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IRCT20221008056113N1 IRCT 2023-07-13 Mashhad University of Medical Sciences Evaluation of the effect of amniotic membrane allograft on duration and costs of treatment in pilonidal disease compared with conventional methods Comparing the efficacy of amniotic membrane allograft with conventional dressing methods on the duration of treatment of pilonidal sinus patients 2023-07-23 anticipated 30 Complete https://irct.ir/trial/66396 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method was used, in which the patients were divided into 6 blocks, and then the list of blocks was written and numbers were assigned to them. Then a random number between 1 and 5 is selected and finally the treatment allocation list is determined based on the previous random numbers. The randomization unit is individual, and the randomization tool is a table of random numbers. The random sequence was created using the table of random numbers through www.randomization.com. The method of concealment is the allocation of sealed envelopes, Blinding description: The person allocating the sample to the groups and the person analyzing the data do not know the type of intervention. Regarding the type of intervention, the participants and the medical personnel taking care of them as well as the main researcher (surgeon) are aware of the type of intervention. 3 Pilonidal sinus. Intervention group, in addition to the usual care of the wound, amnion-chorion dry sheets are used for dressing, and this product is provided under the brand name Life Cell from Bazar Teb Company. For this study, batch C4C6C7 of this. Yes - There is a plan to make this available What will be shared: After the completion of the study, the data related to the duration of wound healing in the study and control groups will be shared. A picture of the stages of wound healing in the intervention group will be taken at each visit and will be shared after making the people unidentifiable. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: access to these data will be allowed for surgeons and researchers in the field of wound healing, especially researchers who intend to conduct research on the effect of using amniotic membrane in other types of surgical wounds. Where to obtain: The results of this research will be published on the website rpis.research.ac.ir. These results can also be achieved by calling one of the researchers of this project named Zahra Kargar and submitting a request. How to obtain: The data can be obtained by registering in the rpis.research.ac.ir system and searching for the title of this research. You can also get these data by sending a massage to the number 00989215569742 and submitting your research project proposal. Comments:
public Asa Yousefi
Ghaem Hospital, Ahmad Abad Ave, Mashhad town
Mashhad Iran (Islamic Republic of) 9176699311 +98 51 3840 9642 yousefia952@mums.ac.ir Mashhad University of Medical Sciences scientific Asa Yousefi
Ghaem Hospital, Ahmad Abad Ave, Mashhad town
Mashhad Iran (Islamic Republic of) 9176699311 +98 51 3840 9642 Yousefia952@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old with the first manifestation of pilonidal sinus disease one week after surgery Surgical wounds with a size of 4 x 4 cm and larger without infection 18 years no limit Both Pilonidal sinus with abscess formation Underlying chronic diseases that disrupt wound healing, such as diabetes and connective tissue diseases. Glucocorticoid consumption during the study period L05.9 Pilonidal cyst and sinus without abscess Treatment - Devices Intervention group, in addition to the usual care of the wound, amnion-chorion dry sheets are used for dressing, and this product is provided under the brand name Life Cell from Bazar Teb Company. For this study, batch C4C6C7 of this The time required for wound healing until the complete formation of the epithelium. Timepoint: After the initial visit one week after surgery, patients are examined two weeks later (i.e. the third week after surgery) and then weekly for 6 to 8 weeks (depending on the time required for wound healing). Method of measurement: Examination of wounds is performed by a single experienced nurse and familiar with the wound healing process who will receive the necessary training. Total cost for wound care, including the cost of purchasing dressings, antibiotics, and painkillers, as well as the cost of weekly visits. Timepoint: At the end of the study. Method of measurement: All these costs are calculated regardless of insurance, and the patients will be asked at each visit and compared in two groups at the end of the complete recovery process. Mashhad University of Medical Sciences Approved 2022-04-12 Ethics committee of Mashhad University of Medical Sciences Qaem hospital, Ahmad abad Ave, Mashhad Town Mashhad Razavi Khorasan Iran (Islamic Republic of)