An interventional study of "One-per-mil" Tumescent Solution Injection and Saline Solution in Ischemia, sponsored by Indonesia University. Status unknown at 1 site in Indonesia. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-13.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
The aim of this study is to know the characteristic of "one-per-mil" tumescent solution in regards of the optimal time delay to achieve optimal visualization of operation field in hand and digit surgery.
Hypothesis:
This is a prospective, randomized, double-blind study to measure the optimal time delay of 1:1,000,000 epinephrine in saline solution injected by tumescent technique until maximum vasocontriction in the distal finger is achieved.
Subjects will be injected in both his ring fingers(distal phalanges, volar side) with randomized solutions, one containing "one-per-mil" tumescent solution and the other containing only normal saline solution; information which both the injector and examiner are blinded from. Maximum vasoconstriction of the finger injected is depicted by the lowest oxygen saturation (recorded every minute until 45 minutes using pulse oxymeter).
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's planned enrollment of 12 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.
Browse Ischemia studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: "One-per-mil" Tumescent Solution Injection
Procedure: Saline Solution
"One-per-mil" tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger.
Saline solution is injected into the tissue as a placebo control.
Time to achieve lowest oxygen saturation
After being injected with the solution, the ring finger is put on a continuous monitoring of pulse oxymeter, while the examiner records the decrease of oxygen saturation every minute until 45 minutes length of time. The time when lowest oxygen saturation is achieved is recorded, depicting the optimal time delay to achieve maximum vasoconstriction of the finger after injection.
Time frame: 45 minutes
Pain Sensation
Pain sensation of the finger's pulp was examined (using VAS) and recorded every 15 minutes. These data will be compared to the baseline data prior to injection.
Time frame: 45 minutes
Tactile Sensation
Tactile sensation of the finger's pulp was examined (using Semmes Weinstein Touch Test) and recorded every 15 minutes after the injection. We will compare this data with the baseline data collected prior to injection.
Time frame: 45 minutes
Complication
Subjects will be observed for 6 hours after the injection to record any sign and symptoms related to the complication of the procedure (persisted pain, pallor, numbness).
Time frame: 6 hours
Decrease in fingertip's temperature
After injection, temperature of fingertip is measured and recorded every 15 minutes for total time of 45 minutes. The data will be compared with baseline temperature recorded before injection
Time frame: 45 minutes
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Indonesia University