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

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.

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

Study Overview

• Status: Completed
• Conditions: Acute Non Infected Wounds; Non Infected Post Surgical Wounds
• Intervention / Treatment: Device: New NPWT system

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany
    • Ulm University Hospital

Participation Criteria

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. 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

Study Plan

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	Measure Description	Time Frame
Granulation tissue formation	To assess the wound healing and granulation tissue formation when using the NPWT system	maximum 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	maximum 3 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Mark Bischoff, Prof. Dr. med, Ulm University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): January 16, 2012
• Last Update Submitted That Met QC Criteria: January 13, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Surgical Wound; Wound Infection
• Other Study ID Numbers: NPWT 02