PhlebitisNCT06216522
The Effectiveness of Topical Sesame Oil in Preventing Phlebitis at IV Cannula Sites in Adults
A study testing Topical Sesame Oil and Liquid paraffin oil in people with Phlebitis and Thrombophlebitis, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Phlebitis, Thrombophlebitis
- What is being tested?
- Topical Sesame Oil and Liquid paraffin oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Apr 2022to 21 Oct 2022
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-80
- Patients must speak and understand either English or Mandarin
- Patients who possess a peripheral IV cannula
- IV cannula must have been inserted for less than 12 hours
- IV cannula must be on an upper extremity
- IV cannula must be patent
- IV cannula sites must show no signs of redness, swelling, pain, a palpable venous cord or pyrexia
- Patient must be admitted to a cardiology ward in the National Heart Centre Singapore
Who cannot join
- Patients who do not speak or understand either English or Mandarin
- Patients with venous insufficiency
- Patients with coagulopathies
- Patients with cognitive or sensory impairments that would inhibit their ability to rate their pain via a Numerical Rating Scale (NRS)
- Patients who are receiving medications that might interfere with timely reporting of adverse events (eg. medications that cause severe drowsiness)
- Patients who report allergies to sesame or liquid paraffin oil
Show all 9Show fewer
- IV cannulas that were inserted and used for resuscitation
- Patients with existing skin conditions that cause their skin to be red or swollen and might affect the investigators ability to assess for phlebitis
- Patients who possess more than one peripheral IV cannula will only be included in the study once. All subsequent IV cannula insertions will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised-controlled Trial on the Effectiveness of Topical Sesame Oil in Preventing Phlebitis at Intravenous Cannula Sites in Adult Patients
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
The main question it aims to answer is:
Read more
Is topical sesame oil effective in preventing phlebitis at peripheral IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital?
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12 hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side.
Researchers will compare the phlebitis incidence and severity of each group to see if topical sesame oil is more effective than liquid paraffin oil in preventing phlebitis at IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
Read the detailed description
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
All newly admitted patients with an existing IV cannula will be approached after being admitted into an inpatient ward. This will take place within 12 hours of the IV cannula insertion. They will not be approached if in distress, drowsy or immediately prior to a surgical procedure. The IV cannula will be tested for patency, and assessed for redness, swelling, pain, a palpable venous cord or pyrexia. If any of these symptoms are present, or if the IV cannula is not patent, the recruitment will be terminated.
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12 hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side.
Demographic and clinical data will be recorded into a table. The patient will be instructed not to wash or wipe the topical agent off. The time and date of the start of treatment applied and subsequent treatments at 12 hour intervals will be documented. At the start of the study and at each 12 hour interval, the investigator will observe for signs of phlebitis using the modified Visual Infusion Phlebitis (VIP) scoring tool (1), before application of the next treatment. The study investigators will be the only ones applying the treatment/control and completing the data collection form every 12 hours.
Application of the treatment or control will be made every 12 hours for up to 72 hours, where the IV cannula will then be removed according to hospital guidelines. The IV cannula site will be observed, every 12 hours for up to 24 hours post IV cannula removal, for phlebitis or complications.
Patients will be withdrawn from the study the moment they show signs of adverse reactions from the topical treatment or control.
Participants will be involved in the study for a maximum of 96 hours. If the IV cannula is removed accidentally or not due to phlebitis before the 72-hour period is up, re-insertion of a new cannula and re-application of oils will not be done on a new site.
The application of either sesame oil or liquid paraffin oil is not part of the routine procedures or standard of care in the ward, and will only be applied for the purpose of this research. Both the sesame oil and liquid paraffin oil are marketed products and will be used as per label.
All hardcopy research data will be stored in in a locked cupboard with lock and key access within the National Heart Centre, Singapore. All soft copies will be stored in a password protected Laptop belonging to the principal investigator. Only the principal investigator will have access to the research data. All other members of the research team will access the data through the principal investigator. The physical research data will be kept under lock and key for 7 years after the completion of the research study or date of publication of the research using the research data, whichever is later. After which, all data will be destroyed. Hardcopies will be shredded and soft copies will be deleted.
Subjects may withdraw voluntarily from participation in the study at any time. Subjects may also withdraw voluntarily from receiving the study intervention for any reason. Upon withdrawal, IV cannula sites will continue to be observed for 24 hours at 12-hour intervals for potential reactions to the oils or signs of phlebitis. If there are any adverse reactions to the oils or signs of phlebitis during the 24-hour observation period, the patient will be referred to the attending physician and medical treatment will be rendered. The patient will continue to receive follow-up and medical treatment until symptoms have resolved.
The study may be discontinued at any time, if safety issues arise. If the risks to participants unexpectedly outweigh the benefits due to unexpected severe adverse events due to the application of the treatment or control oils, the study may then be suspended until the risk-benefit ratio is re-evaluated.
- Conditions
- Phlebitis, Thrombophlebitis
- Being tested
- Topical Sesame Oil, Liquid paraffin oil
- Keywords
- intravenous cannula, IV cannula, Adult, Cardiovascular, Cardiothoracic, Phlebitis, Thrombophlebitis
- Medical subject headings
- Phlebitis, Thrombophlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Sesame OilOther
5 drops/0.25mls of sesame oil applied to the IV cannula site at 12 hourly intervals for 72 hours
Liquid paraffin oilOther
5 drops/0.25mls of liquid paraffin oil applied to the IV cannula site at 12 hourly intervals for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 5 drops/0.25mls of 100% sesame oil will be applied to the IV cannula site, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side, every 12 hours for 72 hours. Receives: Other: Topical Sesame Oil |
| Control | Placebo comparator | 5 drops/0.25mls of liquid paraffin oil will be applied to the IV cannula site, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side, every 12 hours for 72 hours. Receives: Other: Liquid paraffin oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phlebitis incidence
Measuring the incidence of phlebitis across both the intervention and control groups
Measured: At 12 hourly intervals for a total of 72 hours
Secondary outcomes (1)
Phlebitis severity
Documenting the severity of phlebitis using the Visual Infusion Phlebitis (VIP) scoring tool, across both the intervention and control groups. It is rated on a scale of zero to five, with five being the worst possible outcome.
Measured: At 12 hourly intervals for a total of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start12 Apr 2022
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhlebitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmine Tan, Principal investigator, Nanyang Polytechnic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216522
- Sponsor's protocol ID
- 2021/2804
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson A. Infection control--a battle in vein: infusion phlebitis. Nurs Times. 1998 Jan 28-Feb 3;94(4):68, 71. No abstract available.
PubMed 9510815
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised-controlled Trial on the Effectiveness of Topical Sesame Oil in Preventing Phlebitis at Intravenous Cannula Sites in Adult Patients
- ClinicalTrials.gov ID
- NCT06216522
- Acronym / sponsor ID
- 2021/2804
- Conditions
- Phlebitis, Thrombophlebitis
- Keywords
- intravenous cannula, IV cannula, Adult, Cardiovascular, Cardiothoracic, Phlebitis, Thrombophlebitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 22 Jan 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.
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
The main question it aims to answer is:
Is topical sesame oil effective in preventing phlebitis at peripheral IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital?
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12 hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side.
Researchers will compare the phlebitis incidence and severity of each group to see if topical sesame oil is more effective than liquid paraffin oil in preventing phlebitis at IV cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
Detailed description
The goal of this randomised controlled trial is to determine the effectiveness of topical sesame oil in preventing phlebitis at peripheral intravenous (IV) cannula sites in adult patients within a cardiovascular and cardiothoracic department of a tertiary hospital.
All newly admitted patients with an existing IV cannula will be approached after being admitted into an inpatient ward. This will take place within 12 hours of the IV cannula insertion. They will not be approached if in distress, drowsy or immediately prior to a surgical procedure. The IV cannula will be tested for patency, and assessed for redness, swelling, pain, a palpable venous cord or pyrexia. If any of these symptoms are present, or if the IV cannula is not patent, the recruitment will be terminated.
Participants will be randomly allocated to the experimental or control group with the use of a randomisation software (MS excel). They will each have five drops/0.25mls of 100% sesame oil (experimental) or liquid paraffin oil (control) applied to the IV cannula site, at 12 hourly intervals for a total of 72 hours, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side.
Demographic and clinical data will be recorded into a table. The patient will be instructed not to wash or wipe the topical agent off. The time and date of the start of treatment applied and subsequent treatments at 12 hour intervals will be documented. At the start of the study and at each 12 hour interval, the investigator will observe for signs of phlebitis using the modified Visual Infusion Phlebitis (VIP) scoring tool (1), before application of the next treatment. The study investigators will be the only ones applying the treatment/control and completing the data collection form every 12 hours.
Application of the treatment or control will be made every 12 hours for up to 72 hours, where the IV cannula will then be removed according to hospital guidelines. The IV cannula site will be observed, every 12 hours for up to 24 hours post IV cannula removal, for phlebitis or complications.
Patients will be withdrawn from the study the moment they show signs of adverse reactions from the topical treatment or control.
Participants will be involved in the study for a maximum of 96 hours. If the IV cannula is removed accidentally or not due to phlebitis before the 72-hour period is up, re-insertion of a new cannula and re-application of oils will not be done on a new site.
The application of either sesame oil or liquid paraffin oil is not part of the routine procedures or standard of care in the ward, and will only be applied for the purpose of this research. Both the sesame oil and liquid paraffin oil are marketed products and will be used as per label.
All hardcopy research data will be stored in in a locked cupboard with lock and key access within the National Heart Centre, Singapore. All soft copies will be stored in a password protected Laptop belonging to the principal investigator. Only the principal investigator will have access to the research data. All other members of the research team will access the data through the principal investigator. The physical research data will be kept under lock and key for 7 years after the completion of the research study or date of publication of the research using the research data, whichever is later. After which, all data will be destroyed. Hardcopies will be shredded and soft copies will be deleted.
Subjects may withdraw voluntarily from participation in the study at any time. Subjects may also withdraw voluntarily from receiving the study intervention for any reason. Upon withdrawal, IV cannula sites will continue to be observed for 24 hours at 12-hour intervals for potential reactions to the oils or signs of phlebitis. If there are any adverse reactions to the oils or signs of phlebitis during the 24-hour observation period, the patient will be referred to the attending physician and medical treatment will be rendered. The patient will continue to receive follow-up and medical treatment until symptoms have resolved.
The study may be discontinued at any time, if safety issues arise. If the risks to participants unexpectedly outweigh the benefits due to unexpected severe adverse events due to the application of the treatment or control oils, the study may then be suspended until the risk-benefit ratio is re-evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Topical Sesame Oil5 drops/0.25mls of 100% sesame oil will be applied to the IV cannula site, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side, every 12 hours for 72 hours. |
| Control | Placebo comparator | Other: Liquid paraffin oil5 drops/0.25mls of liquid paraffin oil will be applied to the IV cannula site, from 3cm above the insertion point to 10cm along the vein, with a width of 2cm on either side, every 12 hours for 72 hours. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21-80
- Patients must speak and understand either English or Mandarin
- Patients who possess a peripheral IV cannula
- IV cannula must have been inserted for less than 12 hours
- IV cannula must be on an upper extremity
Key exclusion criteria (9 listed)
- Patients who do not speak or understand either English or Mandarin
- Patients with venous insufficiency
- Patients with coagulopathies
- Patients with cognitive or sensory impairments that would inhibit their ability to rate their pain via a Numerical Rating Scale (NRS)
- Patients who are receiving medications that might interfere with timely reporting of adverse events (eg. medications that cause severe drowsiness)
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 |
|---|---|---|
| Topical Sesame Oil5 drops/0.25mls of sesame oil applied to the IV cannula site at 12 hourly intervals for 72 hours | Other | Intervention |
| Liquid paraffin oil5 drops/0.25mls of liquid paraffin oil applied to the IV cannula site at 12 hourly intervals for 72 hours | Other | Control |
Primary outcome
Phlebitis incidence
Time frame: At 12 hourly intervals for a total of 72 hours
Measuring the incidence of phlebitis across both the intervention and control groups
1 secondary outcome
Phlebitis severity
Time frame: At 12 hourly intervals for a total of 72 hours
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 21 Feb 2024.
- Background: PubMed 9510815Jackson A. Infection control--a battle in vein: infusion phlebitis. Nurs Times. 1998 Jan 28-Feb 3;94(4):68, 71. No abstract available.
- 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.
Jasmine Tan principal investigator
Nanyang Polytechnic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Sesame Oil and Liquid paraffin oil in people with Phlebitis and Thrombophlebitis, run by National Heart Centre Singapore at 1 site in Singapore.
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 8 inclusion and 9 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 21 Feb 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Phlebitis incidence (time frame: At 12 hourly intervals for a total of 72 hours). 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 NCT06216522, which also lists 1 linked publication.
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 21 Feb 2024.