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CompletedNCT01286857Updated Jul 18, 2011

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

A Phase 2/3 interventional study of External Suction Interface and a Silicon Film in Acute and Chronic Wounds, sponsored by Molnlycke Health Care AB. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-18.

Sponsored by Molnlycke Health Care AB · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute and Chronic Wounds

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's planned enrollment of 15 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Interventions

  • DeviceExternal 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.

06

What researchers measure

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

07

Study locations

3 sites
  • County Hospital
    Halmstad, SE-301 85, Sweden
  • Hudmottagningen, Sundsvalls sjukhus
    Sundsvall, 851 86, Sweden
  • University Hospital of Örebro
    Örebro, 701 85, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01286857
Lead sponsor
Molnlycke Health Care AB
First posted
Jan 31, 2011
Start date
Sep 2010
Primary completion
May 2011
Completion
May 2011
Last update
Jul 18, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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