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Completed

NCT Number: 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

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).

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Key information

Conditions

Hip-arthroplasty Knee-arthroplasty Spine Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mepilex Border®

Device

randomization

Cosmopor steril®

Device

randomization

Primary outcomes

  1. Minimize the Risk of the Development of Blistering

    Time frame: 7 days after surgery

    Number of participants without blisters at study visit

Secondary outcomes

  1. Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing

    Time frame: 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

  2. Comfort, Comformability, Acceptability of the Dressing

    Time frame: 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

  3. Change From Baseline in Pain on the visual analog scale

    Time frame: 7 days

    Scores range from 0 [no pain] to 10 [worst possible pain]

  4. the overall cost regarding dressing wear time

    Time frame: 7 days

    bill of material costs

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study 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)

Acronym: wounddressing

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 12, 2016
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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