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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008851772042 Date of Registration: 31/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Novel hemostatic dressing
Official scientific title Novel nanotechnology-based hemostatic dressing; A proof-of-concept clinical trial
Brief summary describing the background and objectives of the trial Bleeding is a major cause of post-traumatic deaths and post-intervention morbidity and mortality. Improvement of hemostatic dressings is still needed to efficiently control bleeding of different severity. A novel hemostatic device has been recently developed. It comprises medical gauze impregnated with specific hemostatic agents developed by nanotechnology. This device has been already proven its efficacy and safety in a previous survival animal experiment. The present trial represents proof-of-concept phase 0 clinical trial to preliminary explore the efficacy and safety of the novel device in humans. It will be tested to control bleeding during operative procedures and compared against the normal gauze. All the types of hemostatic devices usually used during operations, as normal gauze, electric cautery, ligatures, and suturing will be available.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) NaHeD
Disease(s) or condition(s) being studied Haematological Disorders,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2020
Actual trial start date
Anticipated date of last follow up 01/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Novel hemostatic device used to control bleeding during surgical operations. The sterilized device, in the form of medical gauze impregnated in the specific hemostatic agent, will be applied directly to the bleeding surface aiming at control of bleeding. The single application cycle will be 3 minutes. It can be repeated according to the surgeon's decision. The newly tested hemostatic device will be used as an optional measure to control intra-operative bleeding during surgery, either external or internal. For the sake of patient's safety, all the hemostatic devices usually used during surgery will be available through out the trial. The bleeding severity is classified into: 1. Mild: it is possible to stop the bleeding by normal-gauze compression. 2. Moderate: it is possible to stop the bleeding by electric cautery, but not with normal gauze compression. 3. Severe: it is only possible to stop the bleeding by suturing and/or ligation. 4. Torrential: it is life-threatening with extensive bleeding that needs sophisticated measures to control as vessel clamping, blood transfusion etc. The test device is used as an option for hemostasis in the cases of either severe bleeding. Cases with mild, moderate or torrential bleeding will be excluded from the study. The gauze was applied as a four-fold layer directly on the bleeding surface. The size of the dressing should cover the whole bleeding area. The hemostatic efficacy of the device is graded into: • Poor: Bleeding persisted and another hemostatic method was needed to control it. • Fair: Bleeding decreased but another hemostatic method was still needed. • Good: Minor bleeding persisted but there was no need for further hemostasis. • Excellent: Bleeding stopped completely. In the case of poor or fair efficacy with the tested gauze, another method was used as needed. Prospectively collected data include: demographic data, type of operation, type of bleeding surface, severity of bleeding, number of application cycles, total time of application, grade of hemostatic efficacy, and any application-related complications whether intraoperative or postoperative (could be related to hemostasis, to local application, or systemic effect). All patients were followed up for at least one week after operation. 30
Control Group normal surgical gauze or electric cautery to control bleeding during operation compression application of the normal gauze on the bleeding surface for 4 minutes single application for 3 minutes The normal surgical gauze will be applied by compression to the bleeding surface during operation for 4 minutes, If the bleeding stopped, it will be classified as mild bleeding and the case will be excluded from the study. If the bleeding continued and is classified as moderate or severe, the case will be included in the study and the test device will applied to the bleeding surface as described before. Torrential bleeding will be excluded from the study from the start. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients undergoing different surgery that may lead to bleeding during the steps of the operation. patients with bleeding severity either moderate or severe according to the mentioned severity score. Patients with bleeding disorders. Patients with intra-operative disorders that dictate quick completion of the procedure, as severe hypotension, hypo-oxygenation etc. patients with bleeding severity either mild or torrential according to the mentioned severity score. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 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 15/07/2020 The Committee of Medical Ethics of the Faculty of Medicine in Assiut University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Assiut University Campus Assiut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The grade of hemostatic efficacy of the test device application in comparison to normal gauze compression At the end of the test for each patient
Secondary Outcome The related complications of the test device application, whether intra-operative or post-operative. during the operation and at the end of the follow up period after the operation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nile Hospital Maamoun Street 11 Assiut 71151 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
EgyNano Pharma company Galaa Street 26 Assiut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Mostafa Hamad Faculty of Medicine, Assiut University Campus Assiut 71151 Egypt Individual
Secondary Sponsor EgyNano Pharma Company Galaa Street 26 Assiut 71151 Egypt Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof. Mahmoud Elsabahy Department of Pharmaceuticals, Faculty of Pharmacy, Assiut University Campus Assiut 71151 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Hamad mostafa_hamad@yahoo.com +201222438186 Department of Surgery, Faculty of Medicine, Asssiut University Campus
City Postal code Country Position/Affiliation
Assiut 71151 Egypt Assiut University
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elsabahy mahmoud.elsabahy@gmail.com +201000607466 Department of Pharmaceuticals, Faculty of Pharmacy, Assiut University Campus
City Postal code Country Position/Affiliation
Assiut 71151 Egypt Assiut University
Role Name Email Phone Street address
Public Enquiries Tahra Sherif tahrasherif@yahoo.com +201227446166 Department of Clinical Pathology, Faculty of Medicine, Assiut University Campus
City Postal code Country Position/Affiliation
Assiut 71151 Egypt Assiut University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data will be available after deidentification. Informed Consent Form,Study Protocol immediately after publication and for 5 years The data will be available for researchers who provide a methodologically sound proposal to achieve aims in that approved proposal. Proposal should be directed to mostafa_hamad@yahoo.com.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information