A multicenter interventional study on the efficacy and safety of continuous absorbable barbed sutures in rectus abdominis muscle fascia closure technique during free abdominal flap harvesting.

JRCT ID: jRCT1052230095

Registered date:04/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing reconstructive surgery with free abdominal flap transfer
• Date of first enrollment: 04/09/2023
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Hybrid method, combination of continuous and single interrupted sutures for rectus abdominis fascial closure is performed in this study. For the continuous suture, an absorbable barbed surture (product name: STRATAFIXSymmetric PDS Plus(Johnson & Johnson Co., Ltd., Tokyo) is used. For single interrupted sutures, 2-0 Neoblade(Alfaressa Pharma, Osaka) or 2-0 nylon blade (Akiyama Seisakusho Co., Ltd., Tokyo) is used.

Outcome(s)

• Primary Outcome: Presence or absence of hernia or bulge up to 180 days after surgery

Secondary Outcome

Presence or absence of bulges up to 90 days after surgery
Presence or absence of bulges up to 180 days after surgery
Presence or absence of hernia up to 90 days after surgery
Presence or absence of hernia up to 180 days after surgery
Time required for fascial closure
Hernia/bulge-free period
Presence or absence of complication

Key inclusion & exclusion criteria

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

Include criteria

1. Patients aged 20 years or older at the time of informed consent
2. Patients who plan to undergo reconstruction using a free abdominal flap (regardless of reconstruction site) within the target period
3. Patients who received an explanation of this study from the attending doctor before surgery and obtained written consent to participate
4. Patients expected to survive for 180 days or more after surgery

Exclude criteria

Patients who meet any one of the following criteria are excluded from the study.
1. Patients with incisional hernia before surgery
2. Patients who have undergone abdominal flap surgery in the past
3. Patients who have difficulty standing on their own or with assistance, making it impossible to determine hernia or bulge
4. Patients taking oral steroids
5.Patients with sensitization or metal allergy to triclosan
6.Patients judged to be inappropriate by the doctor in charge of this clinical study

Related Information

• Primary Sponsor: Nomura Tadashi