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Completed

NCT Number: NCT03190447

Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?

Surgical wounds are covered to prevent bleeding, absorb the exudates and provide a barrier against external contamination. Currently, in Corporació PT after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. In many cases the appearance of blistering caused by the use of these conventional dressings is observed, which increases the risk of infection, pain and the final cost of the procedure. There are other types of dressings that could improve these aspects but comparative data are not currently available. Main objective: to identify the dressing that better preserves the integrity of the skin.

Design: Prospective randomized comparative study of 5 types of dressings used in total knee and hip arthroplasty surgical wounds (TKA and THA).

Secondary Objectives: To identify the dressing that provides greater advantages and minor inconveniences in TKA and THA surgery.

Study population: Patients older than 18 years undergoing fast track primary TKA or THA. 110 patients

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Key information

Conditions

Occlusive Dressings Hip Surgery Knee Surgery Nursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients older than 18 years
  • operated on primary TKA and THA in the fast track circuit
  • adequate cognitive ability.

Exclusion criteria

  • damaged skin
  • no self-care capacity or caregiver
  • inadequate cognitive ability to consent freely
  • patients who will not undergo "fast track" surgery

Treatment and study plan

Aquacel Surgical®

Device

Measuring the skin integrity with each dressing and the patient satisfaction

Mepilex Border post-op®

Device

Measuring the skin integrity with each dressing and the patient satisfaction

Opsite post-op visible®

Device

Measuring the skin integrity with each dressing and the patient satisfaction

Urgotul ABSORB border silicona®

Device

Measuring the skin integrity with each dressing and the patient satisfaction

Conventional dressing

Device

Measuring the skin integrity with each dressing and the patient satisfaction

Primary outcomes

  1. Skin integrity

    Time frame: 2 weeks after surgery

    Skin integrity is a composite endpoint including absence of any of the following items: blisters, erosion, erythema, maceration, swelling, wound dehiscence, purulent exudate) in the area of the surgical wound, measured by wound inspection

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Department of Health, Generalitat de Catalunya
  • Fundació Parc Taulí

Registry information

Official study title

Randomized Clinical Trial Comparing 5 Types Dressings in Wounds by Primary Orthopedic Surgery of Total Hip Arthroplasty and / or Knee

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2017
Registry last updated
Mar 9, 2020

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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