Efficacy and Tolerance of Honey-impregnated Dressings in the Local Management of Pressure Ulcers
- Conditions
- Pressure Ulcer
- Interventions
- Device: MELECTIS GProcedure: Usual care
- Registration Number
- NCT02373956
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MELECTIS G 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 Usual care 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 Usual care 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
- Primary Outcome Measures
Name Time Method Change in wound surface area according to the Gilman formula Week 12 According to the Gilman formula
- Secondary Outcome Measures
Name Time Method Is the wound completely healed? yes/no Week 12 Presence/absence of adverse events At treatment stopping if appropriate (before week 12) 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) Number of bacteria functional groups present in the wound Day 84 Functional groups: commensal, pathogenic, weak pathogenic potential
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 Day 84 The number of multiresistant bacteria species present in the wound Day 84 The time to healing (days) Week 12 Change in wound surface area according to the Gilman formula At treatment stopping if appropriate (before week 12) According to the Gilman formula
the ratio of the number of commensal over the total number of bacteria species present in the wound Day 84 Relative variation (%) in wound surface area At treatment stopping if appropriate (before week 12) Relative variation (%) in wound depth At treatment stopping if appropriate (before week 12) Diversity (Shannon's H) of bacteria species present in the wound Day 84 Diversity (Shannon's H) of bacteria functional groups present in the wound Day 84 Functional groups: commensal, pathogenic, weak pathogenic potential
the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound Day 84 Appearance of the pressure ulcer At treatment stopping if appropriate (before week 12) Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor
Algo plus scale At treatment stopping if appropriate (before week 12) Acceptability of the dressing by the medical staff At treatment stopping if appropriate (before week 12) 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
Trial Locations
- Locations (3)
Centre Mutualiste Neurologique Propara
🇫🇷Montpellier, France
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier
🇫🇷Nîmes, France