Efficacy of a Disposable Skin-Stretch Closure Device Combined With Vacuum Sealing Drainage in the Treatment of Refractory Skin and Soft Tissue Defects: A Single-Arm Prospective Study.

OBJECTIVES

The treatment of refractory skin and soft tissue defects (RSSTDs) has long posed a global challenge for surgeons. Traditional closure methods, such as skin grafting and flap repair, are often associated with significant trauma and a steep learning curve. Skin stretching, which enables the generation of "extra skin," has emerged as a promising alternative. This study aims to evaluate the efficacy of a disposable skin-stretch closure (DSSC) device combined with vacuum sealing drainage (VSD) in the treatment of RSSTDs.

METHODS

A prospective single-arm clinical study was conducted to analyze the clinical data of 43 patients with RSSTDs who were treated with the DSSC device for wound repair at our hospital between July 2022 and December 2024. Among these patients, 30 were male and 13 were female, with ages ranging from 14 to 71 years (mean: 41.86 ± 16.02 years). The wound areas ranged from 4 to 90 cm2 (mean: 18.56 ± 18.04 cm2). Wound conditions (including closure and healing) and the presence of complications were recorded. Wound closure was defined as the approximation of wound edges by manually compressing the bilateral skin to achieve tension-free or minimal-tension coaptation, allowing direct suturing. Closure time and closure rate (wound area/closure time) were recorded. Wound healing was defined as 100% re-epithelialization of the wound surface, confirmed during two consecutive follow-up assessments spaced 2 weeks apart, with no exudate, drainage, or dressing requirements. Healing time and healing grade (classified as Grade A, B, or C according to wound healing classification standards) were recorded.

RESULTS

All 43 patients were followed up, and all wounds achieved primary healing. No complications, including wound edge damage, necrosis, infection, dehiscence, or edema, were reported. Patients did not report pain or discomfort, and no significant scar formation was observed during the follow-up. The wound closure time ranged from 5 to 17 days (mean: 9.07 ± 2.93 days), which was comparable to the 7.8 ± 3.8 days reported in the literature. The wound closure rate ranged from 0.35 to 7.44 cm2/day (mean: 1.99 ± 1.63 cm2/day). The wound healing time ranged from 17 to 29 days (mean: 22.74 ± 2.80 days). The Visual Analog Scalescores ranged from 1 to 3 (mean: 2.02 ± 0.64), significantly lower than the 7.0 ± 1.0 reported in the literature. One patient experienced complete wound healing within 17 days without the need for suturing.

CONCLUSION

The DSSC device was effective in treating RSSTDs, with short wound closure times, minimal complications, and a simple procedure.