The study of the process on healing of uterine cesarean section wound with using different threads.

JRCT ID: jRCT1052230068

Registered date:15/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Suture Techniques
• Date of first enrollment: 15/07/2023
• Target sample size: 60
• Study type: Interventional

Intervention(s)

For cesarean section, one of the following threads will be used to suture the uterine wall, with no other intervention for any other treatment or procedure.
Group A : sutures with barbed sutures
Group B : sutures without barbs

Outcome(s)

Primary Outcome

Evaluate the incisional wound 6 months (+3 months allowed) after cesarean section.
Depth of depressed scar (mm)

Secondary Outcome

Postoperative complications (infection, bowel obstruction, thrombosis, postpartum hemorrhage, irregular genital bleeding, menstrual abnormalities)
Surgical findings with different sutures (operation time, amount of blood loss, number of additional sutures performed to stop bleeding in the wound)
Blood laboratory findings (blood count, CRP, fibrinogen, FDP, D-dimer, AST, ALT, BUN, Cre, UA, LDH) on admission and on postoperative days 1 and 3
Characteristics of the cesarean scar (Healing ratio = thickness of thinned muscle layer (mm)/thickness of normal muscle layer (mm), location of the wound (distance from the deepest endometrium to the wound and distance from the wound to the external opening of the uterus))

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) over 20 years old
2) over 37 gestational week
3) first cesarean section

Exclude criteria

1) multiple pregnancy
2) those deemed inappropriate as research subjects by the principal investigator or subinvestigator
3) persons who are sensitized to triclosan or allergic to metals

Related Information

• Primary Sponsor: Tachibana Daisuke