to study search History No further version available for comparison

Multicenter, randomised in parallel groups, non-inferiority study to compare efficacy and safety of the “new” Suprasorb® CNP wound foam dressing with the “old” Suprasorb® CNP wound foam dressing during negative pressure wound therapy (“FOAM”).

Organizational Data

DRKS-ID:
DRKS00025394
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2021-09-02
Last update in DRKS:
2021-09-02
Registration type:
Prospective

Acronym/abbreviation of the study

FOAM

URL of the study

http://NA

Brief summary in lay language

The aim of this study is to examine whether the sponge used during treatment - a component of the wound treatment system - is just as safe and reliable in its new design as the previous model. It is investigated whether a difference in the speed of wound healing can be observed when using the new version of the sponge. Changes in the connective tissue during wound healing and possible infections are also documented. Both versions of the sponge are already CE-marked and can therefore be used in routine clinical practice without restrictions.

Brief summary in scientific language

This clinical investigation will be conducted as a multicenter, randomised in parallel groups, non-inferiority study on patients with acute or chronic soft tissue traumatic wounds (including soft tissue defects with exposed tendons and/ or non-fractured bones), which are unlikely to heal by a primary intention due to size or other accompanying factors, and for which NPWT seems beneficial as a preparatory stage before skin grafting. After enrolment, all patients will be randomly assigned to two treatment arms: with a “new” foam and an "old" foam. The patients in both groups will receive NPWT till the surgical closure (including skin graft and flap surgery) of the wound become possible, but not longer, as for 4 weeks. After 4 weeks of treatment, all patients will complete the study. Their further treatment (if necessary) will not be a part of the study.

Health condition or problem studied

ICD10:
T14 - Injury of unspecified body region
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
NPWT with an "old" wound foam till the surgical closure (including skin graft and flap surgery) of the wound become possible, but not longer, as for 4 weeks.
Arm 2:
NPWT with a "new" wound foam till the surgical closure (including skin graft and flap surgery) of the wound become possible, but not longer, as for 4 weeks.

Endpoints

Primary outcome:
Rate of the wounds, ready for a skin grafting after 4 weeks of the NPWT
Secondary outcome:
- Time to achieved wound bed readiness for a skin grafting - Wound area changes over time - Change of fibrinous / granulation tissue rate in the wound bed - Infection rate (total, rates of superficial and deep infections) and change of wound infection status during the study. - Product safety (defined by rate of product-related complications) - Change of wound exudation and presence of peri-wound edema - Change in patients’ pain (measured by VAS scale) and patients’ need for anesthetics (assessed by rate of pain medication prescription) - Product usability (assessed by means of user questionnaire)

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Plastic and Hand Surgery, TUM München
  • Medical center BG-Kliniken Umfallkrankenhaus Berlin Berlin
  • Medical center Helios Klinikum Berlin-Buch Berlin
  • Medical center BG-Kliniken Bergmannstrost Halle Halle Saale

Recruitment period and number of participants

Planned study start date:
2021-09-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
114
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- Age ≥ 18 years - Acute or chronic soft-tissue traumatic wound (including soft tissue defects with exposed tendons and/ or non-fractured bones), which is unlikely to heal by a primary intention due to size or other accompanying factors, and for which NPWT seems beneficial as a preparatory stage before skin grafting. - Patient has signed informed consent

Exclusion Criteria

- Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomization and during the whole duration of this study - Wounds with exposed vessels, vascular anastomoses or viscera - Unexplored fistulas in the area of the study wound - Acute bleeding in the area of the study wound - Necrotic wound - Untreated osteomyelitis in the area of the study wound - Wound in the sternum area (except of sternal wound infections after surgical debridement) - Known intolerance or allergy to the product or any of its ingredients - System coagulation disorders (increased risk of bleeding) - Any other medical condition, which may have impact of the success of the study treatment and / or interpretation of the study results (e.g. diabetes, peripheral arterial disease, chronic venous disease).

Addresses

Primary Sponsor

Lohmann & Rauscher GmbH & Co. KG
Dr Daria Trofimenko
Irlicher Straße 55
56567 Neuwied
Germany
Telephone:
+49 (0)2631- 99 6385
Fax:
+49 (0)2631- 99 1385
Contact per E-Mail
URL:
http://www.Lohmann-Rauscher.com
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

BG-Kliniken Umfallkrankenhaus Berlin
Dr Bernd Hartmann
Warener Str. 7
12683 Berlin
Germany
Telephone:
+493056813501
Fax:
+493056813501
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

BG-Kliniken Umfallkrankenhaus Berlin
Dr Bernd Hartmann
Warener Str. 7
12683 Berlin
Germany
Telephone:
+493056813501
Fax:
+493056813501
Contact per E-Mail
URL:
No Entry

Principal Investigator

BG-Kliniken Umfallkrankenhaus Berlin
Dr Bernd Hartmann
Warener Str. 7
12683 Berlin
Germany
Telephone:
+493056813501
Fax:
+493056813501
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Lohmann & Rauscher GmbH & Co. KG
Irlicher Straße 55
56567 Neuwied
Germany
Telephone:
+49 (0)2631- 99 6385
Fax:
+49 (0)2631- 99 1385
Contact per E-Mail
URL:
http://www.Lohmann-Rauscher.com

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Ärztekammer Berlin
Friedrichstraße 16
10696 Berlin
Germany
Telephone:
(+49)30-408062601
Fax:
(+49)30-408062298
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-06-29
Ethics committee number:
Eth-48/21
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-08-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry