Clinical trial NCT05852236: The Effect of Pressure Wound Care Package on the Development of Operating Room Pressure Wound in Orthopedic Surgery
Official title: The Effect of Pressure Wound Care Package on O.R. Pressure Wound Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Orthopedic Surgery
Keywords: orthopedic surgery
pressure injury
care bundle
pain
fear of falling
comfort
Lead sponsor: Sehitkamil Devlet Hastanesi
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of pressure ulcer care package on the incidence of pressure ulcers in patients
timeFrame: Implementation Time: 3.5 Month
measure: The effect of pressure ulcer care package on pain perception in patients
timeFrame: Implementation Time: 3.5 Month
measure: The effect of pressure ulcer care package on fear of falling in patients
timeFrame: Implementation Time: 3.5 Month
measure: The effect of pressure ulcer care package on comfort in patients
timeFrame: Implementation Time: 3.5 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Şehitkamil Devlet Hastanesi
Study officials:
affiliation: Prefessor
name: Ayla YAVA, PhD
role: STUDY_DIRECTOR
References: