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”).

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”). - FOAM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025394

Enrollment

114

Registered

2021-09-02

Start date

2022-06-30

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T14

Interventions

Group 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. Group 2: NPWT with a "new" wound

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Rate of the wounds, ready for a skin grafting after 4 weeks of the NPWT	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Germany

Contacts

Public ContactBernd Hartmann

BG-Kliniken Umfallkrankenhaus Berlin

bernd.hartmann@ukb.de+493056813501

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026