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

Comparing the Effect of Suturing the Inguinal Skin Incision with Vicryl and Nylon Sutures in Wound Healing, Cosmetic Results and Surgeon Satisfaction in Children Undergoing Surgery

Clinical trial with two parallel intervention groups, double-blind, randomized, on 56 patients. For simple randomization, lottery and sealed envelopes are used.

Candidates for surgery in Bahrami Children's Hospital affiliated to Tehran University of Medical Sciences, with inclusion criteria and informed consent, are assigned to one of the study groups. After the surgery, Inguinal Skin Incision is sutured with either Nylon or Vicryl thread. Surgeon and Technique is the same. After wound dressing, the patient is transferred to the ward. 24 hours later the wound healing questionnaire is completed and also on the third, fifth and seventh days after the operation. On the 15th and 30th day, the scar questionnaire is completed and on the 30th day, surgeon satisfaction is obtained. Data collection is based on operating room, ward and clinic. The participants, the outcome assessor, and the statistical analyst are blinded to the allocation of groups.

Inclusion criteria: The use of Inguinal Incision for surgery, Clean Wound Classification, age range of 1 to 8 years, Indirect Hernia Type, Hernia Sac Ligation repair method without using Mesh, and the possibility of telephone and in person access after the operation are . Exclusion criteria: also include parents' lack of consent, Congenital Anomalies, Immunodeficiency Diseases, Hematology and Coagulation Diseases and Skin Disorders.

There are two intervention groups, in one of them, after the end of the surgery, the Inguinal Skin Incision is sutured with Vicryl thread and in the other group, with Nylon thread.

Wound Healing Rate, Scar, Surgeon satisfaction

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.

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.

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Corresponding author: jeyranasadihajivand@gmail.com

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