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

Corporacion Parc Tauli

Status: Completed

Conditions: Hip Surgery; Knee Surgery; Occlusive Dressings; Nursing

Treatments: Device: Conventional dressing; Device: Mepilex Border post-op®; Device: Urgotul ABSORB border silicona®; Device: Opsite post-op visible®; Device: Aquacel Surgical®

Study type: Interventional

Funder types: Other

Identifiers

NCT03190447

ENF_APO_2017

Details and patient eligibility

About

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

Enrollment: 560 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 5 patient groups

Conventional dressing

Active Comparator group

Description:

The conventional dressing (sterile gauzes) will be applied

Treatment:

Device: Conventional dressing

Aquacel Surgical®

Experimental group

Description:

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

Treatment:

Device: Aquacel Surgical®

Mepilex Border post-op®

Experimental group

Description:

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

Treatment:

Device: Mepilex Border post-op®

Opsite post-op visible®

Experimental group

Description:

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

Treatment:

Device: Opsite post-op visible®

Urgotul ABSORB border silicona®

Experimental group

Description:

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.

Treatment:

Device: Urgotul ABSORB border silicona®