Clinical trial NCT02373956: Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers
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
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: MELIPHARM SAS
First posted: 2015-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in wound surface area according to the Gilman formula
timeFrame: Week 12
Secondary outcomes:
measure: Change in wound surface area according to the Gilman formula
timeFrame: Week 1
measure: Change in wound surface area according to the Gilman formula
timeFrame: Week 2
measure: Change in wound surface area according to the Gilman formula
timeFrame: Week 4
measure: Change in wound surface area according to the Gilman formula
timeFrame: Week 8
measure: Change in wound surface area according to the Gilman formula
timeFrame: Week 12
measure: Change in wound surface area according to the Gilman formula
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Relative variation (%) in wound surface area
timeFrame: Week 1
measure: Relative variation (%) in wound surface area
timeFrame: Week 2
measure: Relative variation (%) in wound surface area
timeFrame: Week 4
measure: Relative variation (%) in wound surface area
timeFrame: Week 8
measure: Relative variation (%) in wound surface area
timeFrame: Week 12
measure: Relative variation (%) in wound surface area
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Relative variation (%) in wound depth
timeFrame: Week 1
measure: Relative variation (%) in wound depth
timeFrame: Week 2
measure: Relative variation (%) in wound depth
timeFrame: Week 4
measure: Relative variation (%) in wound depth
timeFrame: Week 8
measure: Relative variation (%) in wound depth
timeFrame: Week 12
measure: Relative variation (%) in wound depth
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Has the wound surface area reduced by at least 40%? yes/no
timeFrame: Week 2
measure: Has the wound surface area reduced by at least 40%? yes/no
timeFrame: Week 4
measure: Has the wound surface area reduced by at least 40%? yes/no
timeFrame: Week 8
measure: Has the wound surface area reduced by at least 40%? yes/no
timeFrame: Week 12
measure: Has the wound surface area reduced by at least 40%? yes/no
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Number of bacteria species present in the wound
timeFrame: Baseline (Day 0)
measure: Number of bacteria species present in the wound
timeFrame: Day 14
measure: Number of bacteria species present in the wound
timeFrame: Day 84
measure: Diversity (Shannon's H) of bacteria species present in the wound
timeFrame: Baseline (Day 0)
measure: Diversity (Shannon's H) of bacteria species present in the wound
timeFrame: Day 14
measure: Diversity (Shannon's H) of bacteria species present in the wound
timeFrame: Day 84
measure: Number of bacteria functional groups present in the wound
timeFrame: Baseline (Day 0)
measure: Number of bacteria functional groups present in the wound
timeFrame: Day 14
measure: Number of bacteria functional groups present in the wound
timeFrame: Day 84
measure: Diversity (Shannon's H) of bacteria functional groups present in the wound
timeFrame: Baseline (Day 0)
measure: Diversity (Shannon's H) of bacteria functional groups present in the wound
timeFrame: Day 14
measure: Diversity (Shannon's H) of bacteria functional groups present in the wound
timeFrame: Day 84
measure: The number of multiresistant bacteria species present in the wound
timeFrame: Baseline (Day 0)
measure: The number of multiresistant bacteria species present in the wound
timeFrame: Day 14
measure: The number of multiresistant bacteria species present in the wound
timeFrame: Day 84
measure: the ratio of the number of commensal over the total number of bacteria species present in the wound
timeFrame: Baseline (Day 0)
measure: the ratio of the number of commensal over the total number of bacteria species present in the wound
timeFrame: Day 14
measure: the ratio of the number of commensal over the total number of bacteria species present in the wound
timeFrame: Day 84
measure: the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
timeFrame: Baseline (Day 0)
measure: the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
timeFrame: Day 14
measure: the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound
timeFrame: Day 84
measure: Wound healing speed (change in cm^2 of surface area per week)
timeFrame: 12 weeks (or maximum time span if total healing occurs before 12 weeks)
measure: Is the wound completely healed? yes/no
timeFrame: Week 12
measure: The time to healing (days)
timeFrame: Week 12
measure: Appearance of the pressure ulcer
timeFrame: Baseline (Day 0)
measure: Appearance of the pressure ulcer
timeFrame: Week 1
measure: Appearance of the pressure ulcer
timeFrame: Week 2
measure: Appearance of the pressure ulcer
timeFrame: Week 4
measure: Appearance of the pressure ulcer
timeFrame: Week 8
measure: Appearance of the pressure ulcer
timeFrame: Week 12
measure: Appearance of the pressure ulcer
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Presence/absence of adverse events
timeFrame: Week 1
measure: Presence/absence of adverse events
timeFrame: Week 2
measure: Presence/absence of adverse events
timeFrame: Week 4
measure: Presence/absence of adverse events
timeFrame: Week 8
measure: Presence/absence of adverse events
timeFrame: Week 12
measure: Presence/absence of adverse events
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Algo plus scale
timeFrame: Baseline (Day 0)
measure: Algo plus scale
timeFrame: Week 1
measure: Algo plus scale
timeFrame: Week 2
measure: Algo plus scale
timeFrame: Week 4
measure: Algo plus scale
timeFrame: Week 8
measure: Algo plus scale
timeFrame: Week 12
measure: Algo plus scale
timeFrame: At treatment stopping if appropriate (before week 12)
measure: Acceptability of the dressing by the medical staff
timeFrame: Week 1
measure: Acceptability of the dressing by the medical staff
timeFrame: Week 2
measure: Acceptability of the dressing by the medical staff
timeFrame: Week 4
measure: Acceptability of the dressing by the medical staff
timeFrame: Week 8
measure: Acceptability of the dressing by the medical staff
timeFrame: Week 12
measure: Acceptability of the dressing by the medical staff
timeFrame: At treatment stopping if appropriate (before week 12)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Mutualiste Neurologique Propara
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes
country: France
facility: CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Philippe Lavigne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: