A Prospective, Open, Randomised Controlled Trial to Compare OPSITE Post-Op Visible Wound Dressings With Standard Therapy in the Treatment of Surgical Incisions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Average wear time per patient
研究概览
简要总结
OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive. The comparator is a standard care treatment regime comprising tape and gauze.
This study requires 100 eligible patients which will be recruited from the patients routinely see by the study investigators at each study site. Eligible patients will undergo surgery that results in a surgical wound of 27cm or less that is expected to have low or moderate levels of exudate and will have received at least one randomised study treatment. The primary objective is to compare OPOV and tape/gauze in terms of wear time per patient.
详细描述
OPSITE Post-Op Visible (OPOV) is a post-operative dressing that has been developed to protect the wound from bacteria in the environment and absorb blood or other fluid exuding from the wound. The honeycomb nature of the dressing pad allows direct visibility of the wound through the dressing, minimising the need to expose the wound to the environment and the patient to the trauma of a dressing change just for the clinician to inspect the wound. OPOV is unique in combining these features and offers a real benefit over other standard post-operative dressing regimes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing "clean surgery" in an operating room
- •Patients whose wounds will be closed surgically and not left to heal by secondary intention.
- •Patients who are in-patients and are expected to be so for at least 5 days or are willing to return to the site for dressing changes.
- •Patients who are at least 18 years of age.Patients who understand the trial and are willing to consent to the trial
- •Patients who are willing to attend the post-discharge follow-up assessment.
- •Patients whose wounds are up to 27cm in length (as measured from end to end in a straight line)
- •Patients whose wounds are expected to have low to moderate exudate.
排除标准
- •Pregnant or lactating females
- •Patients undergoing chemotherapy, radiation therapy or taking any medication which is known to adversely affect wound healing
- •Patients with a known medical condition or status known to delay or prevent normal wound healing such as diabetes, HIV, collagen vascular disorders and primary immune disorders
- •Patients with a known sensitivity to any components of the investigational products or other similar dressings/products
- •Patients with a history of poor compliance with medical treatment
- •Patients who have participated in the study and who healed or were withdrawn.
- •Patients who are unable to understand the aims and objectives of the trial.
结局指标
主要结局
Average wear time per patient
时间窗: 0-14 days after surgery
Average wear time per patient = Sum of evaluation dressing wear times for a patient/number of dressing applications
次要结局
- Dehiscence(0-14 days after surgery)
- Wound closure(0-30 days after surgery)
- Length of hospital stay(0-14 days after surgery)
- Clinical signs of infection(0-30 days after surgery)
- Exudate management(0-14 days after surgery)
- Dressing removal parameters(0-14 days after surgery)
- Wound visibility through the dressing (OPOV dressings only)(0-14 days after surgery)
- Complications(0-30 days after surgery)
- Dressing wear time(0-14 days after surgery)
- Infection(0-30 days after surgery)
- Condition of the surrounding skin (under the dressing)(0-14 days after surgery)
- Dressing conformability(0-14 days after surgery)
- Ease of application and removal(0-14 days after surgery)
- Patient comfort(0-14 days after surgery)