Evaluation of Wound Infection Rates and Cosmetic Results of Different Suture Materials in Cesarean Skin Incision

Conditions

Cesarean Section; Infection, Scar

Keywords

suture material, Caesarean section skin scar, Pfannenstiel

Brief summary

Our primary aim is to determine the most beneficial suture in order to reduce complications due to skin incision in common surgeries such as cesarean section, and our secondary aim is to evaluate the suture material used in terms of cosmetic results and participant preference.

Detailed description

Patients who met the inclusion criteria among patients who had a cesarean delivery (January 2023-June 2023) in our hospital within a 6-month period will be included in the study. Patients included in the study will be randomized and divided into three randomized groups as Vicryl (Polyglactin 910), Monocryl (Polyglecaprone 25) and Prolene (polypropylene) to be administered. Each cesarean section technique will be left to the discretion of the surgeon performing the operation, and cefazolin 2 g will be administered prophylactically half an hour before each procedure in our clinic. In all cases, a Pfannenstiel skin incision will be made 2 cm above the pubic symphysis. Following delivery of the fetus, the uterus, peritoneum, and fascia will be closed in sequence. The skin will be sealed with Vicryl (Polyglactin 910), Monocryl (Polyglecaprone 25), and Prolene (polypropylene) according to randomization. The dressing will be removed on the first day after the operation and the patients will be discharged on the second post-op day if there is no problem after the operation. Patients will be called for control on the 10th , 60th and 120th days of pos op. If the post op 10th day is deemed appropriate, the sutures of the patients in the prolene suture group will be removed. All groups that come to the control will be evaluated with the patient and the observer doctor by the patient and observer rating scale (POSAS) and the Vancouver Scar Scale (VSS). The Patient and Observer Rating Scale (POSAS) is a questionnaire developed to assess scar quality. It consists of a five-observer and six-patient scale (Observer and Patient Scales) according to the rating scale based on clinically relevant scar characteristics \[ Draaijers LJ, 2004 , Van de Kar AL, 2005\]. Observer ; scores six items: vascularization, pigmentation, thickness, surface roughness, flexibility, and surface area. Patient ; it scores six items: pain, itching, color, thickness, relief and flexibility \[Van de Kar AL , 2005\]. All included items are scored on a multiple 10-point scale where 1 point is given when the wound feature is similar to 'normal skin' and 10 points are awarded when it reflects the 'worst scar'. All items are summed to determine the total scar score, with a higher score representing 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

Related papers

No related papers found yet.

Interventions

OTHEREvaluation of the wound infection at the 10th day post-op check-up among all groups

Discharge, redness, increased temperature, and dehiscence were accepted as wound infection.

OTHEREvaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups

The cosmetic outcome of wound site scar healing was evaluated with two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The investigator 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; A score of 1 is given when the scar characteristic is similar to 'normal skin' and a score of 10 is 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.

OTHEREvaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups

The cosmetic outcome of wound site scar healing was evaluated with two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The investigator 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; A score of 1 is given when the scar characteristic is similar to 'normal skin' and a score of 10 is 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 18-45 years old * Patients who had a primary cesarean section at our >37w hospital * Patients with a Pfannenstiel incision closed subcutaneously

Exclusion criteria

* Women <18 years and >45 years old * Those with a history of keloid * Suprapubic incision due to previous surgery * Signs of infection at or near the incision during cesarean section * Known hypersensitivity to any of the suture materials used * Having a medical condition that causes immunosuppression, such as DM, chronic corticosteroid use * Failure to obtain informed consent from the patient

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day	0-10. day	At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered 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	End of the 2nd month and 6th month	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.
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	End of the 2nd month and 6thmonth	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.
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	End of the 2nd month and 6thmonth	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.
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)	End of the 2nd month and 6th month	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.
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)	End of the 2nd month and 6th month	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.
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)	End of the 2nd month and 6th month	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.

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

Inclusion Criteria: * 18-45 years old * Patients who had a primary cesarean section at 37w * Patients with a Pfannenstiel incision closed subcutaneously

Participants by arm

Arm	Count
Group 1 (Vicryl Suture™(Polyglactin 910)) 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.	100
Group 2 (Prolene Suture™(Polypropylene)) 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.	100
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. 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.	100
Total	300

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	15	13	21

Baseline characteristics

Characteristic	Group 1 (Vicryl Suture™(Polyglactin 910))	Group 2 (Prolene Suture™(Polypropylene))	Group 3 (Monocryl Suture™ (Polyglecaprone 25))	Total
Age, Continuous	28.5 years STANDARD_DEVIATION 5.8	27.3 years STANDARD_DEVIATION 5.6	27.9 years STANDARD_DEVIATION 5.7	27.9 years STANDARD_DEVIATION 6.4
BMI	29.2 kg/m² STANDARD_DEVIATION 5.5	30.8 kg/m² STANDARD_DEVIATION 5.1	30.4 kg/m² STANDARD_DEVIATION 4.8	30.1 kg/m² STANDARD_DEVIATION 5.8
Race and Ethnicity Not Collected	—	—	—	0 Participants
Sex: Female, Male Female	100 Participants	100 Participants	100 Participants	300 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 85	0 / 87	0 / 79
other Total, other adverse events	12 / 85	5 / 87	2 / 79
serious Total, serious adverse events	0 / 85	0 / 87	0 / 79

Outcome results

Primary

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

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.

Time frame: End of the 2nd month and 6th month