faculty of medicine, Kasr el ainy hospital, Cairo university
Cairo, 11562, Egypt
NCT Number: NCT06543329
1.1. Background and Rationale Cesarean section is one of the most common surgical procedures performed worldwide. The choice of suture material for closing the skin incision is crucial, as it can influence wound healing, the risk of wound complications, and the cosmetic outcome. Subcuticular suturing, a technique where the suture is placed just under the skin, is favored for its aesthetic benefits and reduced risk of infection. However, the type of suture material used can significantly impact these outcomes. This study aims to provide a comparative analysis of various subcuticular suture materials used in cesarean sections, focusing on wound complications and incision outcomes.
1.2. Objective of the Study The objective of this study is to compare the incidence of wound complications and the quality of incision outcomes associated with different subcuticular suture materials used in cesarean sections. By doing so, the investigators aim to identify the most effective suture material for minimizing wound complications and optimizing cosmetic results.
Trial opening soon.
Get Notified20 year–45 year
Female
Interventional
Not applicable
Cairo, 11562, Egypt
2.1. Surgical Techniques in Cesarean Section Cesarean section involves multiple surgical steps, including skin incision, uterine incision, and closure of the incisions. The subcuticular suturing technique is often preferred for skin closure due to its potential for better cosmetic results and lower infection rates compared to other methods like staples or interrupted sutures.
2.2. Types of Suture Materials
Suture materials can be broadly categorized into absorbable and non-absorbable, and further into monofilament and multifilament types. Common suture materials used in subcuticular skin closure include:
Absorbable Sutures: Poliglecaprone (Monocryl), Polyglactin (Vicryl), Polydioxanone (PDS).
Non-Absorbable Sutures: Nylon, Polypropylene (Prolene), Silk. 2.3. Previous Studies on Suture Materials in Cesarean Section Previous studies have explored the impact of different suture materials on wound healing, infection rates, and cosmetic outcomes. Research indicates varying results, with some studies favoring absorbable sutures for their reduced need for removal and lower infection rates, while others suggest non-absorbable sutures may provide stronger wound support. However, comprehensive comparative analyses specific to cesarean sections remain limited.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
75 PARTICIPANT, Vicryl suture was used in subcuticular suture
Other names: VICRYL
75 PARTICIPANT, monocryl suture was used in subcuticular suture
Other names: monocryl
75 PARTICIPANT, Prolene suture was used in subcuticular suture
Other names: prolene
75 PARTICIPANT, Polyester suture was used in subcuticular suture
Other names: ETHIBOND EXCEL Suture
Time frame: 6 weeks
This measure tracks the incidence of wound complications within six weeks postpartum, including infection, dehiscence, seroma, hematoma, ecchymosis, pus, delayed healing, and secondary suture needs.
Measurement Tools:
Clinical examinations during follow-up visits Patient self-reports Review of medical records
Assessment Procedure:
Patients will undergo follow-up visits at 2, 4, and 6 weeks postpartum. Complications will be documented through clinical exams, patient reports, and medical record reviews.
Calculation:
The rate is calculated as the number of patients with any wound complication divided by the total number of patients, expressed as a percentage.
Time frame: 6 weeks
This measure assesses the cosmetic appearance of surgical wounds post-abdominal myomectomy.
Measurement Tool:
A standardized cosmetic appearance scale will be used, such as the Patient and Observer Scar Assessment Scale (POSAS).
Assessment Procedure:
Evaluations will be conducted at follow-up visits (2, 4, and 6 weeks postpartum) by both the patient and a clinician.
Parameters Assessed:
Scar color, texture, and overall appearance Patient satisfaction with the cosmetic outcome
Calculation:
Scores from the POSAS will be averaged to determine the overall cosmetic appearance rating.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Comparative Analysis Between Different Suture Materials in Subcuticular Cesarean Wound Closure in Woman With BMI 40 or Greater in Cesarean Delivery: An Interventional Randomized Comparative Clinical Trial
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