Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing

Venous or Mixed Leg Ulcers Clinical Trial

— Suprasorb®C  

Official title:

Post-Market Clinical-Follow-Up Study of Suprasorb® C Collagen Wound Dressing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444597
• Other study ID #: 2017-A02514-49
• Status: Completed
• Start date: January 24, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: February 2020
• Source: Lohmann & Rauscher
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-Market Clinical-Follow-Up Study of Suprasorb® C collagen wound dressing

Description:

Prospective, uncontrolled multi-center, observational cohort study. The objectives of the PMCF study are confirmation of the performance, and to collect additional safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb®C under the conditions of routine use.

Suprasorb® C collagen wound dressing is a certified medical device (manufacturer: Lohmann & Rauscher International GmbH & Co. KG). The product has been marketed in the EU since 1983 as Opragen® (medicinal product), since 1995 as the medical device Opraskin® and since 2001 under the name Suprasorb C (medical device).

Suprasorb® C is intended to be used as a wound dressing for the support of wound healing or wound area reduction.

Participating Centers: 40 study nurses will participate to the PMCF Study Duration: 24 months Cohort size: 110 patients Follow-up: 8 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient over 18 years of age and under 85 years of age

• Patient suffering from confirmed venous or mixed vascular leg ulcers

• Stagnating wound conditions, i.e. exudation phase > 2 months, not responding to traditional dressing and standard treatment (standard treatment is a clear definition and for venous ulcers compression should be included)

• Target ulcers between 2 cm and 10 cm in the largest diameter

• Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits

Exclusion Criteria:

Use of Suprasorb® C collagen wound dressing is contraindicated according to the current IFU:

• Clinically infected areas

• Presence of known allergies to one or several of its components.

In addition following patients shall not be included into this study:

• Patient not covered by health insurance/social security

• Patient suffering serious life threatening disease

• Pregnant or breastfeeding women

• Minor patient, protected adult, person without liberty

Related Conditions & MeSH terms

• Leg Ulcer
• Venous or Mixed Leg Ulcers

Locations

Country	Name	City	State
France	RCTs	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Lohmann & Rauscher

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of healing after application of Suprasorb® C collagen wound dressing is used as parameter for performance evaluation	Progression of healing after application of Suprasorb® C collagen	Progression of healing is assessed at 8 weeks
Secondary	Frequency and severity of adverse events	Frequency and severity of adverse events, incidences, as well as known risk and side effects, i.e. wound infection, side effects in the group of allergic disorders, pain, and maceration	Frequency and severity is assessed up to 8 weeks