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Trial no.:
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PACTR202203595456214 |
Date of Registration:
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16/03/2022 |
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Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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| TRIAL DESCRIPTION |
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Public title
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Caesarean Delivery Surgical Site Infection Product Trial:“The CDSSI Trial”
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| Official scientific title |
THE ROLE OF IRRISEPT IN REDUCING SURGICAL WOUND INFECTION FOLLOWING CAESAREAN SECTION IN FEDERAL MEDICAL CENTRE, YENAGOA SOUTH- SOUTH NIGERIA |
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Brief summary describing the background
and objectives of the trial
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Primary Objective: To reduce CDSSI rates during the 30 days post delivery period when compared retrospectively to the CDSSI rate pre-trial.
Secondary Objective: The secondary objectives will focus on measuring the reduced length of stay, actual costs associated with CDSSI, and extrapolated costs to the healthcare facility
Caesarean deliveries are the most frequent surgical procedure performed in numerous countries and regions of the world.[1, 2] The infection risk associated with a caesarean delivery has been estimated to carry from 5 to 20-fold higher risk than for vaginal deliveries. Thus raising the maternal mortality and morbidity risk.[3]
In a study by Koigi-Mamamu and colleagues, they reported surgical site infection rates as high as 20% in women having a caesarean delivery in Africa.[4] Across the African continent, the caesarean delivery surgical site infection (CDSSI) rate is reported to vary widely.
CDSSIs prolong hospital stays, increases costs, and places a heavy burden on health care facilities that may have limited-resources available.[1, 5] In the Study by Brubaker et al of over 1.1 million caesarean deliveries, found a significant correlation associated in those “Women who did not labor were more likely to receive antibiotics than those who had a cesarean delivery after labor (66% compared with 44%, P<.001).”[3]
In a quality improvement study by Mangold and colleagues in 2020, they used a commercially available and FDA-cleared irrigation solution containing 0.05% chlorhexidine gluconate in 99.95% sterile water to lavage the wounds of caesarean deliveries, focused on decreasing the CDSSI rate. What this study discovered was that the 0.05% chlorhexidine gluconate wound irrigation process helped protect the mother from a CDSSI when antibiotics were not given at the proper time.[6]
Sub-Saharan African countries face a women’s health crisis associated with CDSSIs as the rate of caesarean deliveries increase.[7] With CDSSI and associated death rates. |
| Type of trial |
RCT |
| Acronym (If the trial has an acronym then please provide) |
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| Disease(s) or condition(s) being studied |
Infections and Infestations,Pregnancy and Childbirth,Surgery |
| Sub-Disease(s) or condition(s) being studied |
Surgical Site Infection |
| Purpose of the trial |
Prevention |
| Anticipated trial start date |
01/03/2022 |
| Actual trial start date |
01/04/2022 |
| Anticipated date of last follow up |
30/09/2022 |
| Actual Last follow-up date |
31/10/2022 |
| Anticipated target sample size (number of participants) |
200 |
| Actual target sample size (number of participants) |
200 |
| Recruitment status |
Recruiting |
| Publication URL |
file:///C:/Users/Angela%20Unufe-Kennedy/Downloads/Mangold%20T%20%20et%20al.%20%20Standardizing%20intraoperative%20irrigation%20with%200.05%25%20in%20caesarean%20deivery%20to%20reduce%20surgical%20site%20infections%20(2).pdf |
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