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CompletedNCT05852236Updated May 10, 2023

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

An interventional study of Assigned Interventions in Pressure Injury and Orthopedic Surgery, sponsored by Sehitkamil Devlet Hastanesi. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by Sehitkamil Devlet Hastanesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jul 2021, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pressure Injury
  • Orthopedic Surgery

Keywords

  • orthopedic surgery
  • pressure injury
  • care bundle
  • pain
  • fear of falling
  • comfort
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 190 is above the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

This is the only study on the registry with Sehitkamil Devlet Hastanesi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    Control Group

    The standard care of the clinic was applied to the control group.

    Other: Assigned Interventions

  • Experimental
    Study Group

    The pressure ulcer care package developed for this study was applied to the study group.

    Other: Assigned Interventions

Interventions

  • OtherAssigned Interventions

    Pressure ulcer care package application.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Implementation Time: 3.5 Month

  2. 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.

    Time frame: Implementation Time: 3.5 Month

  3. 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.

    Time frame: Implementation Time: 3.5 Month

  4. 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.

    Time frame: Implementation Time: 3.5 Month

07

Study locations

1 site
  • Şehitkamil Devlet Hastanesi
    Gaziantep, 27500, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05852236
Lead sponsor
Sehitkamil Devlet Hastanesi
Responsible party
Hatice Eğilmez (Nurse, RN, Sehitkamil Devlet Hastanesi) — Principal investigator
First posted
May 10, 2023
Start date
Jul 1, 2021
Primary completion
Jan 16, 2022
Completion
Apr 30, 2022
Last update
May 10, 2023

Study contacts

Ayla YAVA, PhD
study director · Prefessor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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