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Clinical Trials/EUCTR2015-000232-15-ES
EUCTR2015-000232-15-ESActive, not recruitingPhase 1

Analgesic efficacy of levobupivacaine administered by wet wound dressing for the management split-thickness skin graft donor sites - HIDROGEL-014

Consorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor0 sitesStarted: July 15, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Patients> 18 and <= 75 years. 2. Patients had an split-thickness skin graft donor site area of 50?150 cm2. 3. Skin graft donor site anterior or
  • •posterior thigh. 4. Hospitalization of at least 72 hours. 5. Informed consent signed
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 36
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

  • •1. Rejection of the patient 2. Surgical procedure superior than 6hrs.3.Other conditions that warrant their inclusion as medically indicated: severe kidney illness (grade 3-4). severe hepatic illness (ChildPugh B and C grades), psychiatric illness), arrythmias, coagulation disorders, preganacy o lactation.
  • •4. Allergy to NSAIDs, local anesthetics and / or opioids. 5. Alcoholism. 6. Abuse drugs. 7. ASA III or higher 8. When the surgery procedure time is 1 hour
  • •more from the moment of obtention of the graft

Investigators

Sponsor
Consorcio Hospital General Universitario de Valencia . Servicio de Anestesia , Reanimacion y tto del Dolor

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