A Test of the Safety, Effectiveness, and Acceptability of an Improvised Dressing for Sickle Cell Leg Ulcers in a Tropical Climate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Patient Overall Quality of Life: ASCQ-Me Questionnaire
研究概览
简要总结
One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months). SCLUs heal very slowly, and sometimes they never close. SCLU patients would benefit from an economical, less painful, dressing option. In addition, because SCLUs often compromise education and employment opportunities, improving wound care for this population benefits their entire community.
This three-armed evaluator-blinded randomized controlled trial will determine if a cut-to-fit food-grade plastic-based improvised dressing decreases pain, improves quality of life, and is safe, effective, and acceptable for managing SCLUs in Jamaica. The negative control will be usual practice, and the positive control will be the advanced wound dressing with the strongest evidence supporting its use in a tropical climate (polymeric membrane dressing).
Patients with SCLUs will be actively recruited from three adjacent parishes. The first 120 SCLU patients meeting study criteria presenting to UHWI, Mona, will be randomized immediately after initial cleansing/debriding into group (1) current usual practice, group (2) improvised dressings, or group (3) advanced dressings. Data will be added to each participant's data collection tool weekly. Results will be reported using descriptive statistics and ANCOVA. The expected outcome is both improvised and advanced dressing superiority to usual practice.
Because proposed improvised dressing materials are easily obtainable, their use would increase the capacity of wound patients to safely and effectively care for themselves.
Signed informed consent will be obtained from patients/parents. Only principal research investigators will have access to participant confidential information. The literature review demonstrates that risks are not higher than usual practice.
详细描述
This study's primary purpose is to determine if an improvised dressing, made from inexpensive materials available for purchase in rural as well as urban settings, is a safe and effective, culturally and medically acceptable choice for managing sickle cell leg ulcers in a tropical climate. Three research questions will be addressed:
- Is the improvised dressing, consisting of a cut-to-fit new plastic bag sealed at the periwound with zinc oxide paste, safe and effective (see definitions, below) when compared with usual practice (saline-soaked gauze) and when compared with an advanced wound dressing (PMD), on sickle cell leg ulcers (SCLUs) in Jamaica?
- Does use of the improvised dressing, when compared with usual practice, improve the quality of life of patients (decrease pain, increase ability to engage in desirable activities, decrease wound-related materials costs, decrease time required to perform dressing changes, improve Wound QoL scores, and improve ASCQ-Me pencil-and-paper interview scores) with SCLUs in Jamaica?
- Is the improvised dressing culturally acceptable to health care providers, patients, and families for managing SCLUs in Jamaica?
The expected study outcome is improvised dressing superior effectiveness and quality of life, when compared with usual practice, without increased safety and acceptability issues. The improvised dressing is likely to be the least expensive choice, with the added benefit of being available as first aid treatment throughout Jamaica. The advanced dressing is likely to be more expensive with respect to materials costs, although fewer dressing changes are anticipated and pain medication expenses are likely to be reduced. Based upon the review of the literature, no serious infections or other safety issues are anticipated for any group. However, to ensure that complications are not overlooked, in addition to the onsite researchers' vigilance, weekly wound photos will be assessed for complications (signs of infection, wound deterioration, or clinically relevant maceration) by two off-site blinded wound experts.
Definitions:
Sickle cell leg ulcer - a wound in a HbSS or HbSβ0 positive patient, open greater than one month, below the level of the knee excluding the plantar surface of the foot.
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
- Single (Outcomes Assessor)
盲法说明
off-site wound experts and the local physicians verifying wound closure and/or complications will be blinded to the randomization group
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with HbSS or HbSβ0 sickle cell disease
- •Ages 13 - 70 years at study initiation (able to comprehend and give consent)
- •Males and females, pregnancy is not an issue
- •Open wound below the knee, not including the plantar surface of the foot
- •Wound open for longer than one month (defined as a chronic SCLU)
- •Traumatic, spontaneous, or recurrent SCLU (all etiologies)
排除标准
- •Patient younger than 13 years of age at study initiation
- •Patient older than 70 years of age at study initiation
- •Wound open for less than one month by conclusion of study enrollment period (acute wounds could be traumatic wounds unrelated to sickle cell diagnosis)
- •Diagnosis of cancer, hypertension, or chronic renal failure
- •Diabetes (will screen for undiagnosed diabetes)
- •Active wound infection (evidenced by clinical signs of malodor, dark-colored or thick drainage, or significantly increased warmth at the periwound) which is not resolved by the conclusion of the study enrollment period
- •Osteomyelitis (if osteomyelitis is suspected, an ESR will be drawn; > 70mm/h with high platelet levels and low serum albumin warrants a bone biopsy)
- •Hydroxyurea use (may be a confound because it reduces inflammation and negates much of the pathology of SSD - may choose to abstain for the study)
结局指标
主要结局
Change in Patient Overall Quality of Life: ASCQ-Me Questionnaire
时间窗: Measured at baseline and weekly during the intervention, for 12 weeks. However, the change calculated here is only the difference between baseline and final (week 12) scores for the 5 parameters. Positive differences indicate improved scores.
The Adult Sickle Cell Quality of Life Measurement Information System tool (ASCQ-Me) Emotional, Pain, Social Functioning, Stiffness, and Sleep Impact Short Forms were administered by interview or self-administered (pencil \& paper). Each of these 5 forms is scored from 5 to 25, for a minimum of 25 and maximum of 125 total score. Higher scores indicate better self-reported overall sickle-cell disease-related health. (see Limitations) The tool developers expect results to be compared with a reference population whose T scores are provided in their guidance, but only the raw scores are reported here. Also, only the change in the means, from baseline to week 12 (the final scores), for the sum of the five parameters is reported here. This simple calculation does not account for outliers. A more detailed analysis can be requested from the researchers.
Reported Cultural Acceptability of Available Technology (Improvised) Dressings
时间窗: At final study visit, which took place after approximately 12 weeks of study participation.
Acceptable was defined in the study proposal as an average score of \> 4.0 Question: Does the study dressing's unconventional nature make it unacceptable to you? 5 point Likert scale (higher scores indicate increased acceptability): 5 - it is not a problem at all 4 - it is an unimportant problem 3 - it is a concern 2 - it is a serious problem 1 - it is so much of a problem that I would not use it
Number of Participants Who Experienced a Wound Complication (A Measure of Dressing Safety)
时间窗: During the intervention, potential complications were assessed for presence at least weekly for 12 weeks
If wound infection, healing impairing maceration, wound deterioration, etc. are suspected by the patient, the two blinded off-site observers viewing wound photos, or a member of the research study team, all dressings will be removed and the ulcer will be evaluated by a blinded to treatment group member of the medical staff at UHWI who is not involved in the study. Patients and families will be instructed to report any delayed complications, such as wound recurrence, noted within 3 months of study completion. All observed complications were mild pseudomonas infections, and all resolved with the application of dilute vinegar for fewer than two weeks.
Number of Participants Whose Wound Surface Area Decreased (A Measure of Effectiveness)
时间窗: Measured at baseline and at 12 weeks.
Subtract the initial wound surface area from the final wound surface area. If the result is a positive number, the wound size remained the same or increased. If the number is negative, the wound size decreased. This is a dichotomous outcome.
次要结局
- Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability)(At final study visit, which took place after approximately 12 weeks of study participation.)
- Total Materials Costs in US Dollars(During the intervention, measured weekly for 12 weeks. Results were totaled for the entire study duration (12 weeks).)
- Mean Number of Hours/Day the Wound Was Dependent(During the intervention, recorded daily on the participants' weekly data sheet for the entire 12 week study period.)
- Percent Change in Wound Surface Area From Baseline (A Measure of Effectiveness)(Measured at baseline and at the conclusion of the study, which is week 12.)
- Number of Participants Whose Wound Closed in 12 Weeks(Assessed Weekly. Closed by the end of the 12 week study period, or not closed by the end of the 12 week period. Verified 2 weeks later. This is a dichotomous variable.)
- Average Number of Minutes/Week Spent Performing All Dressing Changes(During the intervention, measured daily for all 12 weeks.)
- Change in Persistent Wound Pain: Faces Pain Scale - Revised (FPS-R)(Scores were recorded by the participants daily throughout the study. Week 1 means were compared with week 12 means.)
- Procedural (Dressing Change) Wound Pain: Faces Pain Scale - Revised (FPS-R)(Scores were recorded by the participants daily throughout the study. Week 1 means were compared with week 12 means.)
- Change in Patient Wound-specific Quality of Life: Wound-QoL Questionnaire(Measured at baseline and weekly during the intervention, for 12 weeks. Only the change between the baseline score and the week 12 score is reported.)
研究者
Linda Benskin
Principle investigator
Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA