NCT06257940

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Cesarean Section Complications

Outcome Measures

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.

    within 4 weeks after cesarean sections

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

assiut University

Asyut, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 35670438BACKGROUND

  • 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.

    PMID: 26849801BACKGROUND

  • 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.

    PMID: 28690864BACKGROUND

  • 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.

    PMID: 27915053BACKGROUND

Study Officials

  • Ahmed Abu El-Fadl El-Sayed, assistant professor

    obstetrics & gynacology depatmen assiut university

    STUDY DIRECTOR

Central Study Contacts

: Naglaa Hamada Mohamed Ahmed, master

CONTACT

+201151786690drnaglaahamada@gmail.com

Ahmed Mohamed Ali Nasr, professor

CONTACT

01005212140ahmedmanasr@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

January 1, 2023

Primary Completion

March 1, 2024

Study Completion

January 1, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

EG(1)