MedTrace Logo

Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers

NCT02373956 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-08-09

No results posted yet for this study

Summary

The main objective of this study is to document the effectiveness of a honey-based medical device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical device will be judged according to the evolution of the surface of the wound at the end of 12 weeks of treatment.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

MELECTIS G

The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.

PROCEDURE

Usual care

Patients will receive usual care according to the current procedures at the Nîmes University Hospital (ICMD010 concerning pressure sore care and SCMD002 concerning referenced anti-pressure sore dressings).

Sponsors & Collaborators

  • MELIPHARM SAS

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Jean-Philippe Lavigne, MD, PhD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • France

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 NCT02373956 on ClinicalTrials.gov