NCT02373956

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

November 20, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

5 years

First QC Date

February 23, 2015

Last Update Submit

August 3, 2021

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Change in wound surface area according to the Gilman formula

    According to the Gilman formula

    Week 12

Secondary Outcomes (73)

  • Change in wound surface area according to the Gilman formula

    Week 1

  • Change in wound surface area according to the Gilman formula

    Week 2

  • Change in wound surface area according to the Gilman formula

    Week 4

  • Change in wound surface area according to the Gilman formula

    Week 8

  • Change in wound surface area according to the Gilman formula

    Week 12

  • +68 more secondary outcomes

Study Arms (2)

MELECTIS G

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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 GProcedure: Usual care

Interventions

MELECTIS GDEVICE

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

MELECTIS GUsual care
Usual carePROCEDURE

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).

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • Stage 1 wound according to the EPUAP-NPUAP classification
  • Amputation wound
  • Malignant wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Mutualiste Neurologique Propara

Montpellier, 34090, France

Location

CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier

Nîmes, 30029, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-Philippe Lavigne, MD, PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

November 20, 2015

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations

FR(3)