Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595823
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Betadine Versus Saline in Swapping of Subcutaneous Tissue
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Betadine Versus Saline in Swapping of Subcutaneous Tissue to Prevent Surgical Site Infection After Caesarian Section
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Caesarean section is an increasingly common major surgical procedure performed on women Last decade an overall increase of the global rate of caesarean section of up to 312 was reported The risk of maternal morbidity and mortality is higher in caesarean section than in vaginal birth postoperative infection is a common component of morbidity With the increase in caesarean section it is important that the risks to the mother are minimized as far as possible
Women who give birth by caesarean section are exposed to both endogenous internal and exogenous external sources of infection during birth Exposure to a hospital environment places these women at risk of developing hospital-acquired infections The rate of post-caesarean infection has been estimated to be 10 times greater than that after vaginal birth
Women who give birth by caesarean section are exposed to both endogenous internal and exogenous external sources of infection during birth Exposure to a hospital environment places these women at risk of developing hospital-acquired infections The rate of post-caesarean infection has been estimated to be 10 times greater than that after vaginal birth
Detailed Description:
The Centers for Disease Control and Prevention CDC estimates that 27 million surgical procedures are performed in the United States each year The CDCs National Nosocomial Infections Surveillance system reports that surgical site infections are the third most frequently reported nosocomial infection accounting for 14 to 16 of all such infections
Preventing infection by properly preparing the skin before incision is thus a vital part of the overall care given to women during caesarean birth The incidence of abdominal incisional infections following caesarean section ranges from 3 to 15A post-caesarean surgical site infection is a bacterial infection in the surgical incision following an abdominal birth Women who develop a post-caesarean surgical site infection typically experience a temperature of 380C 1004F or higher and lower abdominal pain Abdominal incisional abscesses that develop following caesarean birth usually cause fever on about the fourth postoperative day
In many cases these are preceded by uterine infection and fever persists from the first or second postoperative day Wound redness erythema and drainage may also be present Organisms causing these infections are usually the same as those isolated from amniotic fluid at caesarean birth but hospital-acquired pathogens may also be the cause Some women are more likely than others to develop a post-caesarean surgical site infectionWomen at increased risk include those who are obese have diabetes or an immunosuppressive disorder HIV infection have chorioamnionitis infection of the amniotic fluid and fetal membrane during labor anemia or are taking corticosteroids
Proper preparation of an incision site involves removing surface dirt and oil with a soap or detergent scrub plus applying a topical antimicrobial agent that will reduce the bacterial population to a minimal levelIf prophylactic antimicrobials are given the incidence of abdominal wound infection following cesarean delivery ranges from 2 to 10 percent depending on risk factors Numerous good quality trials have proved that a single dose of an antimicrobial agent given at the time of cesarean delivery significantly decreases infection morbidity
Preventing infection by properly preparing the skin before incision is thus a vital part of the overall care given to women during caesarean birth The incidence of abdominal incisional infections following caesarean section ranges from 3 to 15A post-caesarean surgical site infection is a bacterial infection in the surgical incision following an abdominal birth Women who develop a post-caesarean surgical site infection typically experience a temperature of 380C 1004F or higher and lower abdominal pain Abdominal incisional abscesses that develop following caesarean birth usually cause fever on about the fourth postoperative day
In many cases these are preceded by uterine infection and fever persists from the first or second postoperative day Wound redness erythema and drainage may also be present Organisms causing these infections are usually the same as those isolated from amniotic fluid at caesarean birth but hospital-acquired pathogens may also be the cause Some women are more likely than others to develop a post-caesarean surgical site infectionWomen at increased risk include those who are obese have diabetes or an immunosuppressive disorder HIV infection have chorioamnionitis infection of the amniotic fluid and fetal membrane during labor anemia or are taking corticosteroids
Proper preparation of an incision site involves removing surface dirt and oil with a soap or detergent scrub plus applying a topical antimicrobial agent that will reduce the bacterial population to a minimal levelIf prophylactic antimicrobials are given the incidence of abdominal wound infection following cesarean delivery ranges from 2 to 10 percent depending on risk factors Numerous good quality trials have proved that a single dose of an antimicrobial agent given at the time of cesarean delivery significantly decreases infection morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None