Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-10
First Post:
2023-06-07
Brief Title:
Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section
Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Organization:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study Overview
Official Title:
Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
The objective of this study will be to compare two methods of skin incisions during the first caesarean section CS that is scalpel and diathermy assessing differences in blood loss during incision incisional time total surgery time post-operative pain wound healing complications and cosmetic outcomes
Detailed Description:
The scalpel has been historically used as the primary cutting tool during caesarean section CS However advancements in surgical devices have introduced alternatives such as the option to make a diathermic cut using electrosurgical units
General surgeons have extensively demonstrated the advantages of diathermy over the scalpel for abdominal wall incisions including faster opening time reduced incisional blood loss decreased post-operative pain and a comparable wound complication rate
In obstetrics there is a scarcity of evidence in this regard and no consensus or guidelines have been established regarding the optimal method for making a transverse abdominal incision during the first elective CS Currently the choice between using a scalpel or diathermy remains at discretion of the obstetric surgeon The objective of this study will be to compare both methods of skin incisions during the first CS assessing differences in blood loss during incision incisional time total surgery time post-operative pain wound healing complications and cosmetic outcomes
General surgeons have extensively demonstrated the advantages of diathermy over the scalpel for abdominal wall incisions including faster opening time reduced incisional blood loss decreased post-operative pain and a comparable wound complication rate
In obstetrics there is a scarcity of evidence in this regard and no consensus or guidelines have been established regarding the optimal method for making a transverse abdominal incision during the first elective CS Currently the choice between using a scalpel or diathermy remains at discretion of the obstetric surgeon The objective of this study will be to compare both methods of skin incisions during the first CS assessing differences in blood loss during incision incisional time total surgery time post-operative pain wound healing complications and cosmetic outcomes
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