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

Not Applicable

Completed

• Conditions: Hip Surgery; Nursing; Occlusive Dressings; Knee Surgery
• Interventions: Device: Mepilex Border post-op®; Device: Conventional dressing; Device: Urgotul ABSORB border silicona®; Device: Aquacel Surgical®; Device: Opsite post-op visible®

• Registration Number: NCT03190447
• Lead Sponsor: Corporacion Parc Tauli

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepilex Border post-op®	Mepilex Border post-op®	Flexible absorbent all-in-one post-op dressing, super-absorbent fibres for high and fast absorption with optimised retention.
Conventional dressing	Conventional dressing	The conventional dressing (sterile gauzes) will be applied
Urgotul ABSORB border silicona®	Urgotul ABSORB border silicona®	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.
Aquacel Surgical®	Aquacel Surgical®	Postoperative sterile dressing composed by non-woven inner pad (in contact with wound) Technology Hydrofiber® formed from sodium carboxymethylcellulose
Opsite post-op visible®	Opsite post-op visible®	Adhesive dressing with absorbent foam in the form of a grid to visualize the wound without lifting the dressing

Primary Outcome Measures

Name	Time	Method
Skin integrity	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

Trial Locations

Locations (1)

Corporació Sanitaria Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain