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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

Primary Purpose

Acute Non Infected Wounds, Non Infected Post Surgical Wounds

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
New NPWT system
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Non Infected Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulm University Hospital

Outcomes

Primary Outcome Measures

Granulation tissue formation
To assess the wound healing and granulation tissue formation when using the NPWT system

Secondary Outcome Measures

Handling of NPWT system
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

Full Information

First Posted
September 3, 2010
Last Updated
January 13, 2012
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT01195896
Brief 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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Non Infected Wounds, Non Infected Post Surgical Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
New NPWT system
Intervention Description
According clinical routine (Instruction for Use)
Primary Outcome Measure Information:
Title
Granulation tissue formation
Description
To assess the wound healing and granulation tissue formation when using the NPWT system
Time Frame
maximum 3 weeks
Secondary Outcome Measure Information:
Title
Handling of NPWT system
Description
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
Time Frame
maximum 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute non infected wound or infected post surgical wound suitable for Negative Pressure Wound Therapy according to the investigator's judgment 3 cm2 ≤ Wound size ≤ 300 cm2 Male or female ≥18 years Signed Informed Consent Form Exclusion Criteria: Need for frequent dressing changes, i.e.<48 hours between the changes Dry wounds Malignancy in the wound and/or wound margin Untreated osteomyelitis Untreated infection waiting for other intervention Unexplored fistulas > 10% necrotic tissue with eschar present after debridement High risk for bleeding complications (including subject treated with anticoagulants that are associated with 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 Pregnancy Subjects previously included in this investigation Subjects included in other ongoing clinical investigation at present or during the past 30 days Target ulcer previously not successfully treated with NPWT within 48 hours from NPWT start Subject unable to understand written patient information due to medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bischoff, Prof. Dr. med
Organizational Affiliation
Ulm University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulm University Hospital
City
Ulm
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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