Cesarean Section ComplicationsNCT06257940
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection
An observational study of Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Cesarean Section Complications
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Adult
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.
Who may be able to join
- Age: 20-35 years.
- Non obese with body mass index (BMI) < 30 kg/m2.
- Term pregnancy ≥ 37 weeks +0 days.
- Singleton.
- Viable fetus.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
assiut University
Asyut
Ahmed Abu El-Fadl El-Sayed, assistant professor, 01028807092, drahmedmohamed83@gmail.com
About this study
Official 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
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
- 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 .
- 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 .
- 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).
- 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.
- One of the most serious complications after CS is wound complication it varies from 3 to 30% .
- 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 .
- 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 .
- 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 .
- 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 .
- 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 .
- 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
- Conditions
- Cesarean Section Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 4 weeks after cesarean sections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jan 2023
- Primary completionMar 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Hamada Mohamed, Assiut University
- Investigators
- Ahmed Abu El-Fadl El-Sayed, assistant professor, Study director, obstetrics & gynacology depatmen assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257940
- Sponsor's protocol ID
- 04-2023-200359
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 35670438Betran 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 26849801Kawakita 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 28690864Ban 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06257940
- Acronym / sponsor ID
- 04-2023-200359
- Conditions
- Cesarean Section Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the impact of changing sterile gloves at the time of wound closure on reduction of SSI in women undergoing elective CS.
Detailed description
- 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 .
- 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 .
- 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).
- 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.
- One of the most serious complications after CS is wound complication it varies from 3 to 30% .
- 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 .
- 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 .
- 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 .
- 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 .
- 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 .
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Age: 20-35 years.
- Non obese with body mass index (BMI) < 30 kg/m2.
- Term pregnancy ≥ 37 weeks +0 days.
- Singleton.
- Viable fetus.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection
Time frame: within 4 weeks after cesarean sections
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 35670438Wahdan 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.
- Background: PubMed 26849801Betran 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.
- Background: PubMed 28690864Kawakita 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.
- Background: PubMed 27915053Ban 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.
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Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abu El-Fadl El-Sayed, assistant professor study director
obstetrics & gynacology depatmen assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact : Naglaa Hamada Mohamed Ahmed, master (+201151786690, drnaglaahamada@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection (time frame: within 4 weeks after cesarean sections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257940, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.