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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: MELECTIS G; Procedure: Usual care

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Centre Mutualiste Neurologique Propara
  • Nîmes, France, 30029
    • CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Information provided on the implementation of the study, its objectives, constraints and patient rights
• The patient, or his/her legal guardian, must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 12 weeks of follow-up
• Presence of one or more pressure ulcers at stages 2, 3 or 4 according to the European Pressure Ulcer Advisory Panel - National Pressure Ulcer Advisory Panel (EPUAP-NPUAP) classification
• Wound whose surface is between 1 cm^2 and 15 cm^2
• Wound present for more than 6 weeks
• Patient whose wound requires a modern dressing (that is to say, a bandage that is neither tulle nor gauze) without bactericidal agents or antibiotics
• No antibiotics for at least 7 days prior to inclusion (after inclusion, the patient can be treated with antibiotics if necessary, regardless of the indications)

Exclusion Criteria:

• Patient participating in or having participated in another interventional study in the previous 3 months or currently in a patient exclusion period determined by a previous study.
• Patient under judicial protection
• Failure to correctly inform the patient or his/her legal representative
• Patient (or his/her legal guardian) refusal to sign the consent
• The patient is pregnant, parturient, or breastfeeding
• Contraindications (or incompatible combination therapy) for a necessary treatment in this study
• Patient with an allergy to honey or propolis
• The patient's general condition suggests study exclusion before twelve weeks of follow-up
• Antibiotics received within 7 days prior to inclusion
• Active neoplastic lesion treated with radiation or chemotherapy
• Immunosuppressive therapy or other treatment which, in the judgment of the investigator, may interfere with the healing process
• Surgery planned within twelve weeks of inclusion
• Stage 1 wound according to the EPUAP-NPUAP classification
• Amputation wound
• Wound related to a surgical treatment or for which an act of revascularization is envisaged within twelve weeks of inclusion
• Malignant wound

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MELECTIS G; In addition to usual care as described for the other arm, patients randomized to this arm will have MELECTIS G added to their wound dressing according to the manufacturer's instructions. Intervention: Usual care Intervention: MELECTIS G	Device: MELECTIS G; The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.
Active Comparator: Usual care; Patients randomized to this are will receive usual care according the current procedures at the Nîmes University Hospital (ICMD010 concerning pressure sore care and SCMD002 concerning referenced anti-pressure sore dressings). Intervention: Usual care	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 12
Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 1
Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 2
Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 4
Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 8
Change in wound surface area according to the Gilman formula	According to the Gilman formula	At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound surface area		Week 1
Relative variation (%) in wound surface area		Week 2
Relative variation (%) in wound surface area		Week 4
Relative variation (%) in wound surface area		Week 8
Relative variation (%) in wound surface area		Week 12
Relative variation (%) in wound surface area		At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound depth		Week 1
Relative variation (%) in wound depth		Week 2
Relative variation (%) in wound depth		Week 4
Relative variation (%) in wound depth		Week 8
Relative variation (%) in wound depth		Week 12
Relative variation (%) in wound depth		At treatment stopping if appropriate (before week 12)
Has the wound surface area reduced by at least 40%? yes/no		Week 2
Has the wound surface area reduced by at least 40%? yes/no		Week 4
Has the wound surface area reduced by at least 40%? yes/no		Week 8
Has the wound surface area reduced by at least 40%? yes/no		Week 12
Has the wound surface area reduced by at least 40%? yes/no		At treatment stopping if appropriate (before week 12)
Number of bacteria species present in the wound		Baseline (Day 0)
Number of bacteria species present in the wound		Day 14
Number of bacteria species present in the wound		Day 84
Diversity (Shannon's H) of bacteria species present in the wound		Baseline (Day 0)
Diversity (Shannon's H) of bacteria species present in the wound		Day 14
Diversity (Shannon's H) of bacteria species present in the wound		Day 84
Number of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Baseline (Day 0)
Number of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 14
Number of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 84
Diversity (Shannon's H) of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Baseline (Day 0)
Diversity (Shannon's H) of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 14
Diversity (Shannon's H) of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 84
The number of multiresistant bacteria species present in the wound		Baseline (Day 0)
The number of multiresistant bacteria species present in the wound		Day 14
The number of multiresistant bacteria species present in the wound		Day 84
the ratio of the number of commensal over the total number of bacteria species present in the wound		Baseline (Day 0)
the ratio of the number of commensal over the total number of bacteria species present in the wound		Day 14
the ratio of the number of commensal over the total number of bacteria species present in the wound		Day 84
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound		Baseline (Day 0)
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound		Day 14
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound		Day 84
Wound healing speed (change in cm^2 of surface area per week)		12 weeks (or maximum time span if total healing occurs before 12 weeks)
Is the wound completely healed? yes/no		Week 12
The time to healing (days)		Week 12
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Baseline (Day 0)
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 1
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 2
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 4
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 8
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 12
Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	At treatment stopping if appropriate (before week 12)
Presence/absence of adverse events		Week 1
Presence/absence of adverse events		Week 2
Presence/absence of adverse events		Week 4
Presence/absence of adverse events		Week 8
Presence/absence of adverse events		Week 12
Presence/absence of adverse events		At treatment stopping if appropriate (before week 12)
Algo plus scale		Baseline (Day 0)
Algo plus scale		Week 1
Algo plus scale		Week 2
Algo plus scale		Week 4
Algo plus scale		Week 8
Algo plus scale		Week 12
Algo plus scale		At treatment stopping if appropriate (before week 12)
Acceptability of the dressing by the medical staff	Acceptability of the dressing by the medical staff in relation to each of the following: Overall satisfaction; Easy installation; Ease of removal; conformability of the dressing to the wound; Pain at dressing change; Adhesion of dressing to the wound	Week 1
Acceptability of the dressing by the medical staff	Acceptability of the dressing by the medical staff in relation to each of the following: Overall satisfaction; Easy installation; Ease of removal; conformability of the dressing to the wound; Pain at dressing change; Adhesion of dressing to the wound	Week 2
Acceptability of the dressing by the medical staff	Acceptability of the dressing by the medical staff in relation to each of the following: Overall satisfaction; Easy installation; Ease of removal; conformability of the dressing to the wound; Pain at dressing change; Adhesion of dressing to the wound	Week 4
Acceptability of the dressing by the medical staff	Acceptability of the dressing by the medical staff in relation to each of the following: Overall satisfaction; Easy installation; Ease of removal; conformability of the dressing to the wound; Pain at dressing change; Adhesion of dressing to the wound	Week 8
Acceptability of the dressing by the medical staff	Acceptability of the dressing by the medical staff in relation to each of the following: Overall satisfaction; Easy installation; Ease of removal; conformability of the dressing to the wound; Pain at dressing change; Adhesion of dressing to the wound	Week 12
Acceptability of the dressing by the medical staff	Acceptability of the dressing by the medical staff in relation to each of the following: Overall satisfaction; Easy installation; Ease of removal; conformability of the dressing to the wound; Pain at dressing change; Adhesion of dressing to the wound	At treatment stopping if appropriate (before week 12)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: MELIPHARM SAS
• Investigators: Principal Investigator: Jean-Philippe Lavigne, MD, PhD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2015
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: LOCAL/2014/JPL-01; 2014-A01407-40 (Other Identifier: RCB number)