Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT05439694
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TXA Soaked Gelatin Sponge to Reduce Rectus Sheath Hematoma After C.S. in Patients Using Warfarin
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
The Effect of Using Tranexamic Acid Soaked Absorbable Gelatin Sponge in Reducing Rectus Sheath Hematoma Formation After Cesarean Section in Patients Using Warfarin Compounds
Status:
COMPLETED
Status Verified Date:
2023-02
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:
The aim of this randomized controlled study is to demonstrate the effect of Local application of TXA impregnated in a gelatin sponge in reducing Rectus sheath hematoma formation in patients treated with warfarin following cesarean section.
Detailed Description:
The study will include (63) pregnant women attending for cesarean delivery who will receive anticoagulation (warfarin) postnatally.
Patients included in this study will be subjected to:
\- Informed consent: patients representing the study population will be counselled about the intervention and informed written consent will be taken.
Consenting patients will be subjected to the following:
1\. Detailed personal, obstetric and medical and surgical history. 2- Examination: General Examination.
* Vital signs: Blood pressure, pulse and temperature.
* Weight, height, BMI.
* Abdominal examination for assessment of fundal level. 3. Laboratory Investigations Preoperatively
* CBC, Coagulation Profile, Blood Chemistry. 5. Abdominal Ultrasound: in order to assess the following: a. Gestational age determination. c. Placental site. CS will be done by Senior Obstetricians, Using Standard CS technique, with visceral and parietal peritoneum re-approximation and insertion of a passive intraperitoneal drain. Fascial closure will be done using continuous slowly absorbable sutures. Meticulous hemostasis will be achieved using monopolar cauterization. An active drain (Hemovac®) will be applied in the space between anterior rectus sheath and the rectus abdominis muscle in all patients.
Patients will be randomly assigned into three groups Randomization is done by computer generated random numbers in opaque envelops.
Group 1:
(21) patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle.
Group 2:
(21) patients will have 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) Not impregnated with Tranexamic acid applied locally using the same method as the previous group.
Group 3:
(21) patients will have Neither Gelatin Sponge nor Tranexamic acid applied. Follow up patients for vital signs and manifestations of allergic reactions in the immediate post operative period.
The intraperitoneal drain will be removed after 24 hours in all groups. While the (Hemovac®) drain will be removed after achieving target INR in all groups.
All Patients will be receiving bridging anticoagulation using LMWH(Enoxaparin) alone for 3 days in therapeutic doses (1mg/kg twice daily) to be initiated 12 hours after Surgery in most cases.Then Warfarin will be added on post operative day 3. LMWH will be withdrawn after achieving target INR.
Then comparison between the three groups regarding
* Hemovac® Drain output in cc per day till achieving Target INR Levels for all patients.
* Ultrasound assessment of rectus sheath hematoma if present after achieving Target INR Levels for all patients.
Patients included in this study will be subjected to:
\- Informed consent: patients representing the study population will be counselled about the intervention and informed written consent will be taken.
Consenting patients will be subjected to the following:
1\. Detailed personal, obstetric and medical and surgical history. 2- Examination: General Examination.
* Vital signs: Blood pressure, pulse and temperature.
* Weight, height, BMI.
* Abdominal examination for assessment of fundal level. 3. Laboratory Investigations Preoperatively
* CBC, Coagulation Profile, Blood Chemistry. 5. Abdominal Ultrasound: in order to assess the following: a. Gestational age determination. c. Placental site. CS will be done by Senior Obstetricians, Using Standard CS technique, with visceral and parietal peritoneum re-approximation and insertion of a passive intraperitoneal drain. Fascial closure will be done using continuous slowly absorbable sutures. Meticulous hemostasis will be achieved using monopolar cauterization. An active drain (Hemovac®) will be applied in the space between anterior rectus sheath and the rectus abdominis muscle in all patients.
Patients will be randomly assigned into three groups Randomization is done by computer generated random numbers in opaque envelops.
Group 1:
(21) patients will have 2 pieces of Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) soaked in Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) each sponge will be soaked with one ampoule and applied between the anterior rectus sheath and the rectus abdominis muscle, one sponge on each muscle.
Group 2:
(21) patients will have 2 Gelatin Sponges (SURGISPON®; AEGIS LIFESCIENCES, India) (Size, 40 cm2) Not impregnated with Tranexamic acid applied locally using the same method as the previous group.
Group 3:
(21) patients will have Neither Gelatin Sponge nor Tranexamic acid applied. Follow up patients for vital signs and manifestations of allergic reactions in the immediate post operative period.
The intraperitoneal drain will be removed after 24 hours in all groups. While the (Hemovac®) drain will be removed after achieving target INR in all groups.
All Patients will be receiving bridging anticoagulation using LMWH(Enoxaparin) alone for 3 days in therapeutic doses (1mg/kg twice daily) to be initiated 12 hours after Surgery in most cases.Then Warfarin will be added on post operative day 3. LMWH will be withdrawn after achieving target INR.
Then comparison between the three groups regarding
* Hemovac® Drain output in cc per day till achieving Target INR Levels for all patients.
* Ultrasound assessment of rectus sheath hematoma if present after achieving Target INR Levels for all patients.
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?: