Clinical trial NCT04479618: Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics
Official title: A Test of the Safety, Effectiveness, and Acceptability of an Improvised Dressing for Sickle Cell Leg Ulcers in a Tropical Climate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Leg Ulcer
Keywords: sickle cell
chronic wounds
lower leg ulcer
venous ulcer
dressings, occlusive
sickle cell leg ulcer
dressings
bandages
Lead sponsor: Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA
Sponsor class: OTHER
Collaborators: name: Wound Healing Foundation
name: University Hospital of the West Indies
name: The University of The West Indies
name: Ferris Mfg. Corp.
First posted: 2020-07-21
Enrollment: 48
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A targeted-blinded, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. 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?
2. 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?
3. 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.

Closed wound - 100% epithelialized with no discernible scab or exudate production (paper napkin remains dry when lightly pressed against area, and no recurrence in the subsequent two weeks)

Safe - infection and other complications (healing-impairing maceration, keloid, and contracture rates) not statistically significantly higher than usual practice, with no major adverse events attributable to the method

Effective - ulcer closure rates or ulcer surface area reduction rates not statistically significantly lower than usual practice

Acceptable - average acceptability scores of 4 or higher on a 1 - 5 scale

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of Participants Who Experienced a Wound Complication (A Measure of Dressing Safety)
timeFrame: During the intervention, potential complications were assessed for presence at least weekly for 12 weeks
measure: Number of Participants Whose Wound Surface Area Decreased (A Measure of Effectiveness)
timeFrame: Measured at baseline and at 12 weeks.
measure: Reported Cultural Acceptability of Available Technology (Improvised) Dressings
timeFrame: At final study visit, which took place after approximately 12 weeks of study participation.
measure: Change in Patient Overall Quality of Life: ASCQ-Me Questionnaire
timeFrame: 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.
Secondary outcomes:
measure: Percent Change in Wound Surface Area From Baseline (A Measure of Effectiveness)
timeFrame: Measured at baseline and at the conclusion of the study, which is week 12.
measure: Number of Participants Whose Wound Closed in 12 Weeks
timeFrame: 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.
measure: Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability)
timeFrame: At final study visit, which took place after approximately 12 weeks of study participation.
measure: Total Materials Costs in US Dollars
timeFrame: During the intervention, measured weekly for 12 weeks. Results were totaled for the entire study duration (12 weeks).
measure: Average Number of Minutes/Week Spent Performing All Dressing Changes
timeFrame: During the intervention, measured daily for all 12 weeks.
measure: Change in Persistent Wound Pain: Faces Pain Scale - Revised (FPS-R)
timeFrame: Scores were recorded by the participants daily throughout the study. Week 1 means were compared with week 12 means.
measure: Procedural (Dressing Change) Wound Pain: Faces Pain Scale - Revised (FPS-R)
timeFrame: Scores were recorded by the participants daily throughout the study. Week 1 means were compared with week 12 means.
measure: Change in Patient Wound-specific Quality of Life: Wound-QoL Questionnaire
timeFrame: 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.
measure: Mean Number of Hours/Day the Wound Was Dependent
timeFrame: During the intervention, recorded daily on the participants' weekly data sheet for the entire 12 week study period.
Other outcomes:
Locations:
city: Mona
country: Jamaica
facility: University Hospital of the West Indies
state: Kingston
Study officials:
affiliation: Independent Nurse Researcher for Rural Tropical Areas, AND Ferris Mfg. Corp.
name: Linda L Benskin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant Plastic Surgeon, University Hospital of the West Indies
name: Rajeev Venugopal, MBBS
role: STUDY_CHAIR
References:
citation: Benskin LL. A review of the literature informing affordable, available wound management choices for rural areas of tropical developing countries. Ostomy Wound Manage. 2013 Oct;59(10):20-41.
citation: Benskin LLL. Discovering the Current Wound Management Practices of Rural Africans [Dissertation]. 2013. Available from: http://utmb-ir.tdl.org/handle/2152.3/538
citation: Scientific and Clinical Abstracts From WOCNext(R) 2022: Fort Worth, Texas diamond June 5-8, 2022. J Wound Ostomy Continence Nurs. 2022 May-Jun 01;49(3 Suppl 1):S1-S99. doi: 10.1097/WON.0000000000000882. No abstract available.