The Production Of Negative Pressure Text-aid And Preliminary Clinical Application

ObjectiveWe try to find out the design method of wound glue of negative pressure, and manufacture the samples. Through detection of the samples, make product standards,providing basis for future product standards register and clinical verification test.Contents and methods1.The idea of negative pressure wound glue came from the cut\the surface of wound of constant negative pressure device (patent number: ZL200810143868.1), and consummate the design based on this patent,confirm the drawings of mold of the product.2. Materials selection of negative pressure wound glue:the main materials made by medical silica,sticking colloid around the wound skin use3M medical double-sided adhesive.3. The disinfection method of the wound glue of negative pressure use radiation disinfection.4. The sample tests of negative pressure wound glue include: character, size, the value of negative pressure, pH value, heat resistance test, cold test and skin stimulation test. Confirm and regulate the production of negative pressure wound glue process through these tests, then set its preliminary registered production standard and its product service instruction.5. Make clinical verification scheme:the project content and purpose of clinical verification, overall design and clinical evaluation standard, last time of clinical trials and its reason, clinical trial case number and its reason, the scope of object selection, object quantity and its reason,clinical performance evaluation method and statistics processing method, side effects prediction and measures should take.6. Preliminary clinical application cases:choose3patients, contrast wound healing condition before and after the treatment.Results1. Through the detection of the wound glue, proved the production performance safety is high and it can easily control the negative pressure.2. Made registered production standards and passed the test of Hunan Medical Instruments and Pharmaceutical Packaging Materials (containers) Detection Institute.3. Established clinical verification scheme and applied by preliminary clinical. From comparison of pictures of the3selected patients,the negative pressure wound plue could accelerate wound healing, obtained obvious clinical therapy effect.ConclusionThis experimental subject successively designed the negative pressure wound glue,and it is a portable wound negative pressure treatment device. It can accelerate wound healing, and can substitute large negative pressure device and daily treatment of changing fresh dressing for a wound.