Back to resultsEfficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers (MeliCare)
Primary Purpose
Pressure Ulcer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MELECTIS G
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer
Eligibility Criteria
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
Sites / Locations
- Centre Mutualiste Neurologique Propara
- CHRU de Nîmes - Hôpital Universitaire Carémeau
- CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MELECTIS G
Usual care
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Secondary Outcome Measures
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Relative variation (%) in wound surface area
Relative variation (%) in wound surface area
Relative variation (%) in wound surface area
Relative variation (%) in wound surface area
Relative variation (%) in wound surface area
Relative variation (%) in wound surface area
Relative variation (%) in wound depth
Relative variation (%) in wound depth
Relative variation (%) in wound depth
Relative variation (%) in wound depth
Relative variation (%) in wound depth
Relative variation (%) in wound depth
Has the wound surface area reduced by at least 40%? yes/no
Has the wound surface area reduced by at least 40%? yes/no
Has the wound surface area reduced by at least 40%? yes/no
Has the wound surface area reduced by at least 40%? yes/no
Has the wound surface area reduced by at least 40%? yes/no
Number of bacteria species present in the wound
Number of bacteria species present in the wound
Number of bacteria species present in the wound
Diversity (Shannon's H) of bacteria species present in the wound
Diversity (Shannon's H) of bacteria species present in the wound
Diversity (Shannon's H) of bacteria species present in the wound
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
The number of multiresistant bacteria species present in the wound
The number of multiresistant bacteria species present in the wound
The number of multiresistant bacteria species present in the wound
the ratio of the number of commensal over the total number of bacteria species present in the wound
the ratio of the number of commensal over the total number of bacteria species present in the wound
the ratio of the number of commensal over the total number of bacteria species present in the wound
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Wound healing speed (change in cm^2 of surface area per week)
Is the wound completely healed? yes/no
The time to healing (days)
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Presence/absence of adverse events
Presence/absence of adverse events
Presence/absence of adverse events
Presence/absence of adverse events
Presence/absence of adverse events
Presence/absence of adverse events
Algo plus scale
Algo plus scale
Algo plus scale
Algo plus scale
Algo plus scale
Algo plus scale
Algo plus scale
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
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
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
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
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
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
Full Information
NCT ID
NCT02373956
First Posted
February 23, 2015
Last Updated
August 3, 2021
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
MELIPHARM SAS
1. Study Identification
Unique Protocol Identification Number
NCT02373956
Brief Title
Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers
Acronym
MeliCare
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
difficulties to include
Study Start Date
November 20, 2015 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
MELIPHARM SAS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MELECTIS G
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MELECTIS G
Intervention Description
The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
Week 1
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
Week 2
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
Week 4
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
Week 8
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
Week 12
Title
Change in wound surface area according to the Gilman formula
Description
According to the Gilman formula
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Relative variation (%) in wound surface area
Time Frame
Week 1
Title
Relative variation (%) in wound surface area
Time Frame
Week 2
Title
Relative variation (%) in wound surface area
Time Frame
Week 4
Title
Relative variation (%) in wound surface area
Time Frame
Week 8
Title
Relative variation (%) in wound surface area
Time Frame
Week 12
Title
Relative variation (%) in wound surface area
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Relative variation (%) in wound depth
Time Frame
Week 1
Title
Relative variation (%) in wound depth
Time Frame
Week 2
Title
Relative variation (%) in wound depth
Time Frame
Week 4
Title
Relative variation (%) in wound depth
Time Frame
Week 8
Title
Relative variation (%) in wound depth
Time Frame
Week 12
Title
Relative variation (%) in wound depth
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Has the wound surface area reduced by at least 40%? yes/no
Time Frame
Week 2
Title
Has the wound surface area reduced by at least 40%? yes/no
Time Frame
Week 4
Title
Has the wound surface area reduced by at least 40%? yes/no
Time Frame
Week 8
Title
Has the wound surface area reduced by at least 40%? yes/no
Time Frame
Week 12
Title
Has the wound surface area reduced by at least 40%? yes/no
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Number of bacteria species present in the wound
Time Frame
Baseline (Day 0)
Title
Number of bacteria species present in the wound
Time Frame
Day 14
Title
Number of bacteria species present in the wound
Time Frame
Day 84
Title
Diversity (Shannon's H) of bacteria species present in the wound
Time Frame
Baseline (Day 0)
Title
Diversity (Shannon's H) of bacteria species present in the wound
Time Frame
Day 14
Title
Diversity (Shannon's H) of bacteria species present in the wound
Time Frame
Day 84
Title
Number of bacteria functional groups present in the wound
Description
Functional groups: commensal, pathogenic, weak pathogenic potential
Time Frame
Baseline (Day 0)
Title
Number of bacteria functional groups present in the wound
Description
Functional groups: commensal, pathogenic, weak pathogenic potential
Time Frame
Day 14
Title
Number of bacteria functional groups present in the wound
Description
Functional groups: commensal, pathogenic, weak pathogenic potential
Time Frame
Day 84
Title
Diversity (Shannon's H) of bacteria functional groups present in the wound
Description
Functional groups: commensal, pathogenic, weak pathogenic potential
Time Frame
Baseline (Day 0)
Title
Diversity (Shannon's H) of bacteria functional groups present in the wound
Description
Functional groups: commensal, pathogenic, weak pathogenic potential
Time Frame
Day 14
Title
Diversity (Shannon's H) of bacteria functional groups present in the wound
Description
Functional groups: commensal, pathogenic, weak pathogenic potential
Time Frame
Day 84
Title
The number of multiresistant bacteria species present in the wound
Time Frame
Baseline (Day 0)
Title
The number of multiresistant bacteria species present in the wound
Time Frame
Day 14
Title
The number of multiresistant bacteria species present in the wound
Time Frame
Day 84
Title
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time Frame
Baseline (Day 0)
Title
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time Frame
Day 14
Title
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time Frame
Day 84
Title
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Time Frame
Baseline (Day 0)
Title
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Time Frame
Day 14
Title
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Time Frame
Day 84
Title
Wound healing speed (change in cm^2 of surface area per week)
Time Frame
12 weeks (or maximum time span if total healing occurs before 12 weeks)
Title
Is the wound completely healed? yes/no
Time Frame
Week 12
Title
The time to healing (days)
Time Frame
Week 12
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Baseline (Day 0)
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Week 1
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Week 2
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Week 4
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Week 8
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
Week 12
Title
Appearance of the pressure ulcer
Description
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Presence/absence of adverse events
Time Frame
Week 1
Title
Presence/absence of adverse events
Time Frame
Week 2
Title
Presence/absence of adverse events
Time Frame
Week 4
Title
Presence/absence of adverse events
Time Frame
Week 8
Title
Presence/absence of adverse events
Time Frame
Week 12
Title
Presence/absence of adverse events
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Algo plus scale
Time Frame
Baseline (Day 0)
Title
Algo plus scale
Time Frame
Week 1
Title
Algo plus scale
Time Frame
Week 2
Title
Algo plus scale
Time Frame
Week 4
Title
Algo plus scale
Time Frame
Week 8
Title
Algo plus scale
Time Frame
Week 12
Title
Algo plus scale
Time Frame
At treatment stopping if appropriate (before week 12)
Title
Acceptability of the dressing by the medical staff
Description
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
Time Frame
Week 1
Title
Acceptability of the dressing by the medical staff
Description
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
Time Frame
Week 2
Title
Acceptability of the dressing by the medical staff
Description
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
Time Frame
Week 4
Title
Acceptability of the dressing by the medical staff
Description
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
Time Frame
Week 8
Title
Acceptability of the dressing by the medical staff
Description
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
Time Frame
Week 12
Title
Acceptability of the dressing by the medical staff
Description
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
Time Frame
At treatment stopping if appropriate (before week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Lavigne, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Mutualiste Neurologique Propara
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers
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