Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06303817 |
| Other study ID # |
1812 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Adana City Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 (e.g., 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 and/or
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 surgeon's
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.
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: 1812/2022), 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 0.50 (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 (e.g., 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 1:1
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 and/or 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 surgeon's 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 Fisher's 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.
