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IRCT20180627040252N3 IRCT 2022-06-17 Yazd University of Medical Sciences Surgiwrap in tendon repair Comparison of Extensor tendon repair methods with surgiwrap and without surgiwrap, as regards the rate of adhesion in patients with hand extensor tendon injury 2019-09-03 anticipated 40 Complete https://irct.ir/trial/56652 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients entered the study after obtaining informed consent until reaching the final specified sample size (80 tendon samples). The sample size was 40 patients for 95% confidence level and 80% test power and 9.1 standard deviations for the main outcome of the motion difference. Because most patients had rupture of several extensor tendons; 80 specimens of extensor tendons were considered except for the thumb extensors. Each patient participating in the study was assigned to two intervention groups using block randomisation until the extensor tendon sample size was completed in a ratio of 1: 1, Blinding description: In this study, all participants are aware of participating in this study and enter the study with their consent. participants are unaware of which group of this study they are in. The lead researcher, health care personnel, data collection officials, and those who evaluate the outcome are aware of the grouping of patients. Those who prepare the draft of the article are unaware of the groupings if they do not cooperate in the above cases. N/A Laceration of extensor muscle, fascia or tendon of other finger at wrist or hand level. Intervention 1: Control group: Patients were referred to the operating room of the hospital for surgery and after randomly assigning them to the two intervention groups by operating room admission, in both groups (control and intervention) the standard treatment method (SOC) is as follows: Patients undergo local anaesthesia (5% lidocaine) and initial repair, and an arm tourniquet is used. Wounds are examined and washed with normal saline and the tendons cut are repaired by a surgeon with Prolen 3.0 and end-to-end running (SOC) method. The skin is then wrapped in nylon 5.0. All patients' hands are immobilized for 3 to 6 weeks (4 weeks) by static splint in the position of 40-45 degrees of extension in the wrist, 20 degrees of flexion in the metacarpophalangeal joint, and zero degrees of flexion of the interphalangeal joints to protect the repair site. From there, the protected active movement begins. Intervention 2: Intervention group: Patients were referred to the operating room of the hospital for surgery and after randomly assigning them to the two intervention groups by operating room admission, in both groups (control and intervention) the standard treatment method (SOC) is as follows: Patients undergo local anaesthesia (5% lidocaine) and initial repair, and an arm tourniquet is used. Wounds are examined and washed with normal saline and the tendons cut are repaired by a surgeon with Prolen 3.0 and end-to-end running (SOC) method. In the intervention group (SOC + S) after tendon repair, (Barrier (Surgiwrap) is placed between the skin and tendon and is sewn on 4 sides of the tendon with 05 sutures. so that, each side cover one centimetre more than the repair site. The skin is then wrapped in nylon 5.0. All patients' hands are immobilized for 3 to 6 weeks (4 weeks) by static splint in the position of 40-45 degrees of extension in the wrist, 20 degrees of flexion in the metacarpophalangeal joint, and zero degrees of flexion of the interphalangeal joints to protect the repair site. From there, the protected active movement begins. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Researchers have not yet decided on information sharing.
public Morteza Rezaei
Office of the Surgery Group, Shahid Mohammadi Hospital, Boulevard of the Islamic Republic of Iran, Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 912 063 5468 rezaie.mortaza@yahoo.com Bandare-abbas University of Medical Sciences scientific Abbas Abdoli Tafti
Shahid Sadougi hospital, Ebne Sina street, Shahid Ghandi BLvd
Yazd Iran (Islamic Republic of) 8916886938 +98 35 3822 4000 aabdoli2000@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Zone 6 extensor tendon injury Ability to repair the tendon directly and without shortening Surgical repair indication Completion of informed consent 18 years 65 years Both Patients with uncontrolled diabetes Multiple injuries Simultaneous rupture of flexors with nerves and arteries Inability to direct repair Metacarpal fracture Crush injury NC57.31 Laceration of extensor muscle, fascia or tendon of other finger at wrist or hand level Treatment - Surgery Treatment - Surgery Control group: Patients were referred to the operating room of the hospital for surgery and after randomly assigning them to the two intervention groups by operating room admission, in both groups (control and intervention) the standard treatment method (SOC) is as follows: Patients undergo local anaesthesia (5% lidocaine) and initial repair, and an arm tourniquet is used. Wounds are examined and washed with normal saline and the tendons cut are repaired by a surgeon with Prolen 3.0 and end-to-end running (SOC) method. The skin is then wrapped in nylon 5.0. All patients' hands are immobilized for 3 to 6 weeks (4 weeks) by static splint in the position of 40-45 degrees of extension in the wrist, 20 degrees of flexion in the metacarpophalangeal joint, and zero degrees of flexion of the interphalangeal joints to protect the repair site. From there, the protected active movement begins. Intervention group: Patients were referred to the operating room of the hospital for surgery and after randomly assigning them to the two intervention groups by operating room admission, in both groups (control and intervention) the standard treatment method (SOC) is as follows: Patients undergo local anaesthesia (5% lidocaine) and initial repair, and an arm tourniquet is used. Wounds are examined and washed with normal saline and the tendons cut are repaired by a surgeon with Prolen 3.0 and end-to-end running (SOC) method. In the intervention group (SOC + S) after tendon repair, (Barrier (Surgiwrap) is placed between the skin and tendon and is sewn on 4 sides of the tendon with 05 sutures. so that, each side cover one centimetre more than the repair site. The skin is then wrapped in nylon 5.0. All patients' hands are immobilized for 3 to 6 weeks (4 weeks) by static splint in the position of 40-45 degrees of extension in the wrist, 20 degrees of flexion in the metacarpophalangeal joint, and zero degrees of flexion of the interphalangeal joints to protect the repair site. From there, the protected active movement begins. Tendon adhesion. Timepoint: At the first visit and in the third, sixth and twelfth weeks after splint removal. Method of measurement: Miller’s scoring system. Yazd University of Medical Sciences Approved 2019-09-01 Research Ethics Committees of School of Medicine- Shahid Sadoughi University of Medical Sciences Bahonar Square Yazd Yazd Iran (Islamic Republic of)