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

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

Study Overview

• Status: Completed
• Conditions: Venous or Mixed Leg Ulcers

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • RCTs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patient population is patient with venous or mixed leg ulcers

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lohmann & Rauscher
• Investigators: Study Director: Daria TROFIMENKO, Lohmann and Rauscher

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2018
• Primary Completion (ACTUAL): January 23, 2020
• Study Completion (ACTUAL): January 23, 2020

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Leg Ulcer
• Other Study ID Numbers: 2017-A02514-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No