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

NCT ID: NCT01195896

Last Updated: 2012-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

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.

Conditions

Acute Non Infected Wounds; Non Infected Post Surgical Wounds

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

New NPWT system

According clinical routine (Instruction for Use)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Bischoff, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

Ulm University Hospital

Locations

Ulm University Hospital

Ulm, , Germany

Countries

Germany

Other Identifiers

NPWT 02

Identifier Type: -

Identifier Source: org_study_id