The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair: a Pilot Study
The use of amnionic membrane allograft
Tendon Injuries
+ Wounds and Injuries
Treatment Study
Summary
Study start date: March 1, 2015
Actual date on which the first participant was enrolled.The treatment of flexor tendon transection consists of surgical apposition of the lacerated tendon ends using non-absorbable sutures. Main complications which result in poor outcome of the tendon repair are the rupture of the tendon apposition or substantial adhesion formation between the two tendons or the tendon and the fibro-osseous canal. Adhesion formation is presumed to be a byproduct of the tendon healing. In the course of last 70 decades, the preventive effects of several pharmacological agents and mechanical barriers on adhesion formation have been investigated with some promising findings. One of the mechanical barriers that has been proposed to be suitable for adhesion prevention is human amniotic membrane allograft. However, there are no clinical studies evaluating the use of amniotic membrane in flexor tendon repair. This is a pilot study for the forthcoming randomized controlled study. The objectives of the pilot study are: 1) to test the handleability of the human amniotic membrane allograft in flexor tendon sheath reconstruction in conjunction with flexor tendon repair, 2) to elucidate the possible adverse effects related to the use of amniotic membrane in flexor the sheath, and 3) to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation. The hypothesis of the pilot study is that the application of the human amniotic membrane allograft in tendon sheath reconstruction in flexor tendon injury patients is technically feasible and results in no adverse effects to the patient. A total of 10 patients with an acute flexor tendon injury will be included in the pilot study. After conventional tendoraphia, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath. The primary outcome measure is total range of movement after 6 months of the surgery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location