Clinical trial NCT04900987: Steri-strips for Reducing Radial Artery Compression Duration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Radial artery
TR Band
Steri-strips
Coronary angiogram
Radial patency
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary angiography through transradial approach
* Either gender with age ≥18 years
* Positive Barbeau test (type A to C)

Exclusion Criteria:

* Patients refuse to give consent
* Negative Barbeau test (type D)
* Patients with bleeding diathesis or on oral anticoagulation

Primary outcomes:
measure: Mean of
timeFrame: Immediately after removal of TR band
measure: Number of Participants with
timeFrame: After 24 hour of removal of TR band
Secondary outcomes:
measure: Number of Participants with
timeFrame: Immediately after removal of TR band
measure: Number of Participants with
timeFrame: Immediately after removal of TR band
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
References:
citation: 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.