Pressure UlcerNCT06166641
Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients
An observational study of Pressure Ulcer and Predictive Models, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pressure Ulcer, Predictive Models, Surgical Patient
- What is being tested?
- Surgical procedure at operating room
- Type of treatment
- Surgery or procedure
- How many people
- 5,658 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The inclusion and exclusion criteria provided suggest that the study aims to evaluate the clinical characteristic of pressure injury in patients who undergo surgery. The study will include all patients who undergo surgery at the participating setting after study registration. This broad inclusion criteria allows for a diverse patient population to be included in the study.
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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Wu Jiayuan, 86-0759-2387156, wujiay@gdmu.edu.cn
About this study
Official title: Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients: a Multicenter Prospective Cohort Study
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.
Read more
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.
- Conditions
- Pressure Ulcer, Predictive Models, Surgical Patient, Clinical Outcome
- Being tested
- Surgical procedure at operating room
- Keywords
- intraoperatively acquired pressure injury, Pressure Ulcer, predictive models, surgical patient, clinical outcome
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedure at operating roomProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative acquired pressure injury | Intraoperative acquired pressure injury are wounds that develop during a surgical procedure or while a patient is in the operating room. These ulcers are caused by prolonged pressure on a specific area of the body, which reduces blood flow and leads to tissue damage. Receives: Procedure: Surgical procedure at operating room |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative Period
Secondary outcomes (1)
Mortality
All deaths reported in the study population
Measured: Perioperative Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Guangdong Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiyue Zhong, Affiliated Hospital of Guangdong Medical University
- Investigators
- Yiyue Zhong, MD, Principal investigator, Affiliated Hospital of Guangdong Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166641
- Sponsor's protocol ID
- PJKT2023-007
- Status last verified
- Jun 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing policies and decisions are typically determined by the researchers or organizations conducting the study, in collaboration with any relevant ethical review boards and regulatory bodies.
Publications
Dunk AM, Carville K. The international clinical practice guideline for prevention and treatment of pressure ulcers/injuries. J Adv Nurs. 2016 Feb;72(2):243-4. doi: 10.1111/jan.12614. Epub 2015 Jan 6. No abstract available.
PubMed 25558893Xiong 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.
PubMed 30375697Nixon J, Brown J, McElvenny D, Mason S, Bond S. Prognostic factors associated with pressure sore development in the immediate post-operative period. Int J Nurs Stud. 2000 Aug;37(4):279-89. doi: 10.1016/s0020-7489(99)00059-0.
PubMed 10760535Gillespie 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: 10.1016/j.ijnurstu.2021.103976. Epub 2021 May 18.
PubMed 34090235Gillespie 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.
PubMed 32484259Gallagher P, Barry P, Hartigan I, McCluskey P, O'Connor K, O'Connor M. Prevalence of pressure ulcers in three university teaching hospitals in Ireland. J Tissue Viability. 2008 Nov;17(4):103-9. doi: 10.1016/j.jtv.2007.12.001. Epub 2008 Apr 18.
PubMed 18378140Vazykhova FG, Viazov SO, Anan'ev VA. [Polypeptide composition of the delta-antigen]. Vopr Virusol. 1989 May-Jun;34(3):299-302. Russian.
PubMed 2477952Labeau 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; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Correction to: Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Apr;47(4):503-520. doi: 10.1007/s00134-020-06327-5. No abstract available.
PubMed 33635356Nguyen HL, Vu VC, Nguyen DL, Vo HL, Nguyen QD. Posterior surgical approach for the treatment of lower cervical spine injury with spinal cord paralysis: high postoperative mortality in resource-scare setting. Eur Rev Med Pharmacol Sci. 2022 Apr;26(8):2960-2969. doi: 10.26355/eurrev_202204_28627.
PubMed 35503640Hopkins A, Dealey C, Bale S, Defloor T, Worboys F. Patient stories of living with a pressure ulcer. J Adv Nurs. 2006 Nov;56(4):345-53. doi: 10.1111/j.1365-2648.2006.04007.x.
PubMed 17042814Khor 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.
PubMed 25091603Manzano 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 Eval Clin Pract. 2014 Aug;20(4):362-8. doi: 10.1111/jep.12137. Epub 2014 May 22.
PubMed 24854297Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure Ulcers in the United States' Inpatient Population From 2008 to 2012: Results of a Retrospective Nationwide Study. Ostomy Wound Manage. 2016 Nov;62(11):30-38.
PubMed 27861135EXTON-SMITH AN, SHERWIN RW. The prevention of pressure sores. Significance of spontaneous bodily movements. Lancet. 1961 Nov 18;2(7212):1124-6. doi: 10.1016/s0140-6736(61)91033-9. No abstract available.
PubMed 13891095Waterlow J. Pressure sores: a risk assessment card. Nurs Times. 1985 Nov 27-Dec 3;81(48):49-55. No abstract available.
PubMed 3853163
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Models for Risk Score and Prognosis of Intraoperatively Acquired Pressure Injury in Surgical Patients: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06166641
- Acronym / sponsor ID
- PJKT2023-007
- Conditions
- Pressure Ulcer, Predictive Models, Surgical Patient, Clinical Outcome
- Keywords
- intraoperatively acquired pressure injury, Pressure Ulcer, predictive models, surgical patient, clinical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,658 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Guangdong Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative acquired pressure injury | – | Procedure: Surgical procedure at operating roomIntraoperative acquired pressure injury are wounds that develop during a surgical procedure or while a patient is in the operating room. These ulcers are caused by prolonged pressure on a specific area of the body, which reduces blood flow and leads to tissue damage. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The inclusion and exclusion criteria provided suggest that the study aims to evaluate the clinical characteristic of pressure injury in patients who undergo surgery. The study will include all patients who undergo surgery at the participating setting after study registration. This broad inclusion criteria allows for a diverse patient population to be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical procedure at operating roomA 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. | Procedure or surgery | Intraoperative acquired pressure injury |
Primary outcome
Intraoperative acquired pressure injury
Time frame: Perioperative Period
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.
1 secondary outcome
Mortality
Time frame: Perioperative Period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Results publication: PubMed 25558893Dunk AM, Carville K. The international clinical practice guideline for prevention and treatment of pressure ulcers/injuries. J Adv Nurs. 2016 Feb;72(2):243-4. doi: 10.1111/jan.12614. Epub 2015 Jan 6. No abstract available.
- Results publication: PubMed 30375697Xiong 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.
- Results publication: PubMed 10760535Nixon J, Brown J, McElvenny D, Mason S, Bond S. Prognostic factors associated with pressure sore development in the immediate post-operative period. Int J Nurs Stud. 2000 Aug;37(4):279-89. doi: 10.1016/s0020-7489(99)00059-0.
- Results publication: PubMed 34090235Gillespie 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: 10.1016/j.ijnurstu.2021.103976. Epub 2021 May 18.
- Results publication: PubMed 32484259Gillespie 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.
- Results publication: PubMed 18378140Gallagher P, Barry P, Hartigan I, McCluskey P, O'Connor K, O'Connor M. Prevalence of pressure ulcers in three university teaching hospitals in Ireland. J Tissue Viability. 2008 Nov;17(4):103-9. doi: 10.1016/j.jtv.2007.12.001. Epub 2008 Apr 18.
- Results publication: PubMed 2477952Vazykhova FG, Viazov SO, Anan'ev VA. [Polypeptide composition of the delta-antigen]. Vopr Virusol. 1989 May-Jun;34(3):299-302. Russian.
- Results publication: PubMed 33635356Labeau 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; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Correction to: Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Apr;47(4):503-520. doi: 10.1007/s00134-020-06327-5. No abstract available.
- Results publication: PubMed 35503640Nguyen HL, Vu VC, Nguyen DL, Vo HL, Nguyen QD. Posterior surgical approach for the treatment of lower cervical spine injury with spinal cord paralysis: high postoperative mortality in resource-scare setting. Eur Rev Med Pharmacol Sci. 2022 Apr;26(8):2960-2969. doi: 10.26355/eurrev_202204_28627.
- Results publication: PubMed 17042814Hopkins A, Dealey C, Bale S, Defloor T, Worboys F. Patient stories of living with a pressure ulcer. J Adv Nurs. 2006 Nov;56(4):345-53. doi: 10.1111/j.1365-2648.2006.04007.x.
- Results publication: PubMed 25091603Khor 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.
- Results publication: PubMed 24854297Manzano 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 Eval Clin Pract. 2014 Aug;20(4):362-8. doi: 10.1111/jep.12137. Epub 2014 May 22.
- Individual participant dataSharing planned: Undecided. The data sharing policies and decisions are typically determined by the researchers or organizations conducting the study, in collaboration with any relevant ethical review boards and regulatory bodies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiyue Zhong, MD principal investigator
Affiliated Hospital of Guangdong Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer and Predictive Models, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiyue Zhong, MD (13726909905, zyy0803@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative acquired pressure injury (time frame: Perioperative Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06166641, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.