Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202407629387640 Date of Approval: 16/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection in Women Undergoing Elective Cesarean Section
Official scientific title Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection in Women Undergoing Elective Cesarean Section; a Prospective Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Among surgical patients, surgical site infections (SSIs) are the most common nosocomial infection, accounting for 38 percent of nosocomial infections. It is estimated that SSIs develop in 2 to 5 percent of the more than 30 million patients undergoing surgical procedures each year (ie, 1 in 24 patients who undergo inpatient surgery in the United States has a postoperative SSI).We aimed to assess the impact of changing sterile gloves at the time of wound closure to reduce SSI in women undergoing elective cesarean section (CS)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Surgical Site Infection
Purpose of the trial Prevention
Anticipated trial start date 01/02/2023
Actual trial start date 15/02/2023
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 283
Actual target sample size (number of participants) 202
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FMASU MS 612023 Ain Shams University Faculty of Medicine Research Ethics Committee -REC- FWA 000017585
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Same glove during skin closure NONE once Group B (usual care group): in which, surgeon didn't change his/her gloves before abdominal closure. patients received appropriate pre-operative antibiotics in the form of cephazolin “1st-generation cephalosporin” (Zinol®, 1 g, vial, PHARCO INTERNATIONAL, Egypt) 30 minutes before skin incision and 12 hours postoperative, betadine (povidone-iodine 10%) skin prep, except where allergies prohibited. Vaginal preparation and cesarean delivery techniques were at the discretion of the attending surgeon. Abdominal closure was considered to begin with the closure of the peritoneum if performed, otherwise with the closure of the abdominal fascia. Skin closure was done using the same glove, Vicryl (polyglactin 910) “an absorbable, synthetic, braided suture, manufactured by Ethicon Inc., a subsidiary of Johnson and Johnson, 2/0 or 3/0 with noncutting curved needle. All women were discharged on the same home treatment in the form of (Augmentin®, Amoxicillin/Clavulanic acid, 1 g, tablet, GlaxoSmithKline GSK, Egypt), metronidazole and proper analgesics. Wound dressing instructions (keep it dry and clean) were given to the patient. All women were advised to come for follow up visit one week post-operative then they were called on their phone after three weeks for second follow up and assessment of incidence of SSI 100 Active-Treatment of Control Group
Experimental Group Changing glove before skin closure NONE once Group A (intra-operative glove changing group): in which, the surgeon replaced his/her outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure. all patients received appropriate pre-operative antibiotics in the form of cephazolin “1st-generation cephalosporin” (Zinol®, 1 g, vial, PHARCO INTERNATIONAL, Egypt) 30 minutes before skin incision and 12 hours postoperative, betadine (povidone-iodine 10%) skin prep, except where allergies prohibited. Vaginal preparation and cesarean delivery techniques were at the discretion of the attending surgeon. Abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia. The change of gloves were prior to skin closure which was done using Vicryl (polyglactin 910) “an absorbable, synthetic, braided suture, manufactured by Ethicon Inc., a subsidiary of Johnson and Johnson, 2/0 or 3/0 with noncutting curved needle. All women were discharged on the same home treatment in the form of (Augmentin®, Amoxicillin/Clavulanic acid, 1 g, tablet, GlaxoSmithKline GSK, Egypt), metronidazole and proper analgesics. Wound dressing instructions (keep it dry and clean) were given to the patient. All women were advised to come for follow up visit one week post-operative then they were called on their phone after three weeks for second follow up and assessment of incidence of SSI 102
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-pregnant women aged 20-35 years; non-obese with body mass index (BMI) < 30 kg/m2 with term pregnancy ≥ 37 weeks +0 days; singleton and viable fetuses were enrolled. 1-obese women with body mass index (BMI) ≥ 30 kg/m2. 2-anemic women with hemoglobin level < 10.5 g/dl 3-immuno-compromised women with medical disorders with pregnancy as diabetes mellitus, hypertension, cardiac, hepatic or renal disorders. 4- Women with anticipated pelvic adhesions as cases with history of endometriosis, pelvic inflammatory diseases or more than previous 3 CSs. 4- multifetal pregnancy 5- emergency CS, with antepartum hemorrhage (placenta previa or placenta accrete spectrum disorder). 6-obstetric cases with increased risk of infection as premature rapture of membranes (PROMs). 7- woman who refused to participate in the study or write consent Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/02/2023 Ain Shams University faculty of Medicine Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
38 Abassyia Square Next To El Nour Mosque Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the incidence of SSSI, which included wound seroma, wound hematoma wound infection, and skin separation. 1 st postoperative week and 3 weeks post-operative
Secondary Outcome The secondary outcomes were febrile morbidity, cellulitis, the prescription of antibiotics, period of hospital stay, and cost. Sample Size Justification: Using the EPI Info 7 software for sample size calculation, with a power of 80% and an alpha error of 0.05, and based on the study by Hameed et al. in 2020, the anticipated incidence of wound infection in the intervention group is 5% and in the control group is 18.8% [13]. A sample size of 100 women per group was necessary to detect the difference between the two groups. To account for an expected 10% loss of follow-up, the sample size was increased to 110 women per group. Group A, the intra-operative glove changing group, involves the surgeon replacing their outer surgical gloves with a new pair of sterile gloves just before abdominal closure. Meanwhile, Group B, the usual care group, entails the surgeon not changing their gloves before abdominal closure. 1 st postoperative week and 3 weeks post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University 38 elabassia Next to El NOUR mosque Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain shams University 38 elabassia Next to El NOUR mosque Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Maternity Hospital and Adam International Hospital 38 Abbasiya Street Near El Nour Mosque Cairo 11591 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Abd ElAal F61624716@gmail.com 00201110600332 Abbaseyya Square
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer Obestatrics and Gynecology Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Mustafa Abbas Abbassmostafa02@gmail.com 00201110600332 Hadaque El Qubba
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer Obestatrics and Gynecology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Alaa ElDin ElFeky Fiky3487@gmail.com +201110600332 Hadeq El Qubba
City Postal code Country Position/Affiliation
Cairo Egypt lecturer obestatrics and gynecology Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ahmed Sherif cairotrade2050@gmail.com 00966564820942 Hadaque El Qubba
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer Obestatrics and Gynecology Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol One year Immediately following publication, No end date
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://hjog.org/ Yes 10/07/2024 01/06/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/07/2024 Result - 10/07/2024 Result - 10/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information