Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303817
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
Double Knots Versus Triple Knots Facia Closure Method is There a Difference in Pain Sensation or Cosmetic Satisfaction
Sponsor:
Adana City Training and Research Hospital
Organization:
Adana City Training and Research Hospital
Study Overview
Official Title:
Double Knots Versus Triple Knots Facia Closure Method During Cesarean Section is There a Difference in Pain Sensation or Cosmetic Satisfaction
Status:
COMPLETED
Status Verified Date:
2024-03
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 study included women who were scheduled for an elective or had an emergency cesarean section Age body mass index BMI obstetric history education status smoking status and C-section indications of the patients were recorded Patients with a previous suprapubic scar medical conditions affecting wound healing such as diabetes or chronic corticosteroid use those needing a vertical incision eg placenta previa individuals with postoperative wound infection or under 18 years old were excluded Data were collected in standardized data form by a research assistant Pre- and post-surgery treatments andor interventions were standardized All patients received antimicrobial prophylaxis with cefazolin before the operation The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion Technical differences such as blunt and sharp dissection uterus exteriorization vs in situ or parietal peritoneum closure were left to the surgeons discretion The procedures for facia closure are as follows in Group I Double knots group the edge of the fascia was determined with a Kocher clamp The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture Figure 2 a-b In Group II Triple knots group the edge of the fascia was fixed with the same suture material instead of the Kocher clamp and the fascia was closed similarly starting from the opposite corner via the second loop Then the loops from the first suture were tied to the second suture Figure 2 c-d After the incision was irrigated with sterile saline solution the subcutaneous space was closed if the thickness was 2 cm or more Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture which was removed on the 10th day postoperatively A closed subcutaneous suction drain was not used in any of the patients Postoperative pain at and around the incision line was measured on the 1st and 10th days postoperatively on the NRS Numeric Rating Scale with 0 being no pain and 10 being the worst pain imaginable The 1st measurements were made face-to-face and the 10th-day evaluation was made via telephone interviews by the same research assistant
Detailed Description:
This prospective randomized control trial was conducted in a single tertiary center between March 2022 and July 2022 The institutional ethics committee approved the study Decision Number 18122022 and all participants provided written informed consent When determining the sample size since there was no literature information type I error was taken as 1 the power of the test was taken as 90 and the effect size between group I and group 2 was taken as 050 moderated a minimum of 106 people in each group and 212 people in total were included in the study 5 The study included women who were scheduled for an elective or had an emergency cesarean section Age body mass index BMI obstetric history education status smoking status and C-section indications of the patients were recorded Patients with a previous suprapubic scar medical conditions affecting wound healing such as diabetes or chronic corticosteroid use those needing a vertical incision eg placenta previa individuals with postoperative wound infection or under 18 years old were excluded Data were collected in standardized data form by a research assistant
The surgeons who participated in the study were obstetricians or senior residents and performed surgeries on patients in all groups and were not blinded because of the nature of the operative procedure A block randomization with a block size of 4-6 and a ratio of 11 was applied Sealed opaque envelopes were used for allocation concealment Scrub nurses opened the envelopes in the operative room just before the skin incision
Pre- and post-surgery treatments andor interventions were standardized All patients received antimicrobial prophylaxis with cefazolin before the operation The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion Technical differences such as blunt and sharp dissection uterus exteriorization vs in situ or parietal peritoneum closure were left to the surgeons discretion The procedures for facia closure are as follows in Group I Double knots group the edge of the fascia was determined with a Kocher clamp The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture Figure 2 a-b In Group II Triple knots group the edge of the fascia was fixed with the same suture material instead of the Kocher clamp and the fascia was closed similarly starting from the opposite corner via the second loop Then the loops from the first suture were tied to the second suture Figure 2 c-d After the incision was irrigated with sterile saline solution the subcutaneous space was closed if the thickness was 2 cm or more Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture which was removed on the 10th day postoperatively A closed subcutaneous suction drain was not used in any of the patients
Postoperative pain at and around the incision line was measured on the 1st and 10th days postoperatively on the NRS Numeric Rating Scale with 0 being no pain and 10 being the worst pain imaginable The 1st measurements were made face-to-face and the 10th-day evaluation was made via telephone interviews by the same research assistant In our clinic we apply paracetamol 500 mg IV and diclofenac sodium intramuscularly IM to our patients postoperatively for pain management Accumulative dosages of requested NSAİ and paracetamol during the hospital stay were also recorded Patient satisfaction with the aesthetic results was assessed using a 10-point scale ranging from 1 very unsatisfied to 10 very satisfied at the 1st and 3rd months postoperatively While scoring patients were asked to score their scars by being reminded of parameters such as color stiffness thickness and irregularity All patients were blinded to which technique was used for facial closure
Statistical analysis Data were analyzed with IBM SPSS V23 IBM Corp Armonk NY USA The normality assumptions were examined with the Kolmogorov-Smirnov test Mann-Whitney U test was used to compare non-normally distributed data in pairs Wilcoxon test was used to compare non-normally distributed data within groups according to two dependent times Pearson chi-square Yates correction and Fishers Exact Test were used to examine categorical variables according to groups Data are expressed as mean standard deviation SD or median minimum-maximum as appropriate P 05 was considered statistically significant
The surgeons who participated in the study were obstetricians or senior residents and performed surgeries on patients in all groups and were not blinded because of the nature of the operative procedure A block randomization with a block size of 4-6 and a ratio of 11 was applied Sealed opaque envelopes were used for allocation concealment Scrub nurses opened the envelopes in the operative room just before the skin incision
Pre- and post-surgery treatments andor interventions were standardized All patients received antimicrobial prophylaxis with cefazolin before the operation The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion Technical differences such as blunt and sharp dissection uterus exteriorization vs in situ or parietal peritoneum closure were left to the surgeons discretion The procedures for facia closure are as follows in Group I Double knots group the edge of the fascia was determined with a Kocher clamp The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture Figure 2 a-b In Group II Triple knots group the edge of the fascia was fixed with the same suture material instead of the Kocher clamp and the fascia was closed similarly starting from the opposite corner via the second loop Then the loops from the first suture were tied to the second suture Figure 2 c-d After the incision was irrigated with sterile saline solution the subcutaneous space was closed if the thickness was 2 cm or more Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture which was removed on the 10th day postoperatively A closed subcutaneous suction drain was not used in any of the patients
Postoperative pain at and around the incision line was measured on the 1st and 10th days postoperatively on the NRS Numeric Rating Scale with 0 being no pain and 10 being the worst pain imaginable The 1st measurements were made face-to-face and the 10th-day evaluation was made via telephone interviews by the same research assistant In our clinic we apply paracetamol 500 mg IV and diclofenac sodium intramuscularly IM to our patients postoperatively for pain management Accumulative dosages of requested NSAİ and paracetamol during the hospital stay were also recorded Patient satisfaction with the aesthetic results was assessed using a 10-point scale ranging from 1 very unsatisfied to 10 very satisfied at the 1st and 3rd months postoperatively While scoring patients were asked to score their scars by being reminded of parameters such as color stiffness thickness and irregularity All patients were blinded to which technique was used for facial closure
Statistical analysis Data were analyzed with IBM SPSS V23 IBM Corp Armonk NY USA The normality assumptions were examined with the Kolmogorov-Smirnov test Mann-Whitney U test was used to compare non-normally distributed data in pairs Wilcoxon test was used to compare non-normally distributed data within groups according to two dependent times Pearson chi-square Yates correction and Fishers Exact Test were used to examine categorical variables according to groups Data are expressed as mean standard deviation SD or median minimum-maximum as appropriate P 05 was considered statistically significant
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