Use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

Hospital do Coracao

Status: Invitation-only

Conditions: Foot Fracture; Ankle Fractures; Foot Injuries and Disorders; Ankle Injuries

Treatments: Device: Pneumatic Tourniquet; Device: HemaClear

Study type: Interventional

Funder types: Other

Identifiers

NCT04818775

HemaClear

Details and patient eligibility

About

This is a Randomized controlled trial evaluating the effects of the use of Sterile HemaClear Tourniquet Below Calf Versus Pneumatic Tourniquet at the Thigh for Ankle and Foot Surgery

The trial will randomize 60 patients into an experimental group with HemaClear or Active comparator group with Pneumatic Tourniquet.

The outcomes are: effectiveness of the tourniquet, bleeding escapes, infection, deep vein thrombosis, pain at the tourniquet site, neurologic problems related to the tourniquet

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ankle and foot surgery

Exclusion criteria

• Infection
• Tumors
• Open fracture
• Burns
• Varicose veins
• Isquemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

HemaClear

Experimental group

Treatment:

Device: HemaClear

Pneumatic Tourniquet

Active Comparator group

Treatment:

Device: Pneumatic Tourniquet