Clinical trial NCT03190447: Wich is the Best Dressing in Wounds by Primary Surgery of THA and / or TKA?
Official title: Randomized Clinical Trial Comparing 5 Types Dressings in Wounds by Primary Orthopedic Surgery of Total Hip Arthroplasty and / or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusive Dressings
Nursing
Knee Surgery
Hip Surgery
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Fundació Parc Taulí
name: Department of Health, Generalitat de Catalunya
First posted: 2017-06-16
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Skin integrity
timeFrame: 2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
Study officials:
References:
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