Malignant Wounds
Conditions
Keywords
Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
Brief summary
This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a study site. Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.
Interventions
DEVICEMepilex Transfer Ag
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment * Both genders with an age ≥ 18 years at randomization * Subjects with a suspected survival time of \> 3 months * Signed informed consent
Exclusion criteria
* Any known or suspected systemic infection * Use of metronidazole is not allowed during the investigation period * Any known sensitivity to silver or other components/products used in this study. * Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders. * Participation in another investigational study while participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection in the Wound (Signs of Clinical Infection) | weekly, for 5 weeks | Weekly Visual inspection of the wounds by the investigators. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepilex Transfer Ag Non controlled investigation
Mepilex Transfer Ag | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Mepilex Transfer Ag |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Exudate handling | 14 participants |
| Infections in the wound at baseline | 14 participants |
| Pain during dressing changes | 14 participants |
| Presence of bleeding from tumor | 14 participants |
| Presence of malodour | 14 participants |
| Region of Enrollment Czech Republic | 14 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Infection in the Wound (Signs of Clinical Infection)
Weekly Visual inspection of the wounds by the investigators.
Time frame: weekly, for 5 weeks
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mepilex Transfer Ag | Infection in the Wound (Signs of Clinical Infection) | 14 participants |