A Test of the Safety, Effectiveness, and Acceptability of an Improvised Dressing for Sickle Cell Leg Ulcers in a Tropical Climate

Study point of contact

Rajeev Venugopal, MD
(876) 840-6190
[email protected]
Linda L Benskin, PhD
+1 (512)6590812
[email protected]

Locations

1 Jamaica site

Age

13 to 70 Years

Genotypes

HbSS

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Device

Compensation

Unknown

About the study

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.

participation requirements

– 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)

participation restrictions

– 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)

Locations

  • Mona, Kingston, Jamaica, University Hospital of the West Indies

More info

View on ClinicalTrials.gov
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