An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds

Acute and Chronic Wounds Clinical Trial

Official title:

A Prospective, Open, Non-controlled Proof-of-concept Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286857
• Other study ID #: SIMP 01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 8, 2010
• Last updated: July 15, 2011
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment

2. 1cm2 = wound size = 200cm2

3. Male or female, 18 years and above

4. Signed Informed Consent Form

5. Subject understands the written Patient Information

Exclusion Criteria:

1. Need for frequent dressing changes, i.e.<48 hours between the changes

2. Critical ischemia (for wound healing) according to investigator's judgement

3. Malignancy in the wound and/or wound margin

4. Target ulcer previous not successfully treated with NPWT within 48 hours

5. Poorly controlled diabetes according to investigators judgement.

6. Osteomyelitis which has been left untreated

7. Infection which has been left untreated

8. 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 (CIP)

14. Pregnancy

15. Subjects not suitable for the investigation according to the investigator's judgement

16. Subjects previously included in this investigation

17. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Study Design

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

Related Conditions & MeSH terms

• Acute and Chronic Wounds

Intervention

Device:
• External Suction Interface and a Silicon Film
Evaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds.

Locations

Country	Name	City	State
Sweden	County Hospital	Halmstad
Sweden	University Hospital of Örebro	Örebro
Sweden	Hudmottagningen, Sundsvalls sjukhus	Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site		144 - 288 hours	No
Secondary	To investigate the practical properties and management of the device, to evaluate the ease of use for the subject and the care giver and to assess any undesirable effects with the suction part		144-288 hours	No