Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060170) titled 'Superirotiy randomized clinical trial of surigical site infection after pancreaticoduodenectomy:Negative pressure wound therapy vs. conventional wound dressing' on Jan. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Iwate Medical Univerisity
Condition:
Condition - Patients with any diseases reqiring pancreaticoduodenectomy, and obtained written informed consent
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the role of NPWT for contribution to the reduction of SSI
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - NPWT 1 week after surgery
Interventions/Control_2 - Conventional wound dressing 48 hours after surgery
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with any diseases requiring pancreaticoduodenectomy
Obtained written informed consent
Key exclusion criteria - Disagree with participating in this study
Allergy with dressing materials
Target Size - 79
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 12 Month 20 Day
Date of IRB - 2025 Year 12 Month 20 Day
Anticipated trial start date - 2026 Year 01 Month 05 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068816
Disclaimer: Curated by HT Syndication.
