Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257940
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Brief Title:
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 564 percent and Brazil 556 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 551 and the highest rate was 678 in Behira and the lowest was 490 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 706 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 superficialdeep 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 110800 SSIs associated with inpatient surgeries in 2015 SSI is the most costly HAI type with an estimated annual cost of 33 billion and extends hospital length of stay by 97 days with cost of hospitalization increased by more than 20000 per admission
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 564 percent and Brazil 556 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 551 and the highest rate was 678 in Behira and the lowest was 490 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 706 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 superficialdeep 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 110800 SSIs associated with inpatient surgeries in 2015 SSI is the most costly HAI type with an estimated annual cost of 33 billion and extends hospital length of stay by 97 days with cost of hospitalization increased by more than 20000 per admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None