Study on surgical drain fixation methods

JRCT ID: jRCT1042220089

Registered date:07/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: All diseases for which drains are placed
• Date of first enrollment: 07/11/2022
• Target sample size: 50
• Study type: Interventional

Intervention(s)

In the drain fixation group, the drain is sutured directly to the skin with 4-0 nylon suture.
In the group with suture fixation to the covering material, the drain is sutured to Mepilex Border Post-Op with 4-0 nylon suture, and Mepilex Border Post-Op is applied to the skin.

Outcome(s)

• Primary Outcome: Evaluation of cosmetic appearance using the Vancouver Scar Scale by a plastic surgeon at the first postoperative month

Secondary Outcome

Evaluation of cosmetic appearance using the Vancouver Scar Scale by a plastic surgeon
Evaluation of cosmetic appearance and pain using Patient and Observer Scar Assessment Scale by patients
Incidence of accidental removal of drain
Rate of complications such as drain remobilization
Time from surgery to drain removal

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: This study will be open to all patients with diseases for which a drain is inserted at the Department of Pediatric Surgery, Nagoya University Hospital. Patients or their family members have the ability to consent to participate in this study and are able to participate in this study until the follow-up after six months.
• Exclude criteria: Patients undergoing reoperation, patients with underlying diseases such as immunodeficiency, diabetes, chronic renal failure, malnutrition, keloid constitution, or multiple drains placed at the same time

Related Information

• Primary Sponsor: Shirota Shirota