Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics

NCT04479618 | Completed Results FDA Device

• 1 other identifier: SCLUJamaica2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Leg Ulcer

Keywords

sickle cell; chronic wounds; lower leg ulcer; venous ulcer; dressings, occlusive; sickle cell leg ulcer; dressings; bandages

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Experienced a Wound Complication (A Measure of Dressing Safety)

  If wound infection, healing impairing maceration, wound deterioration, etc. are suspected by the patient, the two blinded off-site observers viewing wound photos, or a member of the research study team, all dressings will be removed and the ulcer will be evaluated by a blinded to treatment group member of the medical staff at UHWI who is not involved in the study. Patients and families will be instructed to report any delayed complications, such as wound recurrence, noted within 3 months of study completion. All observed complications were mild pseudomonas infections, and all resolved with the application of dilute vinegar for fewer than two weeks.

  During the intervention, potential complications were assessed for presence at least weekly for 12 weeks

• Number of Participants Whose Wound Surface Area Decreased (A Measure of Effectiveness)

  Subtract the initial wound surface area from the final wound surface area. If the result is a positive number, the wound size remained the same or increased. If the number is negative, the wound size decreased. This is a dichotomous outcome.

  Measured at baseline and at 12 weeks.

• Reported Cultural Acceptability of Available Technology (Improvised) Dressings

  Acceptable was defined in the study proposal as an average score of \> 4.0 Question: Does the study dressing's unconventional nature make it unacceptable to you? 5 point Likert scale (higher scores indicate increased acceptability): 5 - it is not a problem at all 4 - it is an unimportant problem 3 - it is a concern 2 - it is a serious problem 1 - it is so much of a problem that I would not use it

  At final study visit, which took place after approximately 12 weeks of study participation.

• Change in Patient Overall Quality of Life: ASCQ-Me Questionnaire

  The Adult Sickle Cell Quality of Life Measurement Information System tool (ASCQ-Me) Emotional, Pain, Social Functioning, Stiffness, and Sleep Impact Short Forms were administered by interview or self-administered (pencil \& paper). Each of these 5 forms is scored from 5 to 25, for a minimum of 25 and maximum of 125 total score. Higher scores indicate better self-reported overall sickle-cell disease-related health. (see Limitations) The tool developers expect results to be compared with a reference population whose T scores are provided in their guidance, but only the raw scores are reported here. Also, only the change in the means, from baseline to week 12 (the final scores), for the sum of the five parameters is reported here. This simple calculation does not account for outliers. A more detailed analysis can be requested from the researchers.

  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 (9)

• Percent Change in Wound Surface Area From Baseline (A Measure of Effectiveness)

  Measured at baseline and at the conclusion of the study, which is week 12.

• Number of Participants Whose Wound Closed in 12 Weeks

  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.

• Choice of Dressings After Study Completion (Which is a Proxy Measure for Dressing Acceptability)

  At final study visit, which took place after approximately 12 weeks of study participation.

• Total Materials Costs in US Dollars

  During the intervention, measured weekly for 12 weeks. Results were totaled for the entire study duration (12 weeks).

• Average Number of Minutes/Week Spent Performing All Dressing Changes

  During the intervention, measured daily for all 12 weeks.

Study Arms (3)

Usual practice (negative control)

ACTIVE COMPARATOR

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.

Device: Usual Practice

improvised dressings (experimental)

EXPERIMENTAL

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.

Device: Improvised dressing

advanced dressings (positive control)

ACTIVE COMPARATOR

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.

Device: Advanced dressing

Interventions

Usual Practice DEVICE

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.

Also known as: Saline Gauze

Usual practice (negative control)

Improvised dressing DEVICE

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.

Also known as: Wrap Therapy (modified for a tropical environment)

improvised dressings (experimental)

Advanced dressing DEVICE

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.

Also known as: Polymeric membrane dressings, PolyMem

advanced dressings (positive control)

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA: lead
• Wound Healing Foundation: collaborator
• University Hospital of the West Indies: collaborator
• The University of The West Indies: collaborator
• Ferris Mfg. Corp.: collaborator

Study Sites (1)

University Hospital of the West Indies

Mona, Kingston, Jamaica

Location

Related Publications (3)

• 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.

  PMID: 24106254 BACKGROUND

• Benskin LLL. Discovering the Current Wound Management Practices of Rural Africans [Dissertation]. 2013. Available from: http://utmb-ir.tdl.org/handle/2152.3/538

  BACKGROUND

• 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.

  PMID: 35639023 DERIVED

Related Links

• Update on improvised dressings project as of May 2019
• Preliminary results to be presented at NCCHC 2023

MeSH Terms

Conditions

Varicose Ulcer; Bites and Stings

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Limitations and Caveats

Due to the pandemic, clinicians hesitated to ask high-risk individuals (sickle cell) to leave home, skewing the sample towards larger, more chronic ulcers in people with poor health overall. A sudden institution of strict movement restrictions led to an abrupt halt to recruitment, transportation shortages, negative interactions with police, and even hunger. Background quality of life deteriorated. Participants had difficulty obtaining pain medications; medication reports were often unreliable.

Results Point of Contact

• Title: Linda Benskin, PhD, RN, Independent Researcher
• Organization: BenskinL

lindabenskin@utexas.edu

+1 (512) 659-0812

Study Officials

• Linda L Benskin, PhD

  Independent Nurse Researcher for Rural Tropical Areas, AND Ferris Mfg. Corp.

  PRINCIPAL INVESTIGATOR

• Rajeev Venugopal, MBBS

  Consultant Plastic Surgeon, University Hospital of the West Indies

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: off-site wound experts and the local physicians verifying wound closure and/or complications will be blinded to the randomization group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: A targeted-blinded, randomized controlled trial

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 21, 2020
• Study Start: July 6, 2021
• Primary Completion: November 20, 2021
• Study Completion: February 20, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the study results have been published, for 10 years
• Access Criteria: all interested parties

Locations

JA (1)