Pressure UlcerMeliCareNCT02373956
Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers
A study testing MELECTIS G in people with Pressure Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- MELECTIS G
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Nov 2015to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Mutualiste Neurologique Propara
Montpellier, 34090
CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Nîmes, 30029
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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
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.
Read the detailed description
The secondary objectives of this study are to compare the following items between the two arms of the study:
- 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
- Being tested
- MELECTIS G, Usual care
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELECTIS GDevice
The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.
Usual careProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| MELECTIS G | Experimental | 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 Receives: Device: MELECTIS G |
| Usual care | Active comparator | 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 Receives: Device: MELECTIS G; Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: Week 12
Secondary outcomes (73)
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: Week 1
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: Week 2
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: Week 4
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: Week 8
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: Week 12
Change in wound surface area according to the Gilman formula
According to the Gilman formula
Measured: At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound surface area
Measured: Week 1
Relative variation (%) in wound surface area
Measured: Week 2
Relative variation (%) in wound surface area
Measured: Week 4
Relative variation (%) in wound surface area
Measured: Week 8
Relative variation (%) in wound surface area
Measured: Week 12
Relative variation (%) in wound surface area
Measured: At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound depth
Measured: Week 1
Relative variation (%) in wound depth
Measured: Week 2
Relative variation (%) in wound depth
Measured: Week 4
Relative variation (%) in wound depth
Measured: Week 8
Relative variation (%) in wound depth
Measured: Week 12
Relative variation (%) in wound depth
Measured: At treatment stopping if appropriate (before week 12)
Has the wound surface area reduced by at least 40%? yes/no
Measured: Week 2
Has the wound surface area reduced by at least 40%? yes/no
Measured: Week 4
Has the wound surface area reduced by at least 40%? yes/no
Measured: Week 8
Has the wound surface area reduced by at least 40%? yes/no
Measured: Week 12
Has the wound surface area reduced by at least 40%? yes/no
Measured: At treatment stopping if appropriate (before week 12)
Number of bacteria species present in the wound
Measured: Baseline (Day 0)
Number of bacteria species present in the wound
Measured: Day 14
Number of bacteria species present in the wound
Measured: Day 84
Diversity (Shannon's H) of bacteria species present in the wound
Measured: Baseline (Day 0)
Diversity (Shannon's H) of bacteria species present in the wound
Measured: Day 14
Diversity (Shannon's H) of bacteria species present in the wound
Measured: Day 84
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Measured: Baseline (Day 0)
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Measured: Day 14
Number of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Measured: Day 84
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Measured: Baseline (Day 0)
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Measured: Day 14
Diversity (Shannon's H) of bacteria functional groups present in the wound
Functional groups: commensal, pathogenic, weak pathogenic potential
Measured: Day 84
The number of multiresistant bacteria species present in the wound
Measured: Baseline (Day 0)
The number of multiresistant bacteria species present in the wound
Measured: Day 14
The number of multiresistant bacteria species present in the wound
Measured: Day 84
the ratio of the number of commensal over the total number of bacteria species present in the wound
Measured: Baseline (Day 0)
the ratio of the number of commensal over the total number of bacteria species present in the wound
Measured: Day 14
the ratio of the number of commensal over the total number of bacteria species present in the wound
Measured: Day 84
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Measured: Baseline (Day 0)
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Measured: Day 14
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
Measured: Day 84
Wound healing speed (change in cm^2 of surface area per week)
Measured: 12 weeks (or maximum time span if total healing occurs before 12 weeks)
Is the wound completely healed? yes/no
Measured: Week 12
The time to healing (days)
Measured: Week 12
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: Baseline (Day 0)
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: Week 1
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: Week 2
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: Week 4
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: Week 8
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: Week 12
Appearance of the pressure ulcer
Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Measured: At treatment stopping if appropriate (before week 12)
Presence/absence of adverse events
Measured: Week 1
Presence/absence of adverse events
Measured: Week 2
Presence/absence of adverse events
Measured: Week 4
Presence/absence of adverse events
Measured: Week 8
Presence/absence of adverse events
Measured: Week 12
Presence/absence of adverse events
Measured: At treatment stopping if appropriate (before week 12)
Algo plus scale
Measured: Baseline (Day 0)
Algo plus scale
Measured: Week 1
Algo plus scale
Measured: Week 2
Algo plus scale
Measured: Week 4
Algo plus scale
Measured: Week 8
Algo plus scale
Measured: Week 12
Algo plus scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At treatment stopping if appropriate (before week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start20 Nov 2015
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: difficulties to include
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- MELIPHARM SAS
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lavigne, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373956
- Sponsor's protocol ID
- LOCAL/2014/JPL-01
- Other IDs
- 2014-A01407-40
- Acronym
- MeliCare
- Status last verified
- Aug 2021
- First submitted
- 23 Feb 2015
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02373956
- Acronym / sponsor ID
- MeliCare / LOCAL/2014/JPL-01
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties to include
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- MELIPHARM SAS
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MELECTIS G | Experimental | Device: MELECTIS GIn 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 |
| Usual care | Active comparator | Device: MELECTIS G, Procedure: Usual carePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MELECTIS GThe experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid. | Device | MELECTIS G, Usual care |
| Usual carePatients 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). | Procedure or surgery | Usual care |
Primary outcome
Change in wound surface area according to the Gilman formula
Time frame: Week 12
According to the Gilman formula
73 secondary outcomes
Change in wound surface area according to the Gilman formula
Time frame: Week 1
Change in wound surface area according to the Gilman formula
Time frame: Week 2
Change in wound surface area according to the Gilman formula
Time frame: Week 4
Change in wound surface area according to the Gilman formula
Time frame: Week 8
Change in wound surface area according to the Gilman formula
Time frame: Week 12
Change in wound surface area according to the Gilman formula
Time frame: At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound surface area
Time frame: Week 1
Relative variation (%) in wound surface area
Time frame: Week 2
Relative variation (%) in wound surface area
Time frame: Week 4
Relative variation (%) in wound surface area
Time frame: Week 8
Relative variation (%) in wound surface area
Time frame: Week 12
Relative variation (%) in wound surface area
Time frame: At treatment stopping if appropriate (before week 12)
Relative variation (%) in wound depth
Time frame: Week 1
Relative variation (%) in wound depth
Time frame: Week 2
Relative variation (%) in wound depth
Time frame: Week 4
Relative variation (%) in wound depth
Time frame: Week 8
Relative variation (%) in wound depth
Time frame: Week 12
Relative variation (%) in wound depth
Time frame: At treatment stopping if appropriate (before week 12)
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 2
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 4
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 8
Has the wound surface area reduced by at least 40%? yes/no
Time frame: Week 12
Has the wound surface area reduced by at least 40%? yes/no
Time frame: At treatment stopping if appropriate (before week 12)
Number of bacteria species present in the wound
Time frame: Baseline (Day 0)
Number of bacteria species present in the wound
Time frame: Day 14
Number of bacteria species present in the wound
Time frame: Day 84
Diversity (Shannon's H) of bacteria species present in the wound
Time frame: Baseline (Day 0)
Diversity (Shannon's H) of bacteria species present in the wound
Time frame: Day 14
Diversity (Shannon's H) of bacteria species present in the wound
Time frame: Day 84
Number of bacteria functional groups present in the wound
Time frame: Baseline (Day 0)
Number of bacteria functional groups present in the wound
Time frame: Day 14
Number of bacteria functional groups present in the wound
Time frame: Day 84
Diversity (Shannon's H) of bacteria functional groups present in the wound
Time frame: Baseline (Day 0)
Diversity (Shannon's H) of bacteria functional groups present in the wound
Time frame: Day 14
Diversity (Shannon's H) of bacteria functional groups present in the wound
Time frame: Day 84
The number of multiresistant bacteria species present in the wound
Time frame: Baseline (Day 0)
The number of multiresistant bacteria species present in the wound
Time frame: Day 14
The number of multiresistant bacteria species present in the wound
Time frame: Day 84
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time frame: Baseline (Day 0)
the ratio of the number of commensal over the total number of bacteria species present in the wound
Time frame: Day 14
Results and safety
The study was stopped early (reason given: difficulties to include). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Lavigne, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MELECTIS G in people with Pressure Ulcer, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulties to include). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wound surface area according to the Gilman formula (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.