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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06166641
Other study ID # PJKT2023-007
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Affiliated Hospital of Guangdong Medical University
Contact Yiyue Zhong, MD
Phone 13726909905
Email zyy0803@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to effectively identify the risk of intraoperative acquired pressure injuries (IAPI) in surgical patients through a prospective multicenter approach. It combines indicators from commonly used assessment tools and practical experience judgments to construct a comprehensive assessment framework. By incorporating various indicators, the study aims to improve the accuracy and reliability of identifying patients at risk of IAPI during surgery. This will help clinicians in making informed decisions and implementing preventive measures to minimize the occurrence of pressure injuries. The multicenter approach ensures a diverse and representative sample of patients from different surgical settings. This increases the generalizability of the study findings and enhances the applicability of the assessment framework across various clinical settings. The project's methodology involves collecting data on patient demographics, medical history, surgical procedure details, and assessment tool scores. These data points will be analyzed to identify significant risk factors for IAPI and develop a risk prediction model. The study also takes into consideration practical experience judgments, which acknowledge the importance of clinical expertise in assessing patients' risk of IAPI. This ensures that the assessment framework is not solely reliant on assessment tools but also incorporates the insights of experienced clinicians. Overall, this prospective multicenter study aims to contribute to the field by providing a comprehensive and practical approach to identify the risk of IAPI in surgical patients. The findings from this study can be utilized in clinical practice to improve patient outcomes and reduce the incidence of pressure injuries during surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 5658
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria: All patients who underwent surgery procedure at the participating setting after the study registration. Exclusion criteria: Patients who have already been diagnosed with pressure injury (stage II and above) before undergoing surgery procedure. Patients/relatives/guardians understand the refusal of data to be used for clinically relevant research. Investigators believe that certain patient conditions may affect the efficacy and safety assessment of this study.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgical procedure at operating room
A surgical procedure in an operating room is a medical intervention that involves making incisions or using minimally invasive techniques to treat a specific condition or perform a diagnostic procedure. The operating room, also known as the operating theater or surgical suite, is a sterile environment specifically designed to minimize the risk of infection and ensure the safety of both the patient and the surgical team.

Locations

Country Name City State
China The Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Affiliated Hospital of Guangdong Medical University

Country where clinical trial is conducted

China, 

References & Publications (41)

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Gillespie BM, Walker RM, Latimer SL, Thalib L, Whitty JA, McInnes E, Chaboyer WP. Repositioning for pressure injury prevention in adults. Cochrane Database Syst Rev. 2020 Jun 2;6(6):CD009958. doi: 10.1002/14651858.CD009958.pub3. — View Citation

Gillespie BM, Walker RM, Latimer SL, Thalib L, Whitty JA, McInnes E, Lockwood I, Chaboyer WP. Repositioning for pressure injury prevention in adults: An abridged Cochrane systematic review and meta-analysis. Int J Nurs Stud. 2021 Aug;120:103976. doi: 10.1 — View Citation

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Gul A, Sengul T, Yavuz HO. Assessment of the risk of pressure ulcer during the perioperative period: Adaptation of the Munro scale to Turkish. J Tissue Viability. 2021 Nov;30(4):559-565. doi: 10.1016/j.jtv.2021.06.009. Epub 2021 Jul 1. — View Citation

Guo Y, Zhao K, Zhao T, Li Y, Yu Y, Kuang W. The effectiveness of curvilinear supine position on the incidence of pressure injuries and interface pressure among surgical patients. J Tissue Viability. 2019 May;28(2):81-86. doi: 10.1016/j.jtv.2019.02.005. Ep — View Citation

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Jun Seongsook RN, Jeong Ihnsook RN, Lee Younghee RN. Validity of pressure ulcer risk assessment scales; Cubbin and Jackson, Braden, and Douglas scale. Int J Nurs Stud. 2004 Feb;41(2):199-204. doi: 10.1016/s0020-7489(03)00135-4. — View Citation

Khor HM, Tan J, Saedon NI, Kamaruzzaman SB, Chin AV, Poi PJ, Tan MP. Determinants of mortality among older adults with pressure ulcers. Arch Gerontol Geriatr. 2014 Nov-Dec;59(3):536-41. doi: 10.1016/j.archger.2014.07.011. Epub 2014 Jul 21. — View Citation

Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, Francois G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubI — View Citation

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Lei L, Zhou T, Xu X, Wang L. Munro Pressure Ulcer Risk Assessment Scale in Adult Patients Undergoing General Anesthesia in the Operating Room. J Healthc Eng. 2022 Mar 21;2022:4157803. doi: 10.1155/2022/4157803. eCollection 2022. — View Citation

Manzano F, Perez-Perez AM, Martinez-Ruiz S, Garrido-Colmenero C, Roldan D, Jimenez-Quintana Mdel M, Sanchez-Cantalejo E, Colmenero M. Hospital-acquired pressure ulcers and risk of hospital mortality in intensive care patients on mechanical ventilation. J — View Citation

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Schoonhoven L, Haalboom JR, Bousema MT, Algra A, Grobbee DE, Grypdonck MH, Buskens E; prePURSE study group. The prevention and pressure ulcer risk score evaluation study. Prospective cohort study of routine use of risk assessment scales for prediction of — View Citation

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International C — View Citation

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Wang LH, Chen HL, Yan HY, Gao JH, Wang F, Ming Y, Lu L, Ding JJ. Inter-rater reliability of three most commonly used pressure ulcer risk assessment scales in clinical practice. Int Wound J. 2015 Oct;12(5):590-4. doi: 10.1111/iwj.12376. Epub 2014 Sep 16. — View Citation

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Waterlow J. Tissue viability. Prevention is cheaper than cure. Nurs Times. 1988 Jun 22-28;84(25):69-70. No abstract available. — View Citation

Xiong C, Gao X, Ma Q, Yang Y, Wang Z, Yu W, Yu L. Risk factors for intraoperative pressure injuries in patients undergoing digestive surgery: A retrospective study. J Clin Nurs. 2019 Apr;28(7-8):1148-1155. doi: 10.1111/jocn.14712. Epub 2018 Dec 7. — View Citation

* Note: There are 41 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative acquired pressure injury Intraoperative acquired pressure injuries, also known as intraoperative pressure ulcers or surgical pressure injuries, are wounds that develop during a surgical procedure. These injuries occur due to prolonged pressure on specific areas of the body, which disrupts blood flow and leads to tissue damage. Perioperative Period
Secondary Mortality All deaths reported in the study population Perioperative Period
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