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

Acute Non Infected Wounds Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195896
• Other study ID #: NPWT 02
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: January 13, 2012
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Non Infected Wounds
• Non Infected Post Surgical Wounds
• Wound Infection

Intervention

Device:
• New NPWT system
According clinical routine (Instruction for Use)

Locations

Country	Name	City	State
Germany	Ulm University Hospital	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Granulation tissue formation	To assess the wound healing and granulation tissue formation when using the NPWT system	maximum 3 weeks	No
Secondary	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	No