NCT02431741
Completed
Not Applicable
Title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Molnlycke Health Care AB2 sites in 1 country14 target enrollmentOctober 2014
ConditionsMalignant Wounds
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Wounds
- Sponsor
- Molnlycke Health Care AB
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Infection in the Wound (Signs of Clinical Infection)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Infection in the Wound (Signs of Clinical Infection)
Time Frame: weekly, for 5 weeks
Weekly Visual inspection of the wounds by the investigators.
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a New Negative Pressure Wound Therapy (NPWT) System to be Used in the Treatment of Acute Non-infected Wounds and Post Surgical Infected WoundsAcute Non Infected WoundsNon Infected Post Surgical WoundsNCT01195896Molnlycke Health Care AB9
Completed
Not Applicable
Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of OnychomycosisOnychomycosis of ToenailsNCT02546258Reckitt Benckiser Healthcare (UK) Limited60
Completed
Not Applicable
PillSense System for Detecting UGI BleedUGI BleedUpper Gastrointestinal BleedingUpper Gastrointestinal BleedNCT05385224EnteraSense Limited131
Not yet recruiting
Phase 3
An open clinical study to evaluate the clinical efficacy of Siddha sasthric formulation UTHAMANI KARUKKU for the treatment of KANA MAANTHAM.Health Condition 1: K522- Allergic and dietetic gastroenteritis and colitisHealth Condition 2: null- Kana MaanthamCTRI/2018/06/014544DrDEaswari
Recruiting
Phase 4
A clinical study to evaluate the performance and safety of phaco machine.Health Condition 1: H259- Unspecified age-related cataractCTRI/2023/03/050394Grewal Eye Institute