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

This study has been completed.
Sponsor:
Information provided by:
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01286857
First received: October 8, 2010
Last updated: July 15, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Acute and Chronic Wounds
Device: External Suction Interface and a Silicon Film
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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 [ Time Frame: 144-288 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: External Suction Interface and a Silicon Film
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286857

Locations
Sweden
County Hospital
Halmstad, Sweden, SE-301 85
Hudmottagningen, Sundsvalls sjukhus
Sundsvall, Sweden, 851 86
University Hospital of Örebro
Örebro, Sweden, 701 85
Sponsors and Collaborators
Molnlycke Health Care AB
  More Information

No publications provided

Responsible Party: Ruth Eid-Forest, MD, Dept. of Dermatology, University Hospital of Orebro, Sweden
ClinicalTrials.gov Identifier: NCT01286857     History of Changes
Other Study ID Numbers: SIMP 01
Study First Received: October 8, 2010
Last Updated: July 15, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014