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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT02373956
• Date of registration: 23/02/2015
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers MeliCare
• Scientific 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
• Date of first enrolment: November 20, 2015
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02373956
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Jean-Philippe Lavigne, MD, PhD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pressure Ulcer

Intervention(s)

Device: MELECTIS G

Procedure: Usual care

Primary Outcome(s)

Change in wound surface area according to the Gilman formula [Time Frame: Week 12]

Secondary Outcome(s)

Acceptability of the dressing by the medical staff [Time Frame: Week 12]

Appearance of the pressure ulcer [Time Frame: Week 2]

Algo plus scale [Time Frame: Week 12]

Diversity (Shannon's H) of bacteria species 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]

Presence/absence of adverse events [Time Frame: Week 1]

Relative variation (%) in wound surface area [Time Frame: At treatment stopping if appropriate (before week 12)]

Diversity (Shannon's H) of bacteria species present in the wound [Time Frame: Day 84]

Has the wound surface area reduced by at least 40%? yes/no [Time Frame: At treatment stopping if appropriate (before week 12)]

Relative variation (%) in wound surface area [Time Frame: Week 4]

The number of multiresistant bacteria species present in the wound [Time Frame: Baseline (Day 0)]

Has the wound surface area reduced by at least 40%? yes/no [Time Frame: Week 2]

Number of bacteria functional groups present in the wound [Time Frame: Day 84]

Presence/absence of adverse events [Time Frame: At treatment stopping if appropriate (before week 12)]

Relative variation (%) in wound surface area [Time Frame: Week 1]

Acceptability of the dressing by the medical staff [Time Frame: Week 1]

Algo plus scale [Time Frame: Week 1]

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]

Acceptability of the dressing by the medical staff [Time Frame: Week 2]

Algo plus scale [Time Frame: Baseline (Day 0)]

Algo plus scale [Time Frame: Week 8]

Appearance of the pressure ulcer [Time Frame: Week 4]

Acceptability of the dressing by the medical staff [Time Frame: At treatment stopping if appropriate (before week 12)]

Acceptability of the dressing by the medical staff [Time Frame: Week 4]

Appearance of the pressure ulcer [Time Frame: Week 12]

Appearance of the pressure ulcer [Time Frame: Week 8]

Acceptability of the dressing by the medical staff [Time Frame: Week 8]

Algo plus scale [Time Frame: Week 2]

Appearance of the pressure ulcer [Time Frame: Baseline (Day 0)]

Appearance of the pressure ulcer [Time Frame: Week 1]

Change in wound surface area according to the Gilman formula [Time Frame: Week 2]

Number of bacteria functional groups present in the wound [Time Frame: Baseline (Day 0)]

Algo plus scale [Time Frame: At treatment stopping if appropriate (before week 12)]

Algo plus scale [Time Frame: Week 4]

Presence/absence of adverse events [Time Frame: Week 4]

Relative variation (%) in wound depth [Time Frame: Week 12]

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 8]

Change in wound surface area according to the Gilman formula [Time Frame: At treatment stopping if appropriate (before week 12)]

Diversity (Shannon's H) of bacteria functional groups present in the wound [Time Frame: Baseline (Day 0)]

Diversity (Shannon's H) of bacteria species present in the wound [Time Frame: Day 14]

Has the wound surface area reduced by at least 40%? yes/no [Time Frame: Week 4]

Number of bacteria species present in the wound [Time Frame: Day 84]

Relative variation (%) in wound depth [Time Frame: At treatment stopping if appropriate (before week 12)]

Relative variation (%) in wound depth [Time Frame: Week 8]

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]

Relative variation (%) in wound depth [Time Frame: Week 1]

the ratio of the number of commensal over the total number of bacteria species present in the wound [Time Frame: Day 84]

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)]

Change in wound surface area according to the Gilman formula [Time Frame: Week 12]

Has the wound surface area reduced by at least 40%? yes/no [Time Frame: Week 12]

Number of bacteria species present in the wound [Time Frame: Baseline (Day 0)]

Relative variation (%) in wound depth [Time Frame: Week 2]

Presence/absence of adverse events [Time Frame: Week 12]

Presence/absence of adverse events [Time Frame: Week 8]

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)]

the ratio of the number of commensal over the total number of bacteria species present in the wound [Time Frame: Baseline (Day 0)]

Relative variation (%) in wound surface area [Time Frame: Week 12]

The number of multiresistant bacteria species present in the wound [Time Frame: Day 14]

The time to healing (days) [Time Frame: Week 12]

Appearance of the pressure ulcer [Time Frame: At treatment stopping if appropriate (before week 12)]

Change in wound surface area according to the Gilman formula [Time Frame: Week 4]

Has the wound surface area reduced by at least 40%? yes/no [Time Frame: Week 8]

Is the wound completely healed? yes/no [Time Frame: Week 12]

Number of bacteria functional groups present in the wound [Time Frame: Day 14]

Number of bacteria species present in the wound [Time Frame: Day 14]

Presence/absence of adverse events [Time Frame: Week 2]

Relative variation (%) in wound depth [Time Frame: Week 4]

Relative variation (%) in wound surface area [Time Frame: Week 2]

Relative variation (%) in wound surface area [Time Frame: Week 8]

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: Day 14]

Secondary ID(s)

2014-A01407-40

LOCAL/2014/JPL-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MELIPHARM SAS