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IRCT20170703034873N3 IRCT 2022-10-09 Zahedan University of Medical Sciences The effect of the implementation a care bundle for the prevention of caesarean wound infection The effect of the implementation a care bundle for the prevention of caesarean wound infection 2022-09-23 anticipated 60 Complete https://irct.ir/trial/65166 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be selected using the available sampling method, using the research unit's selection checklist and based on the criteria for entering the study and among women candidates for non-emergency caesarean section. Then they will be assigned to two intervention and control groups by random allocation method and using permutation blocks. Considering that two groups are considered in the study, patients are allocated in 6 cases of blocks of four, A is the intervention group (receiving a preventive care package from surgical site infection) and B is the control group, for example (AABB, ABAB, BBAA,...), in each block, there will be two people from each group. The order of the blocks will be determined randomly using a table of random numbers, and then the patients will be divided into two intervention and control groups based on the blocks. N/A The effect of the implementation of the care package for the prevention of caesarean section wound infection. Intervention 1: Intervention group: The recipient of the infection prevention care package will be the operation site, so that pre-surgery care will be provided for patients according to the care package, after the patient is called to the operating room, intra-operative care will be provided, and after the surgery, post-surgery care will be provided. It will be done in the recovery room and women's surgery department. To confirm or rule out wound infection, 24 hours after the operation and every dressing change (as long as the patient is in the inpatient ward) and on the eighth day after surgery (when the sutures are removed), check the wound for the occurrence of infection using a check list. The wound and the REEDA tool will be performed. Basically, the patient's surgical incision will be observed by the researcher (surgeon and nurse) after removing the wound dressing and before using the wound washing solutions, and after completing the wound examination checklist, washing and dressing the wound is done According to the discharge of the patients, for the 30-day post-surgery review, the symptoms of wound infection will be taught to the patients, and a checklist will be given to the patients to complete the training provided about the surgical wound and On the thirtieth day, when the patient is visited again by the researcher at the women's clinic or home, present it to the researcher. The researcher will contact the patients from the time of discharge until 30 days after the surgery and will provide the necessary explanations on how to care for the wound and remind the patient to complete the checklist. Regarding the implementation of the care package, of course, not all cases can be done by the researcher, especially care during surgery, but the correct implementation of the package in these cases will be under the supervision of the researcher. Intervention 2: Control group: First, demographic, pregnancy and surgical information will be collected through interview and patient file study, and they will receive all the usual and routine care of the surgical department and operating room, and the examination of the surgical incision in terms of signs of infection is similar to the intervention group, in the first 24 hours and After removing the dressing, the wound is washed every time and when the stitches are removed and on the 30th day. The data collection method will be using the information recorded in the patient's hospital record and directly observing the wound and completing the checklist. If the patient has signs of redness, clear swelling more than 0.5 cm from the opening of the wound, local pain or pain when touching, increased heat. Around the wound, there was an increase in body temperature of more than 37.7 degrees Celsius with or without chills, purulent secretions or a bad smell from the wound, this wound is considered infected. The 30th day will be the end of the study period of the implementation of the care package in the intervention group, and of course the control group will also be examined in the same time period. Each patient will be monitored for one month after surgery. A pamphlet containing the symptoms of wound infection along with education will be given to the patients during discharge so that they can refer to them if any of the symptoms of infection occur. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Fariba Yaghoubinia
Mashahir Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3343 0059 yaghoubinia@zaums.ac.ir Zahedan University of Medical Sciences scientific Fariba Yaghoubinia
Mashahir Square
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3343 0059 yaghoubinia@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Candidates for non-emergency cesarean section due to obstetric and non-obstetric indications Patient consent to participate in the study Being at least 18 years old singleton pregnancy Gestational age greater than or equal to 37 weeks Not suffering from an underlying disease such as severe liver/kidney disorders/diabetes and severe anemia (Hct<33% or Hb<11g/dl) Not using immunosuppressive drugs (cortones) No history of infectious disease and severe malnutrition in the last 6 months The patient's BMI should be less than 35 Failure to detect placenta accreta or placenta previa in ultrasound before caesarean section 18 years no limit Female Hospitalization for more than 1 week after cesarean section Receiving blood products within the last 10 days Fever above 38 degrees from the time of admission to 48 hours after cesarean section Not being discharged from the first 24 hours after surgery due to the presence of any birth complications Non-referral in the one-month follow-up of the patient O86.0 Infection of obstetric surgical wound Prevention Prevention Intervention group: The recipient of the infection prevention care package will be the operation site, so that pre-surgery care will be provided for patients according to the care package, after the patient is called to the operating room, intra-operative care will be provided, and after the surgery, post-surgery care will be provided. It will be done in the recovery room and women's surgery department. To confirm or rule out wound infection, 24 hours after the operation and every dressing change (as long as the patient is in the inpatient ward) and on the eighth day after surgery (when the sutures are removed), check the wound for the occurrence of infection using a check list. The wound and the REEDA tool will be performed. Basically, the patient's surgical incision will be observed by the researcher (surgeon and nurse) after removing the wound dressing and before using the wound washing solutions, and after completing the wound examination checklist, washing and dressing the wound is done According to the discharge of the patients, for the 30-day post-surgery review, the symptoms of wound infection will be taught to the patients, and a checklist will be given to the patients to complete the training provided about the surgical wound and On the thirtieth day, when the patient is visited again by the researcher at the women's clinic or home, present it to the researcher. The researcher will contact the patients from the time of discharge until 30 days after the surgery and will provide the necessary explanations on how to care for the wound and remind the patient to complete the checklist. Regarding the implementation of the care package, of course, not all cases can be done by the researcher, especially care during surgery, but the correct implementation of the package in these cases will be under the supervision of the researcher. Control group: First, demographic, pregnancy and surgical information will be collected through interview and patient file study, and they will receive all the usual and routine care of the surgical department and operating room, and the examination of the surgical incision in terms of signs of infection is similar to the intervention group, in the first 24 hours and After removing the dressing, the wound is washed every time and when the stitches are removed and on the 30th day. The data collection method will be using the information recorded in the patient's hospital record and directly observing the wound and completing the checklist. If the patient has signs of redness, clear swelling more than 0.5 cm from the opening of the wound, local pain or pain when touching, increased heat. Around the wound, there was an increase in body temperature of more than 37.7 degrees Celsius with or without chills, purulent secretions or a bad smell from the wound, this wound is considered infected. The 30th day will be the end of the study period of the implementation of the care package in the intervention group, and of course the control group will also be examined in the same time period. Each patient will be monitored for one month after surgery. A pamphlet containing the symptoms of wound infection along with education will be given to the patients during discharge so that they can refer to them if any of the symptoms of infection occur. Caesarean section wound infection. Timepoint: For patients, pre-surgery care will be provided according to the care package, after the patient is called to the operating room, intra-operative care will be provided, and after the surgery, post-surgery care will be provided in the recovery room and women's surgery department. Method of measurement: Data collection tool The data collection tool in this study is a questionnaire consisting of four sections A: Patient demographic information form B: Patient pregnancy information form C: Patient surgery information form and surgical site infection checklist and REEDA tool will be. Zahedan University of Medical Sciences Approved 2022-08-28 Ethics Committee of Zahedan University of Medical Sciences Zahedan, Zahedan University of Medical Sciences and Medical Services campus administrative complex, Khaleej Fars Blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)