An interventional study of polyglactin 910 and poliglecaprone 25 in Cesarean Wound Disruption With Postnatal Complication, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
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.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 300 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
- Group A: (75) women with subcuticular suture polyglactin 910, braided, (VICRYL RAPIDE®; Ethicon) was used in subcuticular skin closure.
Procedure: polyglactin 910
Group A: (75) women with subcuticular suture poliglecaprone 25, (MONOCRYL) was used in subcuticular skin closure.
Procedure: poliglecaprone 25
Group A: (75) women with subcuticular suture polypropylene, (PROLENE) was used in subcuticular skin closure.
Procedure: polypropylene
Group A: (75) women with subcuticular suture POLYESTER, (ETHIBOND EXCEL Suture) was used in subcuticular skin closure.
Procedure: polyester
75 PARTICIPANT, Vicryl suture was used in subcuticular suture
Also known as: VICRYL
75 PARTICIPANT, monocryl suture was used in subcuticular suture
Also known as: monocryl
75 PARTICIPANT, Prolene suture was used in subcuticular suture
Also known as: prolene
75 PARTICIPANT, Polyester suture was used in subcuticular suture
Also known as: ETHIBOND EXCEL Suture
the rate of any documented wound complication during the first six weeks postpartum
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
cosmetics satisfaction
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.
Time frame: 6 weeks
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Cairo University