Tendon adhesion and finger range-of-motion limitation after flexor tendon repair in Zone II..
Conditions
Interventions
Intervention 1: Intervention group: Translation:In this group, after primary repair of the flexor tendon in Zone II and before skin closure, 2 mL of topical tranexamic acid with a concentration of 100
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients who sustained a complete transection of the flexor digitorum profundus tendon in Zone II following a sharp laceration of the volar surface of the finger.
Exclusion criteria
Exclusion criteria: Concomitant injury to vital structures in the affected finger, including the digital nerve or artery. Presence of an associated fracture or bony injury in the same finger or the palm. Any level of joint involvement in the affected finger that may interfere with accurate evaluation of tendon repair. History of systemic disorders affecting blood coagulation (such as hemophilia, thrombophilia), disseminated intravascular coagulation (DIC), or use of oral or injectable anticoagulant medications (e.g., warfarin, heparin, or NOACs). Known hypersensitivity or previous allergic reaction to tranexamic acid or related medications. Presence of significant comorbid conditions that may affect tendon healing or the rehabilitation process (such as uncontrolled diabetes mellitus, connective tissue disorders, or advanced renal failure). History of previous surgery on the same finger or the presence of extensive scar tissue that may confound outcome evaluation. Lack of cooperation from the patient or parents in follow-up visits, rehabilitation, or attendance for clinical evaluations. Occurrence of acute unrelated complications during the study period (such as systemic infection or a new injury to the same hand) that could influence the results. A non-sharp mechanism of injury resulting in tendon crushing rather than a clean laceration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically significant tendon adhesion requiring tenolysis following Zone II flexor tendon repair during the follow-up period. Timepoint: At the fourth postoperative week and at six months after surgery. Method of measurement: Clinical assessment by a hand surgery specialist and confirmation of the need for surgical tenolysis based on functional limitation and lack of improvement in finger range of motion during follow-up examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of local postoperative complications including infection, tissue necrosis, and impaired wound healing. Timepoint: At the fourth postoperative week and at six months after surgery. Method of measurement: Clinical examination by a hand surgery specialist and documentation of infection, tissue necrosis, or impaired wound healing during follow-up visits.;Length of postoperative hospital stay. Timepoint: At six months after surgery. Method of measurement: Review of hospital medical records and documentation of the number of postoperative hospitalization days.;Incidence of systemic postoperative complications including thrombosis and embolism. Timepoint: Four weeks after surgery. Method of measurement: Clinical evaluation and, when indicated, diagnostic imaging such as Doppler ultrasonography or computed tomography, with documentation of thrombosis or embolism by the responsible specialist.;Disability and symptom score of the upper limb based on the Disabilities of the Arm, Shoulder and Hand questionnaire at six months after surgery. Timepoint: Six months after surgery. Method of measurement: The standardized Disabilities of the Arm, Shoulder and Hand questionnaire completed by the patient six months after surgery. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza alizade
Shahid Beheshti University of Medical Sciences
Outcome results
None listed