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

Not Applicable

Completed

• Conditions: Spine Surgery; Knee-arthroplasty; Hip-arthroplasty
• Interventions: Device: Mepilex Border®; Device: Cosmopor steril®

• Registration Number: NCT02771015
• Lead Sponsor: University of Cologne

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

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-09-08
• Primary Completion: 2015-12
• Status Verified: 2016-05
• Study Completion: 2016-05
• Study First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepilex Border®	Mepilex Border®	Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery
Cosmopor steril®	Cosmopor steril®	Standard wound dressing at patients after hip-knee or primary spine surgery

Primary Outcome Measures

Name	Time	Method
Minimize the Risk of the Development of Blistering	7 days after surgery	Number of participants without blisters at study visit

Secondary Outcome Measures

Name	Time	Method
Comfort, Comformability, Acceptability of the Dressing	7 days	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
Change From Baseline in Pain on the visual analog scale	7 days	Scores range from 0 \[no pain\] to 10 \[worst possible pain\]
the overall cost regarding dressing wear time	7 days	bill of material costs
Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing	7 days	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

Trial Locations

Locations (1)

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany