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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

560

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

April 20, 2017

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed

10 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed

Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

June 6, 2017

Last Update Submit

March 6, 2020

Conditions

Occlusive Dressings Nursing Knee Surgery Hip Surgery

Outcome Measures

Primary Outcomes (1)

Skin integrity
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
2 weeks after surgery

Study Arms (5)

Conventional dressing

ACTIVE COMPARATOR

The conventional dressing (sterile gauzes) will be applied

Device: Conventional dressing

Aquacel Surgical®

EXPERIMENTAL

Postoperative sterile dressing composed by non-woven inner pad (in contact with wound) Technology Hydrofiber® formed from sodium carboxymethylcellulose

Device: Aquacel Surgical®

Mepilex Border post-op®

EXPERIMENTAL

Flexible absorbent all-in-one post-op dressing, super-absorbent fibres for high and fast absorption with optimised retention.

Device: Mepilex Border post-op®

Opsite post-op visible®

EXPERIMENTAL

Adhesive dressing with absorbent foam in the form of a grid to visualize the wound without lifting the dressing

Device: Opsite post-op visible®

Urgotul ABSORB border silicona®

EXPERIMENTAL

A soft-adherent TLC (Technology Lipido-Colloid) layer (polymers and hydrocolloid particles) combined with an absorbent polyurethane foam pad and a highly absorbent layer. A vapour permeable waterproof outer film with silicone adhesive on the edges.

Device: Urgotul ABSORB border silicona®