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drugset / Trial / NCT03865147

Single-centre Study to Investigate Safety and Efficacy of Tri-Solfen in Wound Debridement

NCT03865147 ↗

Phase 2 Unknown 90 enrolled Medical Ethics UK Ltd ProTherax Ltd · collabWelsh Wound Innovation Centre Ltd · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase IIa open, randomised, single and parallel group, therapy controlled, single centre study, which has been divided into 3 sequential phases, which are designed to study respectively, (a) the time taken to achieve surface anaesthesia, (b) the extent of post-operative pain relief and (c) the depth and quality of anaesthesia during a leg ulcer surgical debridement procedure

Timeline

Start
2019-01-15
Primary completion
2019-07-30
Completion
2019-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified — Topical
Subject Cetrimide Unknown — Topical
Subject EMLA Unknown 1 g Topical
Subject EMLA Unknown 2 g Topical
Subject Epinephrine Other / unclassified — Topical
Subject Lidocaine Other / unclassified — Topical
Background Acetaminophen Small molecule — —
Background Ibuprofen Small molecule — —

Indications

No indication recorded.