Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
At the baseline visit: * Subject demographic details * Inclusion and exclusion criteria * Vital signs * Medical and surgical history * Skin status at incision site * Mobilisation (subject mobility, mobilisation in bed and chair) * Medication * AE/ADE/ SAE/SADE/DD * Informed consent * Randomization At visit 2: * Type of surgery * Length of incision * Intraoperative antibiotic given * Length of anesthesia At each visit from visit 3: * Surgical incision condition (condition under the dressing, condition outside the dressing, exudates amount, exudates nature, wound odour, dressing capacity of handling blood, signs of systemic infection, systemic antibiotic given for the systematic infection, blistering, skin stripping * Skin status at incision site (type of skin, skin temperature, skin perspiration, oedema, tissue consistency, sensation) * Mobilisation (subject mobility, mobilisation in bed and chair) * Dressing change (application and removal) * Drainage (drainage used, application of the drainage) * Compression Medication (pain medication and systematic antibiotic treatment) * Photo (photo before and after dressing removal and if signs of infection) * Investigator/nurse evaluation (ease of application of the dressing, size of the dressing, shape of the dressing, visibility beneath the dressing, notice any pain at dressing change, ease of removal of the dressing, overall experience) * Patient evaluation (the patient's overall experience of the dressing, comfort when wearing the dressing). * Contentious pain - measured by Visual Analog Scale (VAS) Prüfplan: CLOSE 2.0F 28.10.2013 5(40) * Product application (time application start, time application ended, staff involved, material) * AE/ADE/SAE/SADE/DD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
200
randomization
randomization
University Hospital Cologne
Cologne, North Rhine-Westphalia, Germany
Minimize the Risk of the Development of Blistering
Number of participants without blisters at study visit
Time frame: 7 days after surgery
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing
The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery
Time frame: 7 days
Comfort, Comformability, Acceptability of the Dressing
The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent
Time frame: 7 days
Change From Baseline in Pain on the visual analog scale
Scores range from 0 \[no pain\] to 10 \[worst possible pain\]
Time frame: 7 days
the overall cost regarding dressing wear time
bill of material costs
Time frame: 7 days
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