NCT01035944终止不适用
Evaluation of Use of Chitosan-Based Dressings to Facilitate Safe, Effective Debridement of Chronic Wounds in Operating Room and Inpatient Ward and Minimize Bacterial Re-Colonization of Wounds.
HemCon Medical Technologies, Inc2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.
研究概览
简要总结
The purpose of this study is to determine if the use of HemCon chitosan-based dressings is effective to facilitate safe, effective debridement of chronic wounds in the operating room and inpatient ward settings and to minimize bacterial re-colonization of wounds.
详细描述
Primary objective: There are two primary objectives:
- To demonstrate that debridements performed using HemCon dressings at the bedside can be performed safely without excessive bleeding in eligible patients
- To compare the levels of bacterial load between debrided wounds treated with HemCon dressings and debrided wounds treated with gauze and saline dressings at 2 days and 5 days after debridement
Secondary objectives: The following secondary objectives will be achieved by this study:
- To determine the cost efficacy, if any, between wounds debrided at the bedside with HemCon dressings and wounds debrided in the operating room setting
- To determine the cost efficacy, if any, between wounds debrided in the operating room where hemostasis is achieved with a HemCon dressing and between debrided wounds where hemostasis is achieved with traditional cauterization methods.
- To compare comfort levels in patients treated with HemCon dressings as compared to traditional gauze dressings.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and are able to provide written informed consent.
- •Have a wound on their body with an eschar and/or significant slough present
- •Documented laboratory studies and coagulation profiles prior to the debridement (including hematocrit, hemoglobin, white blood count, total lymphocyte count, albumin, pre-albumin, HbA1C in patients with diabetes)
- •Subjects with a hemoglobin < 9 g/dL must have one unit of blood typed and cross matched prior to the debridement; all other subjects must have an active type and screen performed prior to the debridement procedure.
- •Subjects must be willing to consent to a blood transfusion in the rare event that a transfusion is necessary.
- •Must be expected to be inpatients for at least 5 days following debridement, to enable controlled dressing changes by the service.
- •Female subjects of childbearing age must not be pregnant, and must consent to utilize an appropriate method of contraception during the course of the study.
- •For subjects that are to undergo a debridement in the operating room:
- •Subjects must be sensate or have wounds that are sufficiently large to warrant a debridement in the OR
- •Wounds must require more than a simple eschar removal, or must be extensive enough that an operating room debridement would be more appropriate.
- •Subjects must be candidates for regional or general anesthesia, unless the wound occurs in an insensate body part (for example, a pressure sore in a paraplegic or quadriplegic patient, or a diabetic foot ulcer in a patient with a dense diabetic polyneuropathy).
- •For subjects that are to undergo a debridement in the bedside setting:
- •The part of the wound that is to be debrided must be mostly an eschar and necrotic tissue which is not likely to have significant bleeding.
- •Subjects must be insensate, or the wound must be less than 50 cm2 such that the use of local anesthesia in the wound can be undertaken.
排除标准
- •Pre-debridement hemoglobin level < 7.0 g/dL
- •Not candidates for or refuse blood transfusions
- •Unable to provide written informed consent
- •Subjects with sensitivity to chitosan or the gauze dressings used in this study, or any local anesthetic needed for a debridement
- •Subjects who are in the intensive care unit
- •Subjects who, in the opinion of the Investigator, may not complete the study for any reason.
- •Have grossly infected wounds that may reasonably be expected to require multiple debridement procedures prior to clearance of bacteria and nonviable tissue from the wound.
- •For wounds situated in the lower extremity, leg must have either palpable pulses or else an ABI > 0.4
结局指标
主要结局
Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.
时间窗: 2 days and 5 days after debridement.
次要结局
- Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.(2 days and 5 days after debridement.)
研究者
研究点 (2)
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