A prospective, phase II study on the safety and efficacy of negative pressure closure for the stabilization of split‐thickness skin graft in large or muscle‐exposing defects: The NPSG study

Abstract

Several studies have demonstrated the usefulness of negative pressure closure (NPC) for the stabilization of skin grafts because it provides a uniform pressure to the graft.The results of our previous retrospective study also suggested the superiority of NPC over tie-over methods for the stabilization of split-thickness skin graft (STSG) in large or muscle-exposing defects. However, the usefulness of NPC for graft stabilization is yet to be fully established. This prospective, phase II clinical study was conducted to investigate the safety and efficacy of NPC for the stabilization of STSG in large or muscle-exposing defects. Patients who would require STSG for reconstruction of defects in the trunk and extremities other than hands and feet measuring >10 cm in the longest diameter or with muscle exposure were enrolled. NPC was applied for skin graft stabilization. Seven patients who had received wide excision of malignant tumors and resulted in muscleexposed skin defects were included. All patients underwent meshed STSG. The mean size of the defect was 94.5 cm 2 (range 63.6-164.9). The mean time from the skin graft harvesting to the NPC stabilization was 15.6 min (range 10.7-19.5). The mean survival rate of the skin graft at postoperative day 7 and 10 was 98.7% (range 97-100) and 96.5% (range 89.4-98.4), respectively. No adverse events associated with the procedure were observed. This prospective study provided further evidence of the safety and efficacy of NPC for STSG stabilization in patients with large or muscle-exposing skin defects.

Statistical Study on Negative Pressure Strength during Skin Graft Fixation

“…Ito et al 9) reported cases of over-compression even at 100 mmHg and recommended that 50-75 mmHg was appropriate for skin graft fixation. A prospective study on skin graft fixation in STSG by Nakayama et al 10) reported that 50 mmHg might be suitable to prevent adverse effects, such as pain while using the NPWT device. Others have reported that approximately 50 mmHg is sufficient 11) , while 100-125 mmHg is recommended with an emphasis on fixed stability 12) .…”

“…Conversely, the strength of negative pressure during fixation has been mentioned in several studies [9][10][11][12] , but none is currently based on a high level of evidence. Therefore, in actual practice, the setting of negative pressure strength is at the clinician's discretion.…”

Combination of Three Different Negative Pressure Wound Therapy Applications and Free Flap for Open Elbow Joint Injury With Extensive Burns

“…5 The use of NPWT for skin graft fixation is advantageous because it provides uniform pressure to the skin graft even when there are large defects or moving parts. 13 There are also reports that the use of NPWT eliminates the need for splints for skin grafts involving the joints of the upper limbs. 14 Reports on suction pressure range from −25 to −125 mm Hg.…”

Evidence from Clinical Studies Related to Dermatologic Surgeries for Skin Cancer

“…In addition, NPC showed a tendency toward a shorter time from the harvesting of the skin graft to the end of the NPC graft stabilization than that of the tie-over method. Then, we also conducted a prospective, phase-II clinical study to investigate the safety and efficacy of NPC for the stabilization of STSG in large (longest diameter, >10 cm) or muscle-exposing defects [ 147 ]. In that study, the mean survival rate of the skin graft was higher than 95% at day 10, and the mean time from harvesting of the skin graft to the end of NPC graft stabilization was shorter than 20 min, suggesting that NPC for stabilization of STSG leads not only to a high survival rate of the skin graft but also to a short operative time.…”