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 (wounddressing)

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)

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).

Study Overview

• Status: Completed
• Conditions: Spine Surgery; Hip-arthroplasty; Knee-arthroplasty
• Intervention / Treatment: Device: Mepilex Border®; Device: Cosmopor steril®

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50931
      • University Hospital Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Mepilex Border®; Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery	Device: Mepilex Border®; randomization
ACTIVE_COMPARATOR: Cosmopor steril®; Standard wound dressing at patients after hip-knee or primary spine surgery	Device: Cosmopor steril®; randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimize the Risk of the Development of Blistering	Number of participants without blisters at study visit	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	7 days
Change From Baseline in Pain on the visual analog scale	Scores range from 0 [no pain] to 10 [worst possible pain]	7 days
the overall cost regarding dressing wear time	bill of material costs	7 days

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Jan Bredow, University Hospital Cologne

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (ESTIMATE): May 12, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Uni-Köln_2013-01