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

July 15, 2011 updated by: Molnlycke Health Care AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Halmstad, Sweden, SE-301 85
        • County Hospital
      • Sundsvall, Sweden, 851 86
        • Hudmottagningen, Sundsvalls sjukhus
      • Örebro, Sweden, 701 85
        • University Hospital of Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
  2. 1cm2 ≤ wound size ≤ 200cm2
  3. Male or female, 18 years and above
  4. Signed Informed Consent Form
  5. Subject understands the written Patient Information

Exclusion Criteria:

  1. Need for frequent dressing changes, i.e.<48 hours between the changes
  2. Critical ischemia (for wound healing) according to investigator's judgement
  3. Malignancy in the wound and/or wound margin
  4. Target ulcer previous not successfully treated with NPWT within 48 hours
  5. Poorly controlled diabetes according to investigators judgement.
  6. Osteomyelitis which has been left untreated
  7. Infection which has been left untreated
  8. High risk for bleeding complications
  9. Exposed blood vessels, organs or nerves
  10. Current or within 3 months treatment with chemotherapy or irradiation
  11. Known hypersensitivity to the dressing material
  12. Expected technically impossible to seal the film to achieve a vacuum treatment
  13. Expected non compliance with the Clinical Investigation Plan (CIP)
  14. Pregnancy
  15. Subjects not suitable for the investigation according to the investigator's judgement
  16. Subjects previously included in this investigation
  17. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
144 - 288 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
144-288 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molnlycke Health Care AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

July 18, 2011

Last Update Submitted That Met QC Criteria

July 15, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMP 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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