Trial Outcomes & Findings for Evaluation of Wound Infection Rates and Cosmetic Results of Different Suture Materials in Cesarean Skin Incision (NCT NCT06119113)
NCT ID: NCT06119113
Last Updated: 2025-12-18
Results Overview
At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered as wound infection.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
0-10. day
Results posted on
2025-12-18
Participant Flow
Inclusion Criteria: * 18-45 years old * Patients who had a primary cesarean section at 37w * Patients with a Pfannenstiel incision closed subcutaneously
Participant milestones
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
The group whose skin incision is closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection.Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 2 (Prolene Suture™(Polypropylene))
The group whose skin incision is closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group whose skin incision is closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
Post op 10th Day Check-up
|
92
|
95
|
96
|
|
Overall Study
Post op 2nd Month Check-up
|
85
|
87
|
79
|
|
Overall Study
Post op 6st Month Check-up
|
85
|
87
|
79
|
|
Overall Study
COMPLETED
|
85
|
87
|
79
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
21
|
Reasons for withdrawal
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
The group whose skin incision is closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection.Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 2 (Prolene Suture™(Polypropylene))
The group whose skin incision is closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group whose skin incision is closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
13
|
21
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=100 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 2 (Prolene Suture™(Polypropylene))
n=100 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
n=100 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 5.8 • n=100 Participants
|
27.3 years
STANDARD_DEVIATION 5.6 • n=100 Participants
|
27.9 years
STANDARD_DEVIATION 5.7 • n=100 Participants
|
27.9 years
STANDARD_DEVIATION 6.4 • n=300 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
300 Participants
n=300 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=300 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
29.2 kg/m²
STANDARD_DEVIATION 5.5 • n=100 Participants
|
30.8 kg/m²
STANDARD_DEVIATION 5.1 • n=100 Participants
|
30.4 kg/m²
STANDARD_DEVIATION 4.8 • n=100 Participants
|
30.1 kg/m²
STANDARD_DEVIATION 5.8 • n=300 Participants
|
PRIMARY outcome
Timeframe: 0-10. dayPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered as wound infection.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=92 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 2 (Prolene Suture™(Polypropylene))
n=95 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
n=96 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
|---|---|---|---|
|
Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day
Wound infection
|
12 Participants
|
5 Participants
|
3 Participants
|
|
Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day
No wound infection
|
80 Participants
|
90 Participants
|
93 Participants
|
PRIMARY outcome
Timeframe: End of the 2nd month and 6th monthPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=85 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 2 (Prolene Suture™(Polypropylene))
n=87 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
|---|---|---|---|
|
Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 2 (Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
POSAS 6th month evaluatıon
|
20.9 units on a scale
Standard Deviation 6.1
|
16.5 units on a scale
Standard Deviation 3.9
|
—
|
|
Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 2 (Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
POSAS 2nd month evaluation
|
26.9 units on a scale
Standard Deviation 8.9
|
20.5 units on a scale
Standard Deviation 5.1
|
—
|
PRIMARY outcome
Timeframe: End of the 2nd month and 6thmonthPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=85 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 2 (Prolene Suture™(Polypropylene))
n=79 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
|---|---|---|---|
|
Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
POSAS 2nd month evaluatıon
|
26.9 units on a scale
Standard Deviation 8.9
|
18.7 units on a scale
Standard Deviation 3.9
|
—
|
|
Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
POSAS 6th month evaluatıon
|
20.9 units on a scale
Standard Deviation 6.1
|
14.5 units on a scale
Standard Deviation 2.4
|
—
|
PRIMARY outcome
Timeframe: End of the 2nd month and 6thmonthPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=86 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 2 (Prolene Suture™(Polypropylene))
n=79 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
|---|---|---|---|
|
Comparison of Incision Cosmetic Results Between Group 2 (Prolene Suture™(Polypropylene)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
POSAS 2nd month evaluatıon
|
20.5 units on a scale
Standard Deviation 5.1
|
18.7 units on a scale
Standard Deviation 3.9
|
—
|
|
Comparison of Incision Cosmetic Results Between Group 2 (Prolene Suture™(Polypropylene)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS
POSAS 6sh month evaluatıon
|
16.5 units on a scale
Standard Deviation 3.9
|
14.5 units on a scale
Standard Deviation 2.4
|
—
|
PRIMARY outcome
Timeframe: End of the 2nd month and 6th monthPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=85 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 2 (Prolene Suture™(Polypropylene))
n=87 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
|---|---|---|---|
|
Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 2(Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale (VSS)
VSS 6th month evaluatıon
|
3 units on a scale
Interval 1.0 to 6.0
|
3 units on a scale
Interval 1.0 to 6.0
|
—
|
|
Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 2(Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale (VSS)
VSS 2nd month evaluatıon
|
4 units on a scale
Interval 1.0 to 8.0
|
3 units on a scale
Interval 1.0 to 5.0
|
—
|
PRIMARY outcome
Timeframe: End of the 2nd month and 6th monthPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=85 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 2 (Prolene Suture™(Polypropylene))
n=79 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
|
|---|---|---|---|
|
Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS)
VSS 2nd month evaluatıon
|
4 units on a scale
Interval 1.0 to 8.0
|
3 units on a scale
Interval 1.0 to 6.0
|
—
|
|
Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS)
VSS 6th month evaluatıon
|
3 units on a scale
Interval 1.0 to 6.0
|
2 units on a scale
Interval 1.0 to 4.0
|
—
|
PRIMARY outcome
Timeframe: End of the 2nd month and 6th monthPopulation: Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously
The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound.
Outcome measures
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=86 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
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Group 2 (Prolene Suture™(Polypropylene))
n=79 Participants
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
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Group 3 (Monocryl Suture™ (Polyglecaprone 25))
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection.
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|---|---|---|---|
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Comparison of Incision Cosmetic Results Between Group 2(Prolene Suture™(Polypropylene)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS)
VSS 2nd month evaluatıon
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3 units on a scale
Interval 1.0 to 5.0
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3 units on a scale
Interval 1.0 to 6.0
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—
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Comparison of Incision Cosmetic Results Between Group 2(Prolene Suture™(Polypropylene)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS)
VSS 6th month evaluatıon
|
3 units on a scale
Interval 1.0 to 6.0
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2 units on a scale
Interval 1.0 to 4.0
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—
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Adverse Events
Group 1 (Vicryl Suture™(Polyglactin 910))
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2 (Prolene Suture™(Polypropylene))
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Vicryl Suture™(Polyglactin 910))
n=85 participants at risk
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
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Group 2 (Prolene Suture™(Polypropylene))
n=87 participants at risk
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
|
Group 3 (Monocryl Suture™ (Polyglecaprone 25))
n=79 participants at risk
The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin.
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|---|---|---|---|
|
Skin and subcutaneous tissue disorders
dehiscence and discharge
|
12.9%
11/85 • 6 months
Other (Not Including Serious) Adverse Events
|
4.6%
4/87 • 6 months
Other (Not Including Serious) Adverse Events
|
2.5%
2/79 • 6 months
Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Apse
|
1.2%
1/85 • 6 months
Other (Not Including Serious) Adverse Events
|
0.00%
0/87 • 6 months
Other (Not Including Serious) Adverse Events
|
0.00%
0/79 • 6 months
Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
Hematom
|
0.00%
0/85 • 6 months
Other (Not Including Serious) Adverse Events
|
1.1%
1/87 • 6 months
Other (Not Including Serious) Adverse Events
|
0.00%
0/79 • 6 months
Other (Not Including Serious) Adverse Events
|
Additional Information
Dr.Ayşenur Çalış Özbayram
Başakşehir Çam Ve Sakura Şehir Hastanesi
Phone: +905549707052
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place