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

Pressure Ulcer Clinical Trial

— MeliCare  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02373956
• Other study ID #: LOCAL/2014/JPL-01
• Secondary ID: 2014-A01407-40
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2015
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• MELECTIS G
The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.

Procedure:
• Usual care
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).

Locations

Country	Name	City	State
France	Centre Mutualiste Neurologique Propara	Montpellier
France	CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier	Nîmes
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	MELIPHARM SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 12
Secondary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 1
Secondary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 2
Secondary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 4
Secondary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 8
Secondary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	Week 12
Secondary	Change in wound surface area according to the Gilman formula	According to the Gilman formula	At treatment stopping if appropriate (before week 12)
Secondary	Relative variation (%) in wound surface area		Week 1
Secondary	Relative variation (%) in wound surface area		Week 2
Secondary	Relative variation (%) in wound surface area		Week 4
Secondary	Relative variation (%) in wound surface area		Week 8
Secondary	Relative variation (%) in wound surface area		Week 12
Secondary	Relative variation (%) in wound surface area		At treatment stopping if appropriate (before week 12)
Secondary	Relative variation (%) in wound depth		Week 1
Secondary	Relative variation (%) in wound depth		Week 2
Secondary	Relative variation (%) in wound depth		Week 4
Secondary	Relative variation (%) in wound depth		Week 8
Secondary	Relative variation (%) in wound depth		Week 12
Secondary	Relative variation (%) in wound depth		At treatment stopping if appropriate (before week 12)
Secondary	Has the wound surface area reduced by at least 40%? yes/no		Week 2
Secondary	Has the wound surface area reduced by at least 40%? yes/no		Week 4
Secondary	Has the wound surface area reduced by at least 40%? yes/no		Week 8
Secondary	Has the wound surface area reduced by at least 40%? yes/no		Week 12
Secondary	Has the wound surface area reduced by at least 40%? yes/no		At treatment stopping if appropriate (before week 12)
Secondary	Number of bacteria species present in the wound		Baseline (Day 0)
Secondary	Number of bacteria species present in the wound		Day 14
Secondary	Number of bacteria species present in the wound		Day 84
Secondary	Diversity (Shannon's H) of bacteria species present in the wound		Baseline (Day 0)
Secondary	Diversity (Shannon's H) of bacteria species present in the wound		Day 14
Secondary	Diversity (Shannon's H) of bacteria species present in the wound		Day 84
Secondary	Number of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Baseline (Day 0)
Secondary	Number of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 14
Secondary	Number of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 84
Secondary	Diversity (Shannon's H) of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Baseline (Day 0)
Secondary	Diversity (Shannon's H) of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 14
Secondary	Diversity (Shannon's H) of bacteria functional groups present in the wound	Functional groups: commensal, pathogenic, weak pathogenic potential	Day 84
Secondary	The number of multiresistant bacteria species present in the wound		Baseline (Day 0)
Secondary	The number of multiresistant bacteria species present in the wound		Day 14
Secondary	The number of multiresistant bacteria species present in the wound		Day 84
Secondary	the ratio of the number of commensal over the total number of bacteria species present in the wound		Baseline (Day 0)
Secondary	the ratio of the number of commensal over the total number of bacteria species present in the wound		Day 14
Secondary	the ratio of the number of commensal over the total number of bacteria species present in the wound		Day 84
Secondary	the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound		Baseline (Day 0)
Secondary	the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound		Day 14
Secondary	the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound		Day 84
Secondary	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)
Secondary	Is the wound completely healed? yes/no		Week 12
Secondary	The time to healing (days)		Week 12
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Baseline (Day 0)
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 1
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 2
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 4
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 8
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	Week 12
Secondary	Appearance of the pressure ulcer	Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor	At treatment stopping if appropriate (before week 12)
Secondary	Presence/absence of adverse events		Week 1
Secondary	Presence/absence of adverse events		Week 2
Secondary	Presence/absence of adverse events		Week 4
Secondary	Presence/absence of adverse events		Week 8
Secondary	Presence/absence of adverse events		Week 12
Secondary	Presence/absence of adverse events		At treatment stopping if appropriate (before week 12)
Secondary	Algo plus scale		Baseline (Day 0)
Secondary	Algo plus scale		Week 1
Secondary	Algo plus scale		Week 2
Secondary	Algo plus scale		Week 4
Secondary	Algo plus scale		Week 8
Secondary	Algo plus scale		Week 12
Secondary	Algo plus scale		At treatment stopping if appropriate (before week 12)
Secondary	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	Week 1
Secondary	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	Week 2
Secondary	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	Week 4
Secondary	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	Week 8
Secondary	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	Week 12
Secondary	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	At treatment stopping if appropriate (before week 12)