Acute Coronary SyndromeRACCNCT04900987
Steri-strips for Reducing Radial Artery Compression Duration
A study testing Steri-strips in people with Acute Coronary Syndrome, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Steri-strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiography through transradial approach
- Either gender with age ≥18 years
- Positive Barbeau test (type A to C)
Who cannot join
- Patients refuse to give consent
- Negative Barbeau test (type D)
- Patients with bleeding diathesis or on oral anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band: An Open-label Randomized Controlled Trial
The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Consequently, the frequency of radial artery occlusion (RAO) will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration.
Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch. Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis. The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method. In a study conducted by Faravash et al. in 2016, showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid, malar and cheek soft tissues with use of steri-strips with no reported safety concerns.
Therefore, the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression.
Read the detailed description
Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.
Treatment group. Pneumatic TR band compression with use of steri-strips
Control group. Pneumatic TR band compression alone
Method of radial artery compression after sheath removal:
Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.
Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.
END POINTS:
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
- Conditions
- Acute Coronary Syndrome
- Being tested
- Steri-strips
- Keywords
- Radial artery, TR Band, Steri-strips, Coronary angiogram, Radial patency
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steri-stripsDevice
Pneumatic TR band compression with use of steri-strips
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour. Receives: Device: Steri-strips |
| Control group | No intervention | Application of pneumatic TR band alone for 4 hours as per usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of
Time duration of achieving hemostasis
Measured: Immediately after removal of TR band
Number of Participants with
Radial artery patency
Measured: After 24 hour of removal of TR band
Secondary outcomes (2)
Number of Participants with
Hematoma
Measured: Immediately after removal of TR band
Number of Participants with
Bleeding
Measured: Immediately after removal of TR band
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Acute Coronary SyndromeStudies 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
- Model description
- patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamran Ahmed Khan, National Institute of Cardiovascular Diseases, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900987
- Sponsor's protocol ID
- ERC-29/2021
- Acronym
- RACC
- Status last verified
- Feb 2022
- First submitted
- 20 May 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Farahvash MR, Khorasani G, Mahdiani Y, Taheri AR. The Effect of Steri-Strip Dressing on Patients' Satisfaction and Reduction of Ecchymosis in Lower Eyelid, Malar and Cheek Following Rhinoplasty. World J Plast Surg. 2016 Jan;5(1):51-7.
PubMed 27308241
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band: An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04900987
- Acronym / sponsor ID
- RACC / ERC-29/2021
- Conditions
- Acute Coronary Syndrome
- Keywords
- Radial artery, TR Band, Steri-strips, Coronary angiogram, Radial patency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 May 2021 (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 duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Consequently, the frequency of radial artery occlusion (RAO) will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration.
Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch. Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis. The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method. In a study conducted by Faravash et al. in 2016, showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid, malar and cheek soft tissues with use of steri-strips with no reported safety concerns.
Therefore, the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression.
Detailed description
Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.
Treatment group. Pneumatic TR band compression with use of steri-strips
Control group. Pneumatic TR band compression alone
Method of radial artery compression after sheath removal:
Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.
Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.
END POINTS:
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Steri-stripsAfter putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour. |
| Control group | No intervention | –Application of pneumatic TR band alone for 4 hours as per usual practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing coronary angiography through transradial approach
- Either gender with age ≥18 years
- Positive Barbeau test (type A to C)
Key exclusion criteria (3 listed)
- Patients refuse to give consent
- Negative Barbeau test (type D)
- Patients with bleeding diathesis or on oral anticoagulation
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 |
|---|---|---|
| Steri-stripsPneumatic TR band compression with use of steri-strips | Device | Treatment group |
Primary outcome
Mean of
Time frame: Immediately after removal of TR band
Time duration of achieving hemostasis
Number of Participants with
Time frame: After 24 hour of removal of TR band
Radial artery patency
2 secondary outcomes
Number of Participants with
Time frame: Immediately after removal of TR band
Number of Participants with
Time frame: Immediately after removal of TR band
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 16 Feb 2022.
- Results publication: PubMed 27308241Farahvash MR, Khorasani G, Mahdiani Y, Taheri AR. The Effect of Steri-Strip Dressing on Patients' Satisfaction and Reduction of Ecchymosis in Lower Eyelid, Malar and Cheek Following Rhinoplasty. World J Plast Surg. 2016 Jan;5(1):51-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steri-strips in people with Acute Coronary Syndrome, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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 3 inclusion and 3 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 16 Feb 2022. 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 Pakistan. 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?
Mean of (time frame: Immediately after removal of TR band). The study lists 2 primary outcomes in all. 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 NCT04900987, 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 16 Feb 2022.