Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics (SCLUJamaica)
Sickle Cell Leg Ulcer
About this trial
This is an interventional treatment trial for Sickle Cell Leg Ulcer focused on measuring sickle cell, chronic wounds, lower leg ulcer, venous ulcer, dressings, occlusive, sickle cell leg ulcer, dressings, bandages
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)
Sites / Locations
- University Hospital of the West Indies
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Active Comparator
Usual practice (negative control)
improvised dressings (experimental)
advanced dressings (positive control)
After a member of the UHWI surgical team performs the initial cleansing/debriding, the control group (1) will have their ulcer dressed as usually done at UHWI. Wounds are dressed with saline-soaked gauze, covered with dry gauze. One wrap of stretch gauze will hold the dressing in place. Patients will clean the wound by vigorously wiping with gauze soaked in homemade normal saline (1 tsp salt/500ml water bottle), center to edges, at each dressing change, unless already very clean. Clean wounds will simply be irrigated with normal saline at each dressing change. Patients experienced with using papaya for debridement of their ulcers may apply it only to the open wound, avoiding contact with the periwound, to remove slough or eschar. If patients observe green exudate, they are permitted to add one teaspoon of vinegar to their bottle of saline. Dressings in group (1) will be changed daily. The dressings will be soaked off if they become adherent.
After initial cleansing/debriding, patients in the improvised dressing group (2) will then have a thin layer zinc oxide paste applied to the dried periwound, carefully avoiding the open wound. A piece of a clean new plastic bag (food-grade World Star 1 mil LD bags, or the equivalent, purchased from the Papine Market across John Golding Road from the University of the West Indies), cut slightly larger than the ulcer will be gently conformed to the moist wound contours and sealed onto the zinc oxide paste. The bag will be fenestrated with a small slit using a number 11 scalpel or clean scissors prior to placing it on the ulcer in order to allow excess fluid to escape. The edges of the slit will be approximated. Clean gauze will be placed lightly over the slit to capture escaping fluid. One wrap of stretch gauze will hold the dressing in place. Patients will be instructed to change the dressings daily, irrigating with normal saline at each dressing change.
After initial cleansing/debriding, the advanced dressing group (3) will have a cut piece of a 4"x24" standard (pink) polymeric membrane dressing roll large enough to extend at least 0.5 cm beyond all open and closed (inflamed or damaged) wound edges applied as per the Instructions for Use (the periwound is blotted dry, but the wound bed remains moist from the final saline rinse). One wrap of stretch gauze will hold the polymeric membrane dressing in place. The approximate open wound edges will be marked on the dressing backing. As per the manufacturer's instructions for use, patients will change the dressings when saturation reaches any of the wound edges, as indicated by a change in color on the backing of the dressing, visible through the stretch gauze. Routine rinsing will not be performed; the wounds will be rinsed at dressing changes only if visible loose debris is present.