A specified clinical study for negative pressure closure for the stabilization of skin graft

JRCT ID: jRCTs032180062

Registered date:25/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Skin defect
• Date of first enrollment: 13/08/2019
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Skin grafts are fixed by negative pressure closure with RENASYS (Smith & Nephew).

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Graft survival 7 and 10 after surgery, time between starting the graft stabilization and the end of the operation, and time between surgery and hospital discharge

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with defects in the trunk and extremities of >10 cm in size, or with muscle exposure.
• Exclude criteria: Defects with contraindication for negative pressure closure (defects with exposure of main vessels, organs or nerves. Defects with fissures connected with organs or untested fissures. Defects with liquorrhea or digestive system fistula, which are suspected to become severer by negative pressure closure. Defects with necrosis, osteomyelitis with osteonecrosis or apparent malignant tumor.) Dialysis patients, diabetic patients (HbA1c>8%), patients with systemic steroid therapies (>prednisolone 20mg/ day). Defects of which the fixation by negative pressure closure is difficult because of hubby surface of surrounding tissues. Defect with bone exposure. Cases in which the devices are possible to be broken because of difficulty of keeping the patient at rest. A patient who shows more than 2 skin defects that fit the inclusion criteria.

Related Information

• Primary Sponsor: Nakamura Yoshiyuki