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IRCT20210508051227N1 IRCT 2022-03-11 Kermanshah University of Medical Sciences Comparative study of surgical site infection incidence in patients with perforated peptic ulcer that undergo primary intention versus delayed primary(tertiary) intention Comparative study of surgical site infection incidence in patients with perforated peptic ulcer that undergo primary intention versus delayed primary(tertiary) intention 2022-02-20 anticipated 80 Complete https://irct.ir/trial/56250 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Numbers with random sequences are generated by PASS software and random number table and are encrypted into envelopes. The patient is then asked to choose one of the envelopes completely randomly (this part is done by one of the operating room staff or a doctor who does not know the details of the plan) and based on the number in the envelopes, the surgical method is selected, Blinding description: Primary intention method is considered as the basic method and delayed primary intention method is considered as the intervention method. Due to the assignment of encrypted envelopes containing numbers determining the type of surgery to each patient, as a result, patients are unaware of the type of intention method assigned to them.(Before presenting the envelopes to the patients, both types of surgical procedures and their complications will be explained to the patients and the consent of both surgeries will be taken from them). Considering that the intervention is a type of surgical procedure that the difference between them is in the kind of surgical incision and unlike the medical interventions, the patient will notice the surgical method after regaining consciousness according to the explanations given to him before the surgery in relation to the two existing types of surgery. As a result, blinding is performed only until surgery. N/A Perforated peptic ulcer. Intervention 1: In this group, delayed primary intention is performed. In this way, after the perforation is repaired, all the layers of the abdominal wall are closed after surgery, and only the skin of the abdominal wall remains open for 5 days, and then it is sutured. Intervention 2: In this group, the primary intention method is performed. In this way, after perforation repair, all layers of the abdominal wall, including the skin, are sutured in the operating room immediately after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more data is available
public Ali Toolabi
No 20 , 11metri dovvom , mousa kalantari ave
Kermanshah Iran (Islamic Republic of) 6715746687 +98 921 337 8018 ali.toolabi@yahoo.com Kermanshah University of Medical Sciences scientific Ali Toolabi
No 20 , 11 Metri Dovvom , Mousa Kalantari Ave
Kermanshah Iran (Islamic Republic of) 6715746687 +98 921 337 8018 ali.toolabi@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients with perforated peptic ulcer Presence of peritonitis clinical sign that confirmed by surgeon Presence of paraclinical findings that confirms peritonitis no limit no limit Both Presence underlying disease like HIV , Diabetes , hepatitis , collagen vascular disease Use antibiotics for one recent month Hospitalization for 3 recent month People with BMI more than 30 Using drugs like immunosuppressive or corticosteroid K27.1 Acute peptic ulcer, site unspecified, with perforation Treatment - Surgery Treatment - Surgery In this group, delayed primary intention is performed. In this way, after the perforation is repaired, all the layers of the abdominal wall are closed after surgery, and only the skin of the abdominal wall remains open for 5 days, and then it is sutured. In this group, the primary intention method is performed. In this way, after perforation repair, all layers of the abdominal wall, including the skin, are sutured in the operating room immediately after surgery. Incidence of surgical site infection. Timepoint: 14 days. Method of measurement: observation. Kermanshah University of Medical Sciences Approved 2021-03-09 Research Ethics Committees of Kermanshah University of Medical Sciences No 20 , 11 mtri dovvom alley , mousa kalantari ave kermanshah Kermanshah Iran (Islamic Republic of)