Pressure InjuryNCT06316726
The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury
A study testing full bed silicone mattress plus other measures in people with Pressure Injury and Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Surgery
- What is being tested?
- full bed silicone mattress plus other measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2021to 31 Aug 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 and more years old
- Over 4 hours lying flat on the operating table (eg., orthognathic surgery, microtia reconstruction surgery, etc.)
- Those who are conscious clearly and can communicate in Mandarin and Taiwanese
- Those with agree to participate in this study
Who cannot join
- Those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc.
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Two Nursing Programs on the Surgery-Related Pressure Injury in Surgery Patients
Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.
Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries.
- Conditions
- Pressure Injury, Surgery
- Being tested
- full bed silicone mattress plus other measures
- Keywords
- surgery-related pressure injury, incidence, grade, sites, time
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full bed silicone mattress plus other measuresCombination product
full bed silicone mattress plus put silicone pads on the head and shoulders, cotton rolls wraps bony prominence (elbows and heels), petrissage every two hours on shoulders to fingers and lower legs to heels, change location of ankle pads, use round gel full of air sit pad, a pillow on the knees
| Study group | Role | What they receive |
|---|---|---|
| intervention A | Active comparator | full bed silicone mattress plus other measures Receives: Combination Product: full bed silicone mattress plus other measures |
| intervention B | No intervention | full bed silicone mattress plus usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of surgery-related pressure injuries
incidence, grade, site, and time of surgery-related pressure injuries
Measured: baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Dec 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Chu Tsai, MN, Study director, Nursing Department of Taoyuan Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316726
- Sponsor's protocol ID
- 202100409A3
- Status last verified
- May 2021
- First submitted
- 29 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nixon J, McElvenny D, Mason S, Brown J, Bond S. A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Int J Nurs Stud. 1998 Aug;35(4):193-203. doi: 10.1016/s0020-7489(98)00023-6.
PubMed 9801935Feuchtinger J, de Bie R, Dassen T, Halfens R. A 4-cm thermoactive viscoelastic foam pad on the operating room table to prevent pressure ulcer during cardiac surgery. J Clin Nurs. 2006 Feb;15(2):162-7. doi: 10.1111/j.1365-2702.2006.01293.x.
PubMed 16422733Sewchuk D, Padula C, Osborne E. Prevention and early detection of pressure ulcers in patients undergoing cardiac surgery. AORN J. 2006 Jul;84(1):75-96. doi: 10.1016/s0001-2092(06)60100-2.
PubMed 16881492Donnelly J, Winder J, Kernohan WG, Stevenson M. An RCT to determine the effect of a heel elevation device in pressure ulcer prevention post-hip fracture. J Wound Care. 2011 Jul;20(7):309-12, 314-8. doi: 10.12968/jowc.2011.20.7.309.
PubMed 21841719Oliveira KF, Pires PDS, De-Mattia AL, Barichello E, Galvao CM, Araujo CA, Barbosa MH. Influence of support surfaces on the distribution of body interface pressure in surgical positioning. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3083. doi: 10.1590/1518-8345.2692.3083.
PubMed 30517574Joseph J, McLaughlin D, Darian V, Hayes L, Siddiqui A. Alternating Pressure Overlay for Prevention of Intraoperative Pressure Injury. J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):13-17. doi: 10.1097/WON.0000000000000497.
PubMed 30601427Neo TG, Koo SH, Chew STH, Png GK, Lacuesta MJ, Wu MYL, Tay RYC, Singh PA, Chandran R. A randomized controlled trial to compare the interface pressures of alternating pressure overlay with gel pad versus gel pad alone during prolonged surgery. J Tissue Viability. 2021 May;30(2):222-230. doi: 10.1016/j.jtv.2021.02.003. Epub 2021 Feb 6.
PubMed 33612359Ahmad B, Rubio-Sefati M, Yacob MM. Incidence and risk factors for pressure injuries in patients who have undergone vascular operations: a scoping review. Eur J Med Res. 2023 Feb 13;28(1):77. doi: 10.1186/s40001-023-01036-3.
PubMed 36782315Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012 Sep;24(9):234-41.
PubMed 25874704
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Two Nursing Programs on the Surgery-Related Pressure Injury in Surgery Patients
- ClinicalTrials.gov ID
- NCT06316726
- Acronym / sponsor ID
- 202100409A3
- Conditions
- Pressure Injury, Surgery
- Keywords
- surgery-related pressure injury, incidence, grade, sites, time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Mar 2024 (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.
Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.
Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care).
| Arm | Type | Receives |
|---|---|---|
| intervention A | Active comparator | Combination Product: full bed silicone mattress plus other measuresfull bed silicone mattress plus other measures |
| intervention B | No intervention | –full bed silicone mattress plus usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 and more years old
- Over 4 hours lying flat on the operating table (eg., orthognathic surgery, microtia reconstruction surgery, etc.)
- Those who are conscious clearly and can communicate in Mandarin and Taiwanese
- Those with agree to participate in this study
Key exclusion criteria (2 listed)
- Those whose skin is red, swollen, hot, painful, redness, rash, purple spots, bruising, scaly skin, damaged, etc.
- Refuse to participate 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 |
|---|---|---|
| full bed silicone mattress plus other measuresfull bed silicone mattress plus put silicone pads on the head and shoulders, cotton rolls wraps bony prominence (elbows and heels), petrissage every two hours on shoulders to fingers and lower legs to heels, change location of ankle pads, use round gel full of air sit pad, a pillow on the knees | Combination product | intervention A |
Primary outcome
the occurrence of surgery-related pressure injuries
Time frame: baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl
incidence, grade, site, and time of surgery-related pressure injuries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 9801935Nixon J, McElvenny D, Mason S, Brown J, Bond S. A sequential randomised controlled trial comparing a dry visco-elastic polymer pad and standard operating table mattress in the prevention of post-operative pressure sores. Int J Nurs Stud. 1998 Aug;35(4):193-203. doi: 10.1016/s0020-7489(98)00023-6.
- Results publication: PubMed 16422733Feuchtinger J, de Bie R, Dassen T, Halfens R. A 4-cm thermoactive viscoelastic foam pad on the operating room table to prevent pressure ulcer during cardiac surgery. J Clin Nurs. 2006 Feb;15(2):162-7. doi: 10.1111/j.1365-2702.2006.01293.x.
- Results publication: PubMed 16881492Sewchuk D, Padula C, Osborne E. Prevention and early detection of pressure ulcers in patients undergoing cardiac surgery. AORN J. 2006 Jul;84(1):75-96. doi: 10.1016/s0001-2092(06)60100-2.
- Results publication: PubMed 21841719Donnelly J, Winder J, Kernohan WG, Stevenson M. An RCT to determine the effect of a heel elevation device in pressure ulcer prevention post-hip fracture. J Wound Care. 2011 Jul;20(7):309-12, 314-8. doi: 10.12968/jowc.2011.20.7.309.
- Results publication: PubMed 30517574Oliveira KF, Pires PDS, De-Mattia AL, Barichello E, Galvao CM, Araujo CA, Barbosa MH. Influence of support surfaces on the distribution of body interface pressure in surgical positioning. Rev Lat Am Enfermagem. 2018 Nov 29;26:e3083. doi: 10.1590/1518-8345.2692.3083.
- Results publication: PubMed 30601427Joseph J, McLaughlin D, Darian V, Hayes L, Siddiqui A. Alternating Pressure Overlay for Prevention of Intraoperative Pressure Injury. J Wound Ostomy Continence Nurs. 2019 Jan/Feb;46(1):13-17. doi: 10.1097/WON.0000000000000497.
- Results publication: PubMed 33612359Neo TG, Koo SH, Chew STH, Png GK, Lacuesta MJ, Wu MYL, Tay RYC, Singh PA, Chandran R. A randomized controlled trial to compare the interface pressures of alternating pressure overlay with gel pad versus gel pad alone during prolonged surgery. J Tissue Viability. 2021 May;30(2):222-230. doi: 10.1016/j.jtv.2021.02.003. Epub 2021 Feb 6.
- Results publication: PubMed 36782315Ahmad B, Rubio-Sefati M, Yacob MM. Incidence and risk factors for pressure injuries in patients who have undergone vascular operations: a scoping review. Eur J Med Res. 2023 Feb 13;28(1):77. doi: 10.1186/s40001-023-01036-3.
- Results publication: PubMed 25874704Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012 Sep;24(9):234-41.
- Individual participant dataSharing planned: No
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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.
Mei-Chu Tsai, MN study director
Nursing Department of Taoyuan Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing full bed silicone mattress plus other measures in people with Pressure Injury and Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of surgery-related pressure injuries (time frame: baseline, pre-surgery; every two hours during the surgery till ten hours; and post-surgery to the 2nd day after surgeryl). 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 NCT06316726, which also lists 9 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 18 Mar 2024.