Trials / Completed

CompletedNCT01195896

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

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 9 (actual)

Sponsor: Molnlycke Health Care AB · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	New NPWT system	According clinical routine (Instruction for Use)

Timeline

Start date: 2010-09-01
Primary completion: 2011-08-01
Completion: 2011-09-01
First posted: 2010-09-06
Last updated: 2012-01-16

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01195896. Inclusion in this directory is not an endorsement.