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Completed

NCT Number: NCT01286857

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

County Hospital, Halmstad, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
  • 1cm2 ≤ wound size ≤ 200cm2
  • Male or female, 18 years and above
  • Signed Informed Consent Form
  • Subject understands the written Patient Information

Exclusion criteria

  • 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
  • Subjects previously included in this investigation
  • Subjects included in other ongoing clinical investigation at present or during the past 30 days

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

    Time frame: 144-288 hours

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 31, 2011
Registry last updated
Jul 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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