Pressure Ulcers in Knee Replacement Surgery

Completed

• Conditions: Knee Osteoarthritis; Pressure Ulcer

• Registration Number: NCT03039153
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

From the point of view of nursing to know exactly the different risk factors for the onset of pressure ulcers is very important as it allows to accurately orient preventive care interventions.

All the variable that could influence the development of pressure ulcer in patients undergoing knee replacement surgery are identified and collected: age, sex, body max index, risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology of the devices used, such as air mattresses with alternating or static pressure, heel drains, frequency of mobilization carried out by both the patient care), management of eventual incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia, length of stay, the ASA physical status classification system (ASA score), comorbidity, cancer, use of devices for controlling the position of the operated limb (foam valve), the number of physical therapy sessions actually carried out.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Study Start: 2017-03-21
• Primary Completion: 2017-12-13
• Study Completion: 2017-12-13
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

Inclusion Criteria

• Primary knee joint replacement
• Secondary knee joint replacement

Exclusion Criteria

• Cancer patients
• Adult or Senior with pressure ulcer at the heel

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heel Pressure Sores	every day until discharge (expected average of 6 days).	Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.

Secondary Outcome Measures

Name	Time	Method
Pain	up to the first 3 days post intervention	Pain Score on the "Numeric Rating Scale (NRS)". The NRS scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain
Heel Pressure Sores of grade ≥2	every day until discharge (expected average of 6 days).	Numbers of Participants With Heel Pressure Sores of grade ≥2 Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
Pressure Sores in any other site	every day until discharge (expected average of 6 days).	Numbers of Participants With Pressure Sores in any other site Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy