Cesarean Wound Disruption With Postnatal Complication
Conditions
Keywords
cesarean section, wound complication, obesity, monocryl, vicryl, prolene, polyester
Brief summary
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.
Detailed description
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. 3\. Methodology 3.1. Study Design This study will use a prospective, randomized controlled trial design. Participants undergoing elective cesarean sections will be randomly assigned to receive subcuticular suturing with one of several suture materials.
Interventions
PROCEDUREpolyglactin 910
75 PARTICIPANT, Vicryl suture was used in subcuticular suture
PROCEDUREpoliglecaprone 25
75 PARTICIPANT, monocryl suture was used in subcuticular suture
PROCEDUREpolypropylene
75 PARTICIPANT, Prolene suture was used in subcuticular suture
PROCEDUREpolyester
75 PARTICIPANT, Polyester suture was used in subcuticular suture
Sponsors
Kafrelsheikh University
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This prospective interventional randomized comparative clinical trial was carried out on 300 pregnant women scheduled for elective caesarean section at operative theater
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women aged 20-45 years old. 2. BMI = or more than 40 kg/m2 3. Primigravida or not more than the previous 1 cesarean section. 4. Will undergo a lower-segment cesarean section. 5. Hb: ≥ 10 gm/dl. 6. Viable fetus. 7. No history of medical comorbidities.
Exclusion criteria
1. History of urogenital tract infection within 2 weeks before cesarean delivery. 2. Presence of clinical signs of infection at the time of delivery including PPROM and intraamniotic infection. 3. Medical comorbidities (hypertension, diabetes, etc.). 4. Hypersensitivity to any of the suture materials. 5. Women with abnormal placentation (placental abruption or placenta previa). 6. History of systemic corticosteroid intake during their pregnancy for 2 weeks or more. 7. History of previous surgical site infection. 8. Immune-compromised women. 9. Women refused to participate in the study or could not obtain consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of any documented wound complication during the first six weeks postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cosmetics satisfaction | 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. |
Countries
Egypt
Contacts
Primary ContactAhmed N Afifi, MD
Outcome results
None listed