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

Phase 2

• Conditions: Skin defect; Skin defect, skin graft

• Registration Number: JPRN-jRCTs032180062
• Lead Sponsor: akamura Yoshiyuki

Brief Summary

In this study, there were no cases with adverse events associated with the negative pressure closure system. The mean survival rate of the skin graft 7 and 10 days after operation was 98.7% (range: 97-100) and 96.5% (range: 89.4-98.4), respectively. The mean time from initiatoin of the skin graft stabilization to the end of the operation was 12.9 minutes (range: 10.7-19.5), suggesting safety and usefulness of negative pressure closure system for graft stabilization.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-25
• Study Completion: 2020-05-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Patients with defects in the trunk and extremities of >10 cm in size, or with muscle exposure.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
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