CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 560 enrolled
Drug / intervention
Aquacel Surgical® +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03190447
NCT03190447N/ACompleted

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

Corporacion Parc Tauli·interventional·Posted Jun 16, 2017·Updated Mar 9, 2020

In Brief

A clinical study evaluating Aquacel Surgical®, Mepilex Border post-op®, and 3 other interventions for Occlusive Dressings and 3 related conditions. Completed, enrolled 560 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 16, 2017
Enrollment StartApr 20, 2017
Primary CompletionDec 30, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.0 years ago

Interventions

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 dressingdevice

Measuring the skin integrity with each dressing and the patient satisfaction