Pressure UlcerNCT03557489
Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position
A study testing Mepilex Border Sacrum in people with Pressure Ulcer, run by Taipei Medical University Shuang Ho Hospital.
Trial summary
In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Mepilex Border Sacrum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2018to 28 Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.
Who cannot join
- under 20 years
- Patients have any skin lesion.
Trial locations and contacts
No sites are listed yet.
About this study
In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility.
The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.
Read the detailed description
The incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. Based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. Sacral foam pad (Mepilex(®) Border Sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. In this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. The patients will randomized to control and intervention groups, both groups recruited 105 patients. In control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (Mepilex(®) Border Sacrum) in intervention group. After surgery, the occurrence and severity of sacral pressure injury was evaluated. The results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.
- Conditions
- Pressure Ulcer
- Being tested
- Mepilex Border Sacrum
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border SacrumDevice
Patients use gel pad(in usual) in addition to use Mepilex Border Sacrum foam pad during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients use gel pad(in usual) in addition to(Mepilex Border Sacrum)foam pad during surgery. Receives: Device: Mepilex Border Sacrum |
| Control group | No intervention | patients use gel pad(in usual) during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacral pressure injury
After surgery check patient's sacral skin condition
Measured: After 1 hour surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start16 Jun 2018 (estimated)
- Primary completion15 Dec 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAH CHUN, Taipei Medical University Shuang Ho Hospital
- Investigators
- Chun Mah, MS, Principal investigator, Deputy Director of Nursing Department in Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557489
- Sponsor's protocol ID
- 107HCP-08
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sacral Foam Pad in Preventing Pressure Injury in Surgical Patients With Supine Position
- ClinicalTrials.gov ID
- NCT03557489
- Acronym / sponsor ID
- 107HCP-08
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 16 Jun 2018 (estimated)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 15 Jun 2018 (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.
In surgical patients, prevention of pressure injury is a challenge because of the high risk for multiple comorbid conditions, hemodynamic instability, and long duration of immobility.
The objectives of our study is to compare the difference in incidence rates of sacral pressure injury in surgical patients with supine position more than 3 hours between those treated with usual preventive care and a sacral foam pad versus a control group receiving usual care.
Detailed description
The incidence of pressure injury in surgical patients about 12% to 45%, though these patients were treated with "gel pad" as routine. Based on the nutritional status of patients, long-term surgery, surgical posture, and anesthesia-induced hypotension, pressure injury still occurred. Sacral foam pad (Mepilex(®) Border Sacrum) is an unique 5-layer design, was designed to protect sacral pressure injury. In this study, we enrolled surgical patients who need to supine over ≧ 3 hours to evalute the effectiveness of sacral foam pad in preventing sacral pressure injury. The patients will randomized to control and intervention groups, both groups recruited 105 patients. In control group, patients use gel pad during surgery; whereas patients use gel pad in addition to sacrum foam pad (Mepilex(®) Border Sacrum) in intervention group. After surgery, the occurrence and severity of sacral pressure injury was evaluated. The results of this study can provide evidence to improve the awareness of operating room medical staff on surgical pressure injury, and find out the risk factors in avoiding of pressure injury, and offer an effective strategy to enhance the quality of surgery throughout the perioperative care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Mepilex Border SacrumPatients use gel pad(in usual) in addition to(Mepilex Border Sacrum)foam pad during surgery. |
| Control group | No intervention | –patients use gel pad(in usual) during surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.20-99 years old surgical patients who need to supine position over ≧ 3 hours 2.Patients have no any skin lesion.
Key exclusion criteria (2 listed)
- under 20 years
- Patients have any skin lesion.
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 |
|---|---|---|
| Mepilex Border SacrumPatients use gel pad(in usual) in addition to use Mepilex Border Sacrum foam pad during surgery. | Device | Experimental group |
Primary outcome
Sacral pressure injury
Time frame: After 1 hour surgery
After surgery check patient's sacral skin condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
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.
Chun Mah, MS principal investigator
Deputy Director of Nursing Department in Shuang Ho Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Border Sacrum in people with Pressure Ulcer, run by Taipei Medical University Shuang Ho Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Chun Mah, MS (886-2-22490088 ext. 8601, machun786@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sacral pressure injury (time frame: After 1 hour surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2018.