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Trial record 9 of 51 for:    Recruiting, Not yet recruiting, Available Studies | "Pressure Ulcer"

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

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ClinicalTrials.gov Identifier: NCT02373956
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
MELIPHARM SAS
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: MELECTIS G Procedure: Usual care Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 20, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: 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

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

Active Comparator: 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

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).




Primary Outcome Measures :
  1. Change in wound surface area according to the Gilman formula [ Time Frame: Week 12 ]
    According to the Gilman formula


Secondary Outcome Measures :
  1. Change in wound surface area according to the Gilman formula [ Time Frame: Week 1 ]
    According to the Gilman formula

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

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

  4. Change in wound surface area according to the Gilman formula [ Time Frame: Week 8 ]
    According to the Gilman formula

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

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

  7. Relative variation (%) in wound surface area [ Time Frame: Week 1 ]
  8. Relative variation (%) in wound surface area [ Time Frame: Week 2 ]
  9. Relative variation (%) in wound surface area [ Time Frame: Week 4 ]
  10. Relative variation (%) in wound surface area [ Time Frame: Week 8 ]
  11. Relative variation (%) in wound surface area [ Time Frame: Week 12 ]
  12. Relative variation (%) in wound surface area [ Time Frame: At treatment stopping if appropriate (before week 12) ]
  13. Relative variation (%) in wound depth [ Time Frame: Week 1 ]
  14. Relative variation (%) in wound depth [ Time Frame: Week 2 ]
  15. Relative variation (%) in wound depth [ Time Frame: Week 4 ]
  16. Relative variation (%) in wound depth [ Time Frame: Week 8 ]
  17. Relative variation (%) in wound depth [ Time Frame: Week 12 ]
  18. Relative variation (%) in wound depth [ Time Frame: At treatment stopping if appropriate (before week 12) ]
  19. Has the wound surface area reduced by at least 40%? yes/no [ Time Frame: Week 2 ]
  20. Has the wound surface area reduced by at least 40%? yes/no [ Time Frame: Week 4 ]
  21. Has the wound surface area reduced by at least 40%? yes/no [ Time Frame: Week 8 ]
  22. Has the wound surface area reduced by at least 40%? yes/no [ Time Frame: Week 12 ]
  23. Has the wound surface area reduced by at least 40%? yes/no [ Time Frame: At treatment stopping if appropriate (before week 12) ]
  24. Number of bacteria species present in the wound [ Time Frame: Baseline (Day 0) ]
  25. Number of bacteria species present in the wound [ Time Frame: Day 14 ]
  26. Number of bacteria species present in the wound [ Time Frame: Day 84 ]
  27. Diversity (Shannon's H) of bacteria species present in the wound [ Time Frame: Baseline (Day 0) ]
  28. Diversity (Shannon's H) of bacteria species present in the wound [ Time Frame: Day 14 ]
  29. Diversity (Shannon's H) of bacteria species present in the wound [ Time Frame: Day 84 ]
  30. Number of bacteria functional groups present in the wound [ Time Frame: Baseline (Day 0) ]
    Functional groups: commensal, pathogenic, weak pathogenic potential

  31. Number of bacteria functional groups present in the wound [ Time Frame: Day 14 ]
    Functional groups: commensal, pathogenic, weak pathogenic potential

  32. Number of bacteria functional groups present in the wound [ Time Frame: Day 84 ]
    Functional groups: commensal, pathogenic, weak pathogenic potential

  33. Diversity (Shannon's H) of bacteria functional groups present in the wound [ Time Frame: Baseline (Day 0) ]
    Functional groups: commensal, pathogenic, weak pathogenic potential

  34. Diversity (Shannon's H) of bacteria functional groups present in the wound [ Time Frame: Day 14 ]
    Functional groups: commensal, pathogenic, weak pathogenic potential

  35. Diversity (Shannon's H) of bacteria functional groups present in the wound [ Time Frame: Day 84 ]
    Functional groups: commensal, pathogenic, weak pathogenic potential

  36. The number of multiresistant bacteria species present in the wound [ Time Frame: Baseline (Day 0) ]
  37. The number of multiresistant bacteria species present in the wound [ Time Frame: Day 14 ]
  38. The number of multiresistant bacteria species present in the wound [ Time Frame: Day 84 ]
  39. the ratio of the number of commensal over the total number of bacteria species present in the wound [ Time Frame: Baseline (Day 0) ]
  40. the ratio of the number of commensal over the total number of bacteria species present in the wound [ Time Frame: Day 14 ]
  41. the ratio of the number of commensal over the total number of bacteria species present in the wound [ Time Frame: Day 84 ]
  42. 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) ]
  43. 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 ]
  44. 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 ]
  45. 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) ]
  46. Is the wound completely healed? yes/no [ Time Frame: Week 12 ]
  47. The time to healing (days) [ Time Frame: Week 12 ]
  48. Appearance of the pressure ulcer [ Time Frame: Baseline (Day 0) ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  49. Appearance of the pressure ulcer [ Time Frame: Week 1 ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  50. Appearance of the pressure ulcer [ Time Frame: Week 2 ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  51. Appearance of the pressure ulcer [ Time Frame: Week 4 ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  52. Appearance of the pressure ulcer [ Time Frame: Week 8 ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  53. Appearance of the pressure ulcer [ Time Frame: Week 12 ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  54. Appearance of the pressure ulcer [ Time Frame: At treatment stopping if appropriate (before week 12) ]
    Appearance of the pressure ulcer: burgeoning, fibrinous, necrotic, blistering or de-epidermisation, exudative, bad odor

  55. Presence/absence of adverse events [ Time Frame: Week 1 ]
  56. Presence/absence of adverse events [ Time Frame: Week 2 ]
  57. Presence/absence of adverse events [ Time Frame: Week 4 ]
  58. Presence/absence of adverse events [ Time Frame: Week 8 ]
  59. Presence/absence of adverse events [ Time Frame: Week 12 ]
  60. Presence/absence of adverse events [ Time Frame: At treatment stopping if appropriate (before week 12) ]
  61. Algo plus scale [ Time Frame: Baseline (Day 0) ]
  62. Algo plus scale [ Time Frame: Week 1 ]
  63. Algo plus scale [ Time Frame: Week 2 ]
  64. Algo plus scale [ Time Frame: Week 4 ]
  65. Algo plus scale [ Time Frame: Week 8 ]
  66. Algo plus scale [ Time Frame: Week 12 ]
  67. Algo plus scale [ Time Frame: At treatment stopping if appropriate (before week 12) ]
  68. Acceptability of the dressing by the medical staff [ Time Frame: Week 1 ]

    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

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

    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

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

    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

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

    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

  72. Acceptability of the dressing by the medical staff [ Time Frame: 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

  73. 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 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373956


Contacts
Contact: Jean-Philippe Lavigne, MD, PhD +33.(0)4.66.68.32.02 jean.philippe.lavigne@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Centre Mutualiste Neurologique Propara Recruiting
Montpellier, France, 34090
Contact: Anthony GELIS         
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Jean-Philippe Lavigne, MD, PhD         
Sub-Investigator: Catherine Dunyach-Rémy, PhD         
Sub-Investigator: Albert Sotto, MD, PhD         
Sub-Investigator: Benoît de Wasières, MD, PhD         
Sub-Investigator: Arnaud Dupeyron, MD,PhD         
CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier Recruiting
Nîmes, France, 30029
Sub-Investigator: Sabine Rouvière, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
MELIPHARM SAS
Investigators
Principal Investigator: Jean-Philippe Lavigne, MD, PhD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02373956     History of Changes
Other Study ID Numbers: LOCAL/2014/JPL-01
2014-A01407-40 ( Other Identifier: RCB number )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases