Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics
Condition: Sickle Cell Leg Ulcer
MeSH terms: Leg Ulcer; Ulcer
Study type: Interventional

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
    

Intervention name(s): Usual Practice; Improvised dressing; Advanced dressing
Intervention type(s): Device; Device; Device
Intervention description(s): A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.; A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.; A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.
Other intervention name(s): Saline Gauze; Wrap Therapy (modified for a tropical environment); Polymeric membrane dressings; PolyMem
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A targeted-blinded, randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sickle cell; chronic wounds; lower leg ulcer; venous ulcer; dressings, occlusive; sickle cell leg ulcer; dressings; bandages