The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery

Pressure Injury Clinical Trial

Official title:

The Effect of Pressure Wound Care Package on O.R. Pressure Wound Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852236
• Other study ID #: SehitkamilDH275002727
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2023
• Source: Sehitkamil Devlet Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SUMMARY In a non-randomised (quasi-experimental) clinical study, it was aimed to determine the effect of the care package applied in the early postoperative period on operating theatre pressure sores, pain, fear of falling and comfort in patients undergoing orthopaedic surgery. In the study, the care bundle for pressure injuries was prepared in accordance with the clinical guidelines and was applied to the patients in the study group. This study was conducted in the orthopaedics and traumatology clinic of a public hospital in the Southeastern Anatolia Region of Turkey.

Description:

Medhod:Patients in the control group underwent routine practice of the clinic and this group was observed for 199 days. The care bundle for pressure injuries developed within the scope of the research was not applied. In the study group, in addition to routine clinical practice, the care bundle for pressure injuries developed for this study was applied for 105 days. Since the pressure ulcer originating from the operating room was seen until the 48th-72nd hour, the evaluations and interventions within the scope of the study were performed for three days, considering the operation day as the zeroth day for the control and study groups. A total of 190 patients, 122 in the control group and 68 in the study group, were included in the study.

The care bundle consisted of "skin care, positioning, early mobilization, nutrition, and fluid intake" interventions. In the study, first, the data of the control group and then the data of the study group were collected.

Data Collection Tools: The Patient Descriptive Information Form consists of sociodemographic data. The 3S OR Pressure Injury Risk Assessment Scale was used to identify patients at risk of developing OR pressure ulcers. Visual Analogue Scale was used to evaluate pain perception. The Visual Analog Scale was used to determine the fear of falling. General Comfort Questionnaire-Short Form was used to determine the comfort level. The National Pressure Ulcer Advisory Panel (NPUAP) 2016 Pressure Injury Staging System was used to assess and stage pressure ulcer development. Pressure Injury Areas and Stages Follow-up Registration Form; The form in which the pressure ulcer development status is recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 30, 2022
• Est. primary completion date: January 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

18 years of age or older

• Orthopaedics and traumatology department

• Those who have undergone general or spinal anaesthesia

• No history of surgery in the last month

• Without any communication problems

• 3S Patients with a score of 18 and above on the Operating Theatre Pressure Wound Risk Assessment Scale

• Patients admitted to the emergency clinic, whose trauma-related surgery is planned within 24 hours from the emergency clinic

• Admission to the orthopaedics and traumatology clinic within maximum 24 hours from the day of surgery planned as elective surgery

• Patients who volunteered to participate in the study were included.

Exclusion Criteria:

• I'm the one whose surgery was cancelled

• Those who have undergone local or regional anaesthesia

• Patients referred to the intensive care unit after surgery

• Patients who wanted to leave the study after volunteering were excluded from the study.

Related Conditions & MeSH terms

• Crush Injuries
• Orthopedic Surgery
• Pressure Injury

Intervention

Other:
• Assigned Interventions
Pressure ulcer care package application.

Locations

Country	Name	City	State
Turkey	Sehitkamil Devlet Hastanesi	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Sehitkamil Devlet Hastanesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of pressure ulcer care package on the incidence of pressure ulcers in patients	In this study, it was seen that the pressure ulcer care package applied to the study group contributed positively to the change in the incidence rate of pressure ulcers.	Implementation Time: 3.5 Month
Primary	The effect of pressure ulcer care package on pain perception in patients	In this study, it was seen that the pressure ulcer care package applied to the study group made positive contributions to the change of pain level.; Visual Analog Scale was used to evaluate the level of pain. The score obtained from the scale ranges from one to ten. The higher the score, the higher the level of pain.	Implementation Time: 3.5 Month
Primary	The effect of pressure ulcer care package on fear of falling in patients	In this study, the pressure ulcer care package applied to the study group changed the fear of falling in patients.; Visual Analogue Scale was used to obtain numerical data in the assessment of fear of falling. The score obtained from the scale ranges from one to ten. The higher the score, the greater the fear of falling.	Implementation Time: 3.5 Month
Primary	The effect of pressure ulcer care package on comfort in patients	In this study, the pressure ulcer care package applied to the study group changed the comfort of the patients.; The comfort level of the patients was determined by using the short form of the comfort scale. As the score obtained from the scale increases, the level of comfort increases.	Implementation Time: 3.5 Month