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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03190447
Enrollment
560
Registered
2017-06-16
Start date
2017-04-20
Completion date
2019-12-31
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusive Dressings, Nursing, Knee Surgery, Hip Surgery

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

Interventions

DEVICEAquacel Surgical®

Measuring the skin integrity with each dressing and the patient satisfaction

DEVICEMepilex Border post-op®

Measuring the skin integrity with each dressing and the patient satisfaction

DEVICEOpsite post-op visible®

Measuring the skin integrity with each dressing and the patient satisfaction

DEVICEUrgotul ABSORB border silicona®

Measuring the skin integrity with each dressing and the patient satisfaction

Measuring the skin integrity with each dressing and the patient satisfaction

Sponsors

Fundació Parc Taulí
CollaboratorUNKNOWN
Department of Health, Generalitat de Catalunya
CollaboratorOTHER_GOV
Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Skin integrity2 weeks after surgerySkin 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026