Evaluation of the effectiveness and safety of closed negative pressure drainage nursing system (PU suction cup type): a perspective, randomized, open, parallel controlled and non-inferiority trial

doi:10.3969/j.issn.2095-4344.1990

Abstract

Abstract:

BACKGROUND: The closed negative pressure drainage nursing system (PU suction cup type) is a wound treatment device with continuous closed negative pressure drainage function developed on the basis of vacuum sealing drainage in recent years. Under the premise of correct use and effective drainage, it is convenient for medical personnel to monitor wound healing in real time compared with traditional dressing debridement, which can obviously reduce the application of large doses of antibacterial drugs and the number of dressing changes, thereby reducing treatment costs, shortening hospitalization time, and alleviating patient suffering.
OBJECTIVE: To evaluate the clinical efficacy and safety of the closed-type negative pressure drainage nursing system (PU suction cup type), and to provide theoretical and data support for its clinical promotion and product application registration.
METHODS: Totally 132 patients needing vacuum sealing drainage were randomly divided into trial group (closed suction drainage system record (PU suction type) and control group (the use of closed suction drainage kit (II-PU type)) (n=66/group). The therapeutic effect within 14 days was evaluated. The primary measurement outcome was the efficacy with 14 days. The secondary measurement outcomes were Visual Analog Scale score, operating satisfaction, physical properties, and safety evaluation indexes: incidence of adverse events/reactions, incidence of complications, and laboratory examination indexes.
RESULTS AND CONCLUSION: (1) Effectiveness index: the effective rate of both groups was 100% within 14 days of treatment. Compared with before treatment, the Visual Analog Scale scores in the two groups were significantly decreased after treatment of (10±3) days (P < 0.05), and there was no significant difference between two groups. (2) Safety indicators: There were no significant differences in laboratory test indicators (blood routine, liver function, coagulation) before and after treatment. The two groups of product operation satisfaction, product physical properties could meet 100% of clinical use. No complications occurred in both groups. During the whole trial period, 9 (13.6%) of the 66 subjects in the trial group appeared with adverse events, and 10 (15.2%) of the 66 subjects in the control group had adverse events. (3) These results imply that the efficacy and safety of the closed negative pressure drainage material set (PU) for wound drainage are comparable to that of the control product, which is worthy of clinical promotion. The trial has been approved by the Ethical Committee of Tangdu Hospital of Air Force Medical University on September 13, 2016, approval No. 201609-10.

Key words: closed suction drainage nursing record material , skin, trauma wounds, wound healing, effectiveness, safety, evaluation indexes

CLC Number:

Yuan Yacui1, Liu Linna2, Liu Xiwen3, Li Yuejun1, Zhao Congying1, Han Lin1. Evaluation of the effectiveness and safety of closed negative pressure drainage nursing system (PU suction cup type): a perspective, randomized, open, parallel controlled and non-inferiority trial [J]. Chinese Journal of Tissue Engineering Research, 2019, 23(35): 5676-5681.

Figures/Tables 5

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