NCT02373956

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

Evaluation of the Efficacy and Tolerance of Honey-impregnated Dressings Versus Non-impregnated Dressings in the Local Management of Pressure Ulcers: A Randomized Single-blind Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The secondary objectives of this study are to compare the following items between the two arms of the study: A. The evolution of skin microbiota in the wound B. The evolution of the surface and the depth of the wound during follow-up C. The healing process D. Patient and caretaker acceptability

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-11-20
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2015-02-27
• Last updated: 2021-08-09

Locations

3 sites across 1 country: France