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Clinical Trials/ISRCTN15052559
ISRCTN15052559
Active, not recruiting
未知

A feasibility multicentre randomised controlled trial comparing Wide-awake Local Anaesthesia No Tourniquet (WALANT) versus General and Regional Anaesthesia (GA/RA) for Flexor Tendon Repair (WAFER Trial)

Royal Free London NHS Foundation Trust0 sites60 target enrollmentDecember 12, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Royal Free London NHS Foundation Trust
Enrollment
60
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37640464/ (added 29/08/2023)

Registry
who.int
Start Date
December 12, 2022
End Date
June 2, 2025
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Adults \>\=18 years old
  • 2\. Clinical diagnosis of acute flexor tendon injury (100% transected) involving Flexor digitorum profundus and/or Flexor digitorum superficialis, and/or Flexor pollicis longus of the hand
  • 3\. Single digit or two digits injury
  • 4\. Patient understands and is willing to participate and can comply with follow up regime

Exclusion Criteria

  • 1\. Tendon not amendable to primary repair (gross wound contamination, segmental tendon loss, associated fractures or mangled hand injuries)
  • 2\. Secondary tendon repair or reconstruction
  • 3\. History of allergy to Local anaesthetic (LA)
  • 4\. Refusal to have LA or deemed non\-cooperative to be performed without sedation
  • 5\. Pre\-existing deformity of finger or hand
  • 6\. High risk for GA or not fit for surgery (American society of anaesthesiologist grade \>4\)

Outcomes

Primary Outcomes

Not specified

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