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

NCT ID: NCT02771015

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-05-31

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

Conditions

Hip-arthroplasty; Knee-arthroplasty; Spine Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Mepilex Border®

Mepilex Border® wound dressing at patients after hip-knee or primary spine surgery

Group Type: ACTIVE_COMPARATOR

Mepilex Border®

Intervention Type: DEVICE

randomization

Cosmopor steril®

Standard wound dressing at patients after hip-knee or primary spine surgery

Group Type: ACTIVE_COMPARATOR

Cosmopor steril®

Intervention Type: DEVICE

randomization

Interventions

Mepilex Border®

randomization

Intervention Type: DEVICE

Cosmopor steril®

randomization

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Jan Bredow

Dr.med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Bredow

Role: PRINCIPAL_INVESTIGATOR

University Hospital Cologne

Locations

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

Uni-Köln_2013-01

Identifier Type: -

Identifier Source: org_study_id