An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
Primary Purpose
Acute and Chronic Wounds
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
External Suction Interface and a Silicon Film
Sponsored by
About this trial
This is an interventional treatment trial for Acute and Chronic Wounds
Eligibility Criteria
Inclusion Criteria:
- Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
- 1cm2 ≤ wound size ≤ 200cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written Patient Information
Exclusion Criteria:
- Need for frequent dressing changes, i.e.<48 hours between the changes
- Critical ischemia (for wound healing) according to investigator's judgement
- Malignancy in the wound and/or wound margin
- Target ulcer previous not successfully treated with NPWT within 48 hours
- Poorly controlled diabetes according to investigators judgement.
- Osteomyelitis which has been left untreated
- Infection which has been left untreated
- High risk for bleeding complications
- Exposed blood vessels, organs or nerves
- Current or within 3 months treatment with chemotherapy or irradiation
- Known hypersensitivity to the dressing material
- Expected technically impossible to seal the film to achieve a vacuum treatment
- Expected non compliance with the Clinical Investigation Plan (CIP)
- Pregnancy
- Subjects not suitable for the investigation according to the investigator's judgement
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Sites / Locations
- County Hospital
- Hudmottagningen, Sundsvalls sjukhus
- University Hospital of Örebro
Outcomes
Primary Outcome Measures
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
Secondary Outcome Measures
To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part
Full Information
NCT ID
NCT01286857
First Posted
October 8, 2010
Last Updated
July 15, 2011
Sponsor
Molnlycke Health Care AB
1. Study Identification
Unique Protocol Identification Number
NCT01286857
Brief Title
An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
Official Title
A Prospective, Open, Non-controlled Proof-of-concept Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute and Chronic Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
External Suction Interface and a Silicon Film
Intervention Description
Evaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds.
Primary Outcome Measure Information:
Title
To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site
Time Frame
144 - 288 hours
Secondary Outcome Measure Information:
Title
To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part
Time Frame
144-288 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
1cm2 ≤ wound size ≤ 200cm2
Male or female, 18 years and above
Signed Informed Consent Form
Subject understands the written Patient Information
Exclusion Criteria:
Need for frequent dressing changes, i.e.<48 hours between the changes
Critical ischemia (for wound healing) according to investigator's judgement
Malignancy in the wound and/or wound margin
Target ulcer previous not successfully treated with NPWT within 48 hours
Poorly controlled diabetes according to investigators judgement.
Osteomyelitis which has been left untreated
Infection which has been left untreated
High risk for bleeding complications
Exposed blood vessels, organs or nerves
Current or within 3 months treatment with chemotherapy or irradiation
Known hypersensitivity to the dressing material
Expected technically impossible to seal the film to achieve a vacuum treatment
Expected non compliance with the Clinical Investigation Plan (CIP)
Pregnancy
Subjects not suitable for the investigation according to the investigator's judgement
Subjects previously included in this investigation
Subjects included in other ongoing clinical investigation at present or during the past 30 days
Facility Information:
Facility Name
County Hospital
City
Halmstad
ZIP/Postal Code
SE-301 85
Country
Sweden
Facility Name
Hudmottagningen, Sundsvalls sjukhus
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
University Hospital of Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds
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