MedTrace Logo

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

NCT03865147 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-03-06

No results posted yet for this study

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

Conditions

  • Wounds Injuries
  • Anesthesia, Local

Interventions

DRUG

Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)

Investigational Drug

DRUG

EMLA cream

Active Comparator

DRUG

Post Operative Analgesia (Paracetamol, Ibuprofen)

Standard of Care

Sponsors & Collaborators

  • ProTherax Ltd

    collaborator UNKNOWN

  • Welsh Wound Innovation Centre Ltd

    collaborator UNKNOWN

  • Medical Ethics UK Ltd

    lead INDUSTRY

Principal Investigators

  • Keith Harding · Welsh Wound Innovation Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03865147 on ClinicalTrials.gov