Clinical trial NCT02771015: Performance of Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip -,Knee- Arthroplasty,Primary Spine Surgery in Comparison to a Standard Wound Dressing
Official title: A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip-arthroplasty
Knee-arthroplasty
Spine Surgery
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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).

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Age ≥18years
2. Have an expected total length of stay of 4 or more days
3. Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
4. Undergoing hip surgery with a standard access
5. Give their written informed consent to participate

Exclusion Criteria:

1. Dressing size does not fit the incision area
2. Known allergy/hypersensitivity to any of the components of the dressing
3. Multi-trauma
4. Undergoing arthroplasty due to tumor
5. Fractures
6. Wound at the surgical site prior to surgery
7. Neurological deficit of operated side (hemiplegia, etc.)
8. Subject has documented skin disease at time of enrolment, as judged by the investigator

Primary outcomes:
measure: Minimize the Risk of the Development of Blistering
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing
timeFrame: 7 days
measure: Comfort, Comformability, Acceptability of the Dressing
timeFrame: 7 days
measure: Change From Baseline in Pain on the visual analog scale
timeFrame: 7 days
measure: the overall cost regarding dressing wear time
timeFrame: 7 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
affiliation: University Hospital Cologne
name: Jan Bredow
role: PRINCIPAL_INVESTIGATOR
References: