Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201409000879274 Date of Approval: 31/08/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fibrin glue in peripheral nerve repair
Official scientific title The Effects of Autologous Fibrin Glue versus Microsuture on the Surgical Reconstruction of Peripheral Nerves: A Randomized Prospective Clinical Trial
Brief summary describing the background and objectives of the trial The nonabsorbable microsuturing is the gold standard for accurate approximation of nerve ends in peripheral nerve repairs. However, the main issue of the traditional microsuturing is being capable of eliciting a foreign body reaction, impairing vascularity, and potentially disrupting axonal regeneration. Consequently, different studies have suggested that sutureless methods, including fibrin glue, might offer a better alternative option to traditional microsuture techniques without impeding nerve regeneration or functional recovery. Fibrin glue is a two-component system (concentrated fibrinogen obtained by cryoprecepitation and thrombin) derived from whole blood which, when mixed, reproduces the final pathway of blood coagulation to form a viscous adhesive that is reported to maintain tissue (nerve) approximation. Fibrin glue is encouragingly used to decrease operative times and help maintain proper nerve orientation to potentially optimize recovery. The purpose of the study is to evaluate the efficacy of fibrin glue application versus the conventional microsuturing technique regarding operative time and functional patients¿ outcome in various reconstructive peripheral nerves surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Peripheral nerve injuries,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/09/2014
Actual trial start date
Anticipated date of last follow up 31/08/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Each participant will be randomly assigned following simple randomization procedure by using closed white envelops: 30 envelops assign the group to be followed. Those envelops include 15 paper charts (Fig. A) and 15 paper charts (Fig. B), which are folded three times not to show its contents to assure random assignment. WITH Conventional microsuturing Figure A: Paper inside the closed white envelopes WITH Fibrin glue Figure B: Paper inside the closed white envelopes. Sealed opaque envelops Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Peripheral nerve repair by fibrin glue once: Five mL Fibrinogen and factor XIII containing precipitate will be drawn into a syringe. A second syringe will contain five mL autologous thrombin and 1.5 mL of Calcium Gluconate solution. The two components will be mixed and allowed to stand at room temperature for 10 min. then will seal the surgical incision line and both nerve ends. It will be left undisturbed for 5 min. in situ. After surgical exposure, external neurolysis will be performed and both ends of the nerve will be trimmed until the neuroma and fibrous tissues are excised and healthy group fascicles are seen. Approximation of the nerve ends is carried out by fibrin glue. 15
Control Group Peripheral nerve repair by standard microsuturing technique once Following surgical exposure, external neurolysis will be performed and both ends of the nerve will be trimmed until the neuroma and fibrous tissues are excised and healthy group fascicles are seen. Approximation of the nerve ends is carried out by standard microsutures. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Male and female patients. - Ages >20 years. - Patients with complete radial, ulnar or median nerves injuries at arm, forearm or wrist level as well as with complete sciatic or common peroneal injuries. - Time between injury and surgery is not more than 6 months. - No medical contraindications to surgery. - Patients younger than 18 years - patients with partial nerve injuries. - Patients suffering brachial or lumbosacral plexus palsies. - Injuries that are expected to recover spontaneously (neuropraxia and axontemesis). - Established chronic illnesses that can affect joints motion, nerve healing or patients¿ compliance (like neuropathies, dementia, and mental retardation). 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/08/2014 High Research Ethics Committee, Faculty of Medicine, Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Kilo 4.5, Ring road Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Motor and sensory recovery - 6 weeks after surgery - 12 weeks after surgery - 6 months after surgery - 12 months after surgery
Secondary Outcome Operative time Intra-operative assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals, Hand and microsurgery unit, Orthopedic surgery department 4.5 Km Ring road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Governmental health insurance Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41112 Egypt
Suez Canal University Hospitals, Clinical pathology department 4.5 Km Ring road Ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asser Sallam, MD, PhD 4.5 Km Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Salah, MD 4.5 Km Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41111 Egypt
Noha Kamel, MD 4.5 Km Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, 5th Stage, El-Sheikh Zayed District
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Public Enquiries Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, 5th Stage, El-Sheikh Zayed District
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Scientific Enquiries Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, 5th Stage, El-Sheikh Zayed District
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information