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

NCT01286857 | Completed Phase 2

• 1 other identifier: SIMP 01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute and Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• To evaluate the transport of exudate from the wound bed to canister and thus distribute negative pressure in the wound site

  144 - 288 hours

Secondary Outcomes (1)

• 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

Interventions

External Suction Interface and a Silicon Film DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
• cm2 ≤ wound size ≤ 200cm2
• Male or female, 18 years and above
• Signed Informed Consent Form
• Subject understands the written Patient Information

You may not qualify if:

• Need for frequent dressing changes, i.e.\<48 hours between the changes
• Critical ischemia (for wound healing) according to investigator's judgement
• Malignancy in the wound and/or wound margin
• Target ulcer previous not successfully treated with NPWT within 48 hours
• Poorly controlled diabetes according to investigators judgement.
• Osteomyelitis which has been left untreated
• Infection which has been left untreated
• 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 (CIP)
• Pregnancy
• Subjects not suitable for the investigation according to the investigator's judgement

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (3)

County Hospital

Halmstad, Halmstad, SE-301 85, Sweden

Location

University Hospital of Örebro

Örebro, 701 85, Sweden

Location

Hudmottagningen, Sundsvalls sjukhus

Sundsvall, 851 86, Sweden

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: January 31, 2011
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

SE (3)