NCT05445960 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cushing H
Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.
Hung M, Baumhauer JF, Licari FW, Voss MW, Bounsanga J, Saltzman CL
PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics. Foot Ankle Int. 2019 Jan;40(1):65-73. doi: 10.1177/1071100718800304. Epub 2018 Oct 4.
Konrad G, Markmiller M, Lenich A, Mayr E, Rüter A
Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94.
Omeroglu H, Günel U, Biçimoglu A, Tabak AY, Uçaner A, Güney O
The relationship between the use of tourniquet and the intensity of postoperative pain in surgically treated malleolar fractures. Foot Ankle Int. 1997 Dec;18(12):798-802.
Wilgis EF
Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6.
Younger AS, Kalla TP, McEwen JA, Inkpen K
Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17.

Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery

Clinical trial NCT05445960 - References