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 Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01195896
First received: September 3, 2010
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

The investigation is designed as a prospective, open, non-controlled clinical investigation.


Condition Intervention
Acute Non Infected Wounds
Non Infected Post Surgical Wounds
Device: New NPWT system

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 Wounds.

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Granulation tissue formation [ Time Frame: maximum 3 weeks ] [ Designated as safety issue: No ]
    To assess the wound healing and granulation tissue formation when using the NPWT system


Secondary Outcome Measures:
  • Handling of NPWT system [ Time Frame: maximum 3 weeks ] [ Designated as safety issue: No ]
    To investigate the pain level at dressing removal To visually check exudate removal To investigate the ease of use for the subject and care giver when using the NPWT system


Enrollment: 9
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: New NPWT system
    According clinical routine (Instruction for Use)
Detailed Description:

Wounds to be treated under this protocol should be acute non-infected wounds or post surgical infected wounds in hospitalized subjects. One ulcer per subject will be treated for a maximum duration of 3 weeks. All subjects will receive continuous negative pressure treatment with the new NPWT system with a pressure level of -120 mmHg or according to clinicians' instruction based on the indication.

10-15 subjects at two sites will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and who have signed and dated a written informed consent.

The subjects will be consecutively allocated to a specific subject identification code. The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.

Subject pain will be measured by using the Visual Analogue Scale, VAS. Subject and investigator convenience will be assessed by convenience surveys. Diagnosis and treatment of wound infections according to clinical routine.

  Eligibility

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

Inclusion Criteria:

  1. Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment
  2. 3 cm2 ≤ Wound size ≤ 300 cm2
  3. Male or female ≥18 years
  4. Signed Informed Consent Form

Exclusion Criteria:

  1. Need for frequent dressing changes, i.e.<48 hours between the changes
  2. Dry wounds
  3. Malignancy in the wound and/or wound margin
  4. Untreated osteomyelitis
  5. Untreated infection waiting for other intervention
  6. Unexplored fistulas
  7. > 10% necrotic tissue with eschar present after debridement
  8. High risk for bleeding complications (including subject treated with anticoagulants that are associated with 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
  14. Pregnancy
  15. Subjects previously included in this investigation
  16. Subjects included in other ongoing clinical investigation at present or during the past 30 days
  17. Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start
  18. Subject unable to understand written patient information due to medical condition
  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: NCT01195896

Locations
Germany
Ulm University Hospital
Ulm, Germany
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Mark Bischoff, Prof. Dr. med Ulm University Hospital
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01195896     History of Changes
Other Study ID Numbers: NPWT 02
Study First Received: September 3, 2010
Last Updated: January 13, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014