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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Pressure Ulcer

Treatments: Procedure: Usual care; Device: MELECTIS G

Study type: Interventional

Funder types: Other

Identifiers

NCT02373956

2014-A01407-40 (Other Identifier)

LOCAL/2014/JPL-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

MELECTIS G

Experimental group

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

Treatment:

Device: MELECTIS G

Usual care

Active Comparator group

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

Treatment:

Procedure: Usual care

Device: MELECTIS G