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IRCT20210707051812N1 IRCT 2022-12-30 Hamedan University of Medical Sciences Comparing Nylon and Vicryl Threads on Wound Healing, Scar and Surgeon Satisfaction A comparative Study of Suturing Inguinal Incision with Vicryl and Nylon Threads on the Wound Healing, Cosmetic Results and Surgeon Satisfaction in Children Undergoing Surgery: A Randomized Clinical Trial Study 2022-12-31 anticipated 56 Complete https://irct.ir/trial/67299 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, Simple Randomization Method and Lottery Type will be used. In this way, a number of folded cards are considered for the Nylon Group and the same number of folded cards are considered for the Vicryl Group. Then the cards are merged and one card is removed and its allocation is recorded. Then the removed card goes back to the cards. Card withdrawal is repeated for the number of samples and a Random Allocation Sequence is obtained. Then each allocation is placed in an Opaque Envelope and the corresponding number is also recorded on the lid of the envelope and arranged in a box according to the sequence. Finally, the first card is taken for the first patient, the second card is taken for the second patient, and so on until the end, Blinding description: Participants and their parents are unaware of which group they are in; However, in order to obtain informed consent, full explanations are provided to them. The generation of random allocation is done by a trusted person outside the research team and the box containing the sequence is provided to the surgeon by the principal investigator. One of the surgeons who is a member of the research team is the only person who knows about the allocation of groups because he performs the suturing. The main researcher has the role of evaluating the outcome and is not aware of the allocation of the groups. In addition, the statistician of the group, who has the role of statistical analysis, does not know about the allocation of groups. In addition, the nurses who take care of the patient in the ward will not be informed about the details of the research groups, and the type of thread cannot be recognized from the wound. N/A Condition 1: Surgical wound healing. Condition 2: Surgical Wound Scar. Intervention 1: Intervention group: skin suture is performed once at the end of surgery with Vicryl thread. The thread used is VICRYL RAPIDE W9940 type and produced by ETHICON company. It is manufactured by ETHICON, LLC, CE 0086, XZW9940.1 AND LOT number of AK7988. The thread size is 3.0 and the thread length is 75 cm. The thread needle is 26 mm and 3/8 circle and reverse cutting type. Intervention 2: Control group: Skin suture is done once at the end of surgery with nylon thread. The thread used is produced by TEB KEYHAN company. It is manufactured by NASG TEB KEYHAN, NO 1467/2, Golchin 2, Golriz 2, West Ghazali blvd, Eshtehard Industrial, Karaj, Iran. The thread size is 3.0 and the thread length is 75 cm. The thread needle is 26 mm and 3/8 circle and reverse cutting type. Yes - There is a plan to make this available What will be shared: After the publication of the article, confidential information such as the names of individuals and organizations will be removed and other information will be provided to the researchers. When: Access starts one month after the article is published To whom: All researchers Conditions: In systematic review studies Where to obtain: Corresponding author: jeyranasadihajivand@gmail.com How to obtain: Official and academic email to the corresponding author and obtaining permission from the Research Vice-Chancellor of Hamadan University of Medical Sciences by the corresponding author Comments:
public Jeyran Asadi Hajivand
No. 17, Behrouz Mohammadi Alley., Baradarane Ghaedi Ave
Tehran Iran (Islamic Republic of) 1149774611 +98 21 7762 1301 jeyranasadihajivand@gmail.com Hamedan University of Medical Sciences scientific Jeyran Asadi hajivand
No. 17, Behrouz Mohammadi Alley., Ghaedi Brothers Ave
Tehran Iran (Islamic Republic of) 1149774611 +98 21 7762 1301 j.asadi@edu.umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Inguinal Incision should be used for surgery The wound should be classified as a Clean Wound The patient's age should be from 1 to 8 years In case of Inguinal Hernia, It should be Indirect Hernia should be repaired by Sac Ligation without using Mesh It should be possible to have In-person and Telephone access with the Patient 1 year 8 years Both The Patient's Parents do not give Informed Consent Patients having Congenital Anomaly Patients having Immunodeficiency Diseases Patients having Hematology and Coagulation disorders Patients having Skin Disorders Other Other Intervention group: skin suture is performed once at the end of surgery with Vicryl thread. The thread used is VICRYL RAPIDE W9940 type and produced by ETHICON company. It is manufactured by ETHICON, LLC, CE 0086, XZW9940.1 AND LOT number of AK7988. The thread size is 3.0 and the thread length is 75 cm. The thread needle is 26 mm and 3/8 circle and reverse cutting type. Control group: Skin suture is done once at the end of surgery with nylon thread. The thread used is produced by TEB KEYHAN company. It is manufactured by NASG TEB KEYHAN, NO 1467/2, Golchin 2, Golriz 2, West Ghazali blvd, Eshtehard Industrial, Karaj, Iran. The thread size is 3.0 and the thread length is 75 cm. The thread needle is 26 mm and 3/8 circle and reverse cutting type. Wound healing score in REEDA scale. Timepoint: in 24 hours after the operation and on the third, fifth and seventh days after the operation. Method of measurement: REEDA wound healing scale. Scar score in Vancouver Scar Scale. Timepoint: 15th and 30th day after the operation. Method of measurement: Vancouver Scar Scale. Surgeon satisfaction. Timepoint: 30th day after the operation. Method of measurement: A 5-point Likert scale developed by the researcher. Hamedan University of Medical Sciences Approved 2022-12-04 Ethics committee of Hamadan University of Medical Sciences No. 17, Behrouz Mohammadi Alley., Baradaranr Ghaedi Ave Tehran Tehran Iran (Islamic Republic of)