N/A
N=48
Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics
Sickle Cell Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT04479618 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Number of Participants Who Experienced a Wound Complication (A Measure of Dressing Safety) — 4; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Practice (Device); Improvised dressing (Device); Advanced dressing (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Wound Complication (A Measure of Dressing Safety) |
4; 0; 0 | — |
| PRIMARY Number of Participants Whose Wound Surface Area Decreased (A Measure of Effectiveness) |
7; 10; 9 | — |
| PRIMARY Reported Cultural Acceptability of Available Technology (Improvised) Dressings |
4.75; 5.0; 4.27; 4.6; 4.25 | — |
| PRIMARY Change in Patient Overall Quality of Life: ASCQ-Me Questionnaire |
7.516; 4.442; 15.045 | — |
| SECONDARY Percent Change in Wound Surface Area From Baseline (A Measure of Effectiveness) |
-1.647; -25.808; -36.071 | — |
| SECONDARY Number of Participants Whose Wound Closed in 12 Weeks |
1; 0; 2 | — |
| SECONDARY Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability) |
2; 1; 2; 5; 8; 3 | — |
| SECONDARY Total Materials Costs in US Dollars |
108.354; 55.76; 574.15 | — |
| SECONDARY Average Number of Minutes/Week Spent Performing All Dressing Changes |
153.356; 144.177; 86.497 | — |
| SECONDARY Change in Persistent Wound Pain: Faces Pain Scale - Revised (FPS-R) |
4.314; 2.469; 3.36 | — |
| SECONDARY Procedural (Dressing Change) Wound Pain: Faces Pain Scale - Revised (FPS-R) |
4.23; 2.61; 3.00 | — |
| SECONDARY Change in Patient Wound-specific Quality of Life: Wound-QoL Questionnaire |
13.625; 7.692; 15.364 | — |
| SECONDARY Mean Number of Hours/Day the Wound Was Dependent |
6.808; 5.41; 7.036 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04479618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.