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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)

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

7

The mean age was 62.4 years (range: 47-83). Five patients were male, and 2 patinets were female. The mean longest diameter was 12.1 cm (range: 9-15), and the mean size was 94.5 cm2 (range: 63.6-164.9). Defects of all the cases were caused by resection of malignant skin tumors. 5 cases were diagnosed as dermatofibrosarcoma protuberance, 1 case was diagnosed as malgnant fibrous histiocytoma and 1 case was diagnosed as breast cancer or cutaneous apocrine carcinoma. All the cases showed defects with muscle exposure.

Since the number of registered cases was smaller than expected, we had the registration period extended for one year. However, the registered cases were 7, although the number of planned cases was 8. All of the 7 cases have completed the study, and none of them have canceled or dropped out of the sudy.

Case 1: wound pain (grade 1) Case 2: wound pain (grade 1), back pain (grade 1), fever (grade 1) Case 3: wound pain (grade 1), diarrhea (grade 1) Case 4: wound pain (grade 1), eczema in the neck (grade 1) Case 5: wound pain (grade 1), constipation (grade 1), anal pain (grade 1), ruptured suture of the grafts (grade 1). Case 6: wound pain (grade 1), increased transaminase (grade 1), anemia (grade 1) Case 7: wound pain (grade 1) Any of the adverse events were not associated with the negative pressure closure system, and all the cases recovered from the adverse events.

The primary endopoint was safety in the negative pressure closure system for skin graft stabilization. In the registered 7 cases, all the cases showed grade 1 adverse envents, but any of the adverse events were not associated with the negative pressure closure system. As for the secondary endopoint, the mean survival rate 7 days after operation was 98.7% (range: 97-100) and the mean survival rate 10 days after operation was 96.5% (range: 89.4-98.4). The mean number of days from operation to discharge was 12.7 days (range: 11-17). The mean survival of the skin graft at discharge was 95.6% (range: 85.5-99.2). 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). The mean time from harvesting skin graft until the end of the graft stabilization was 15.6 minutes (range:11.5-27).

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.

Mar. 31, 2023

No

n/a

https://jrct.mhlw.go.jp/latest-detail/jRCTs032180062

Nakamura Yoshiyuki

University of Tsukuba

2-1-1, Amakubo, Ibaraki

ynakamura-tuk@umin.ac.jp

Nakamura Yoshiyuki

University of Tsukuba

2-1-1, Amakubo, Ibaraki

+81-29-853-3128

ynakamura-tuk@umin.ac.jp

Complete

Nov. 01, 2018

Interventional

single arm study

open(masking not used)

uncontrolled control

factorial assignment

treatment purpose

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

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.

Both

Skin defect

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

Skin defect, skin graft

Skin graft, negative pressure closure

Safety

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

+81-29-853-3914

Oct. 30, 2018

Japan