Pressure Ulcer Clinical Trial
Official title:
Post-market Clinical Follow-up Study to Evaluate the Performance and Safety of Suprasorb® A + Ag Wound Dressing and Rope in the Treatment of Wounds at Risk of Infection and Infected Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.
This clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. All wounds of the included patients will be treated with Suprasorb® A +Ag Antimicrobial Calcium Alginate Wound Dressings (and Suprasorb® A + Ag Antimicrobial Calcium Packing Rope - if required by the depth of the wound). At inclusion visit (V1, day 0), interim visit (V2, after 10 days ±3 days) and termination visit (V3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have clinical examination and wound area measurements. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03351049 -
An RCT on Support Surfaces for Pressure Ulcer Prevention
|
N/A | |
| Completed |
NCT05112068 -
Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
|
||
| Completed |
NCT05575869 -
Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
|
N/A | |
| Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
| Recruiting |
NCT04540822 -
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
|
N/A | |
| Terminated |
NCT05234632 -
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
|
N/A | |
| Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
| Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
| Completed |
NCT01438541 -
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
|
Phase 4 | |
| Completed |
NCT00365430 -
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
|
N/A | |
| Completed |
NCT04251897 -
Novel Support Surface to Alleviate Pressure Ulcer
|
N/A | |
| Completed |
NCT03391310 -
Use of Honey for Pressure Ulcers in Critically Ill Children
|
N/A | |
| Recruiting |
NCT04559165 -
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
|
N/A | |
| Terminated |
NCT05547191 -
Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
|
N/A | |
| Completed |
NCT05458050 -
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
|
N/A | |
| Active, not recruiting |
NCT03048357 -
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
|
N/A | |
| Completed |
NCT06025370 -
Pressures During Prone Positions in Healthy Volunteers
|
N/A | |
| Recruiting |
NCT05033470 -
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
|
N/A | |
| Terminated |
NCT04023981 -
Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
|
N/A | |
| Completed |
NCT04265170 -
Evaluating Blast-X® in Combination With Negative Pressure Wound Therapy
|
N/A |