Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543329
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-27
Brief Title:
Comparative Analysis of Subcuticular Suture Materials in Cesarean Section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
11 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
12 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
12 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:
21 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
22 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 23 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 31 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
22 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 23 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 31 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None