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

A specified clinical study for safety and usefulness of negative pressure closure for the stabilization of skin graft in wide or muscle-exposing defects - NPSG study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032180062
Enrollment
8
Registered
2018-12-25
Start date
2019-08-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin defect Skin defect, skin graft

Interventions

Skin grafts are fixed by negative pressure closure with RENASYS (Smith & Nephew).
Skin graft, negative pressure closure

Sponsors

Nakamura Yoshiyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
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

Contacts

Public ContactYoshiyuki Nakamura

University of Tsukuba

ynakamura-tuk@umin.ac.jp+81-29-853-3128

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026