â??A 12 week, prospective, open-label, randomized controlled clinical trial, comparing indigenized Negative Pressure Device (NPD) to standard wound care for the treatment of bedsores in traumatic paraplegia patients. - NPWT (Negative pressure wound therapy)

Council of Science Technology0 个研究点目标入组 54 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Sacral pressure sores in traumatic paraplegia patients with no signs of improvement and healing.
•2.Stage III-IV pressure ulcer according to the National Pressure Ulcer Advisory Panel (NPUAP)
•3.No clinical signs of active infection at the wound site and currently not on antibiotics.
•4. Patients to give informed consent.

•1.Candidate for surgery.
•2.A wound with necrotic tissue unable to tolerate debridement.
•3.Exposed blood vessels within the wound.
•4.Chronic osteomyelitis (as determined by biopsy) or osteomyelitis that is not treatable by debridement and antibiotics.
•5.Non-enteric or unexplored fistulae.
•6.Wounds requiring homeostasis (i.e., that the flow of blood be stopped) for local bleeding.
•7.Alternate etiology for non-healing.
•8.Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study (e.g., malignancy in wound, malignancy less than 1-year disease free interval, previous or current irradiation, known immunodeficiency and/or major uncorrected medical disorders such as serious non-malignant disease, serious cardiovascular or pulmonary disease, lupus, inflammatory bowel disease, palliative care or sickle cell disease)
•9.Poor nutritional status as determined by a Braden Scale Nutritional Assessment score of 2 or 1 with a serum albumin < 2.5 g/L and hemoglobin < 9.0 g/L.
•10.Currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion)
•11.Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control

发起方

Council of Science Technology