Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119113
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-09-27
Brief Title:
Wound Infection Due to Suture Material in Caesarean Skin Incision and Evaluation of Cosmetic Results
Sponsor:
Ayşenur Çalış Özbayram
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Evaluation of Wound Site Infection Early and Late Wound Healing and Cosmetic Results of Vicryl Tekmon and Prolene Suture Materials Used in Pfannenstiel Skin Incision in Caesarean Section Surgery
Status:
COMPLETED
Status Verified Date:
2023-11
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:
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
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
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