Clinical trial NCT05329493: A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
Official title: A Novel Cooling Device for Pain Management During Fingerstick Blood Draw
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood
Keywords: Blood Draw
Fingerstick Blood Draw
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators seek to evaluate a novel tissue-cooling device for pain management during needle sticks and /or blood draw on the fingertips.

Detailed description: Patient compliance with laboratory testing is one of the most underrecognized challenges in developing a treatment plan for acute and chronically ill patients. The ability to offer alternatives to standard venipuncture blood draws would greatly increase a laboratory's ability to provide testing to patients and health care providers.The fingerstick blood draw has been used as an alternative.

Aiming a less painful, potentially easier alternative we devised a novel that can be applied distally on the digit prior to the blood collection procedure and may provide analgesia through a liquid coolant that is run through tubes in the device to safely cool tissue to achieve numbing. We hypothesize that this device will safely and effectively reduce the pain associated with the fingertip pricks and increase the amount of capillary blood collected.

Multiple punctures with a large lancet were a frequent cause of discomfort among patients.With this new device the discomfort will be reduced by its application followed by the numbness of the finger.

The investigators plan to have 12 patients to complete the study. Subjects must be equal to greater than 18 years old and younger than 60 years older and may be any gender or Fitzpatrick skin type.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent to participate in the study.

  * Male or Female subjects, ≥ 18 and ≤ 60 years of age at the time of enrollment.
  * All Fitzpatrick Skin Types are eligible
  * General good health confirmed by medical history and skin examination of the area to be treated
  * Subjects fifth finger is 17-23mm in diameter at the distal phalanges.

Exclusion Criteria:

* • Subject has had a surgical procedure(s) in the intended area of treatment in the last 6 months.

  * Sensitivity to the cold or history of cold-induced diseases including Raynaud's disease and cryoglobulinemia
  * Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  * Suffering from significant skin conditions in treatment areas or inflammatory skin condition, including but not limited to open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Principal Investigator's discretion) or during the treatment course.
  * History of keloid scarring, abnormal wound healing and /or prone to bruising.
  * History of epidermal or dermal disorders (Particularly if involving collagen or micro vascularity) including collagen vascular disease or vasculitis disorders
  * Subject is unable or unwilling to comply with the study requirements.
  * Subject is currently enrolled or has been enrolled within the prior 3 months in a clinical study of any other unapproved investigational drug or device.
  * Any other condition that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: day 1
Secondary outcomes:
measure: Blood Absorption Via Whatman 903 Filter Paper (Surface Area)
timeFrame: Day 1
measure: Blood Absorption Via Whatman 903 Filter Paper (Drops of Blood)
timeFrame: Day 1
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Clinical Unit for Research Trials & Outcomes in Skin
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dieter Manstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jankowski CA, Casapao AM, Siller S, Isache C, Cani KV, Claudio AM, Brown M, Milstid B, Feldhammer M. Preanalytical Challenges During Capillary Fingerstick Sampling Preclude Its Widespread Use in Adult Hospitalized Patients. Am J Clin Pathol. 2021 Feb 11;155(3):412-417. doi: 10.1093/ajcp/aqaa138.
citation: Kertes DA, Kamin HS, Liu J, Bhatt SS, Kelly M. Putting a finger on the problem: Finger stick blood draw and immunization at the well-child exam elicit a cortisol response to stress among one-year-old children. Psychoneuroendocrinology. 2018 Jul;93:103-106. doi: 10.1016/j.psyneuen.2018.04.021. Epub 2018 Apr 22.
citation: Iwasawa H, Nishimura T, Nemoto S, Aikawa N, Watanabe K. Correlation of the Blood Test Results Obtained between Assays Using Microliter-scale Fingertip Blood Samples Collected with a Novel Blood Collection Device and Conventional Venous Blood Assays: a Secondary Publication in English. Keio J Med. 2018 Jun 25;67(2):26-34. doi: 10.2302/kjm.2017-0009-OA. Epub 2017 Nov 21.
citation: Sugimoto S, Tateishi A, Osawa S. [Development of the fingertip blood dilution method for blood cell counting]. Rinsho Byori. 2014 Mar;62(3):235-40. Japanese.