|---|
| Secondary Outcome | Occurrence of keloid formation |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Multicenter Clinical Study Group of Osaka |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Multicenter Clinical Study Group of Osaka |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 06-6879-3251 |
| Affiliation | Osaka University Gastroentrological Surgery |
| scientific contact | |
| Name | Toshimasa Tsujinaka |
| Address | 2-1-14, Hoenzaka, Osaka City, Osaka , JAPAN Japan |
| Telephone | |
| Affiliation | Osaka National Hospital Surgery |