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RecruitingNCT06257940Updated Feb 14, 2024

Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection

An observational study in Cesarean Section Complications, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

Assessment of the impact of changing sterile gloves at the time of wound closure on reduction of SSI in women undergoing elective CS.

Read the detailed description
  1. CS is the most common major operation preformed worldwide. In daily obstetric practice. It account for up to 60% of all births in some countries .
  2. Previous study reported that Egypt has the third highest CS rate (54%) in the world and lacks a standard classification system to analyze CS rates, following Do-minican Republic (56.4 percent) and Brazil (55.6 percent). Within the Arab region, rates of CS are far higher in Egypt than any other Arab country .
  3. In another study, the CS rate in Egypt was estimated at 55.1%, and the highest rate was 67.8% in Behira and the lowest was 49.0% in Assiut. In most governorates, the CS rate was higher in rural than in urban areas, but the difference was not significant. High CS rates were significantly related to higher social class and lower number of children (≤ 3).
  4. The percentage of "unjustified" caesarean deliveries has exceeded 62 percent of total deliveries in Egypt, many of which could have been done naturally. In August 2022, the Central Agency for Public Mobilization and Statistics (CAPMAS) reported a noticeable increase in C-sections in recent years. CAPMAS found that C-sections increased to 72 percent of all deliveries in 2021, up from 52 percent in 2014. The agency also found that C-sections in rural areas increased to 84 percent of all deliveries in 2021, up from 70.6 percent in 2014.
  5. One of the most serious complications after CS is wound complication it varies from 3 to 30% .
  6. It may be infectious as SSI or non-infectious as hematoma, seroma, and wound separation. These complications cause increase hospital stay or readmission also, maternal morbidaty and cost are increased .
  7. SSIs are a common cause of health care-associated infection. The United States Centers for Disease Control and Prevention (CDC) has developed criteria that define SSI as infection related to an operative procedure that occurs at or near the surgical incision within 30 days of the procedure or within 90 days if prosthetic material is implanted at surgery. SSIs are often localized to the incision site (superficial/deep incisional SSI) but can also extend into deep tissues .
  8. There were numerous recommendations for SSI prevention efforts in recent World Health Organization (WHO) guidelines, however most of these interventions were not well-supported by high-quality evidence .
  9. WHO recommendations for change of gloves at the time of fascial closure were identified as the priority recommendations. Three studies have been published to date, all suggesting to a benefit, however the particular evidence for SSI reduction with glove change prior to fascial closure is limited, consisting primarily of small RCTs with a high risk of bias .
  10. The CDC, WHO, and NICE guidelines do not recommend changing gloves as part of routine care due to the poor evidence data base. The executive summary of the 2017 WHO Guidelines on SSI Reduction Practice indicates that well-designed RCTs would be requested because there is no direct proof of the usefulness of sterile surgical gloves changing prior to wound closure .
  11. The CDC healthcare-associated infection (HAI) prevalence survey found that there were an estimated 110,800 SSIs associated with inpatient surgeries in 2015. SSI is the most costly HAI type with an estimated annual cost of $3.3 billion, and extends hospital length of stay by 9.7 days, with cost of hospitalization increased by more than $20,000 per admission
02

Conditions studied

  • Cesarean Section Complications
03

In context

Surgical Wound Infection

670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.

This study's planned enrollment of 220 is close to the median of 237 across 128 observational studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

study will be conducted in Assuit Women Health Hospital We will recruit a pregnant women attending for cesarean sections according to the previous inclusion and exclusion criteria.

Inclusion criteria

  • Age: 20-35 years.
  • Non obese with body mass index (BMI) \< 30 kg/m2.
  • Term pregnancy ≥ 37 weeks +0 days.
  • Singleton.
  • Viable fetus.

Exclusion criteria

Exclusion Criteria:

  • Obese women with body mass index (BMI) ≥ 30 kg/m2.
  • Anemic women with hemoglobin level \< 10.5 g/dl.
  • Immuno-compromised women with medical disorders with pregnancy as diabetes mellitus, hypertension, cardiac, hepatic or renal disorders.
  • Women with anticipated pelvic adhesions as cases with history of endometriosis, pelvic inflammatory diseases or more than previous 3 CSs.
  • Multifetal pregnancy.
  • Emergency CS.
  • Women with antepartum hemorrhage (placenta previa or placenta accrete spectrum disorder).
  • Obstetric cases with increased risk of infection as premature rapture of membranes (PROMs).
  • Women refusing to participate in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (estimated)
Patient registry
No

Groups and cohorts

  • intra-operative glove changing group

    in which, the surgeon will replace his/her outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure

  • usual care group

    in which, surgeon won't change his/her gloves before abdominal closure

06

What researchers measure

Primary outcomes

  1. Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection

    Composite end point of any wound complication i.e. SSI occurring within one and three weeks following delivery. These wound complications include wound seroma, wound hematoma, wound infection, skin separation of at least 1 cm or other incisional abnormality requiring a bedside procedure to treat.

    Time frame: within 4 weeks after cesarean sections

07

Study locations

1 of 1 sites recruiting
  • assiut University
    Assiut, Egypt
    Recruiting
08

References and documents

Publications

  • Wahdan M, Hakim S, El Gaafary M, Sos D, Wassif G, Hussein W, Mokhtar A, Hussein A, El Awady M, Rady M, Anwar W. Rising trends in Caesarean section in 6 Egyptian governorates. East Mediterr Health J. 2022 May 29;28(5):336-344. doi: 10.26719/emhj.22.012. PubMed 35670438 ↗
  • Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016. PubMed 26849801 ↗
  • Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017. PubMed 28690864 ↗
  • Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74. doi: 10.1016/j.jamcollsurg.2016.10.029. Epub 2016 Nov 30. No abstract available. PubMed 27915053 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257940
Lead sponsor
Assiut University
Responsible party
Naglaa Hamada Mohamed (doctor, Assiut University) — Principal investigator
First posted
Feb 14, 2024
Start date
Jan 1, 2023
Primary completion
Mar 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
Feb 14, 2024

Study contacts

: Naglaa Hamada Mohamed Ahmed, master
Contact
drnaglaahamada@gmail.com
+201151786690
Ahmed Mohamed Ali Nasr, professor
Contact
ahmedmanasr@gmail.com
01005212140
Ahmed Abu El-Fadl El-Sayed, assistant professor
study director · obstetrics & gynacology depatmen assiut university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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