Antibiotic Tumescent For Chronic Wounds
ConditionNon-healing Wound
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles
About this trial
Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic wounds in the lower extremities, upper extremities or trunk, will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥18 years of age.
One or more full thickness ulcers on the lower extremity, upper extremity (excluding the hands) or trunk with a surface area exceeding 0.5 cm² (50 mm²) and less than 30 cm² (6*5 cm) after debridement (full thickness means extending through the epidermis and dermis but not involving tendon, bone or joint capsule).
Presence of a chronic wound (including venous ulcer, arterial ulcer, below knee pressure ulcer, diabetic foot ulcer, ischemic ulcer) that has existed for >4 weeks at Visit 1.
Documentation that the wound has been treated at least 2 times at the wound care center.
Disqualifiers
Participants with limb threatening infection, extensive cellulitis (≥2 cm radially beyond the borders of the wound), lymphangitis, fasciitis, deep tissue infection, abscess, pus, osteomyelitis, or other evidence of local or systemic complications of infection.
Wound size/surface area, duration, severity, or location outside of INCLUSION criteria Note: Consideration will be given to minor variation, if deemed appropriate by the medical director, and authorized.
Clinically severe wound at high risk for amputation as determined by the Medical Director.
All pressure ulcers except below knee pressure ulcers.
Trial design
Design model
Parallel
Treatments tested in this trial
CeFAZolin Injectable Solution
DrugOne gram Cefazolin reconstituted in 100 mL 0.9% Sodium Chloride (normal saline)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control Group (Standard Wound Care)No intervention 0 interventions
Group B: Treatment Group (Tumescent Antibiotic Injection)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI
Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, and the relationship to TAI. The severity of adverse events will be measured by the adverse event severity scale (1-4; Mild; Moderate; Severe; Life-threatening). The relationship of the adverse event to the study drug will be assessed by the likelihood of the relationship (Definitely; Probably; Possibly; Unrelated). Frequency of adverse events that result in discontinuation of the investigative treatment will be quantified.
Time frame
From enrollment through 6 month visit.Secondary outcomes
1
Secondary Objective - To evaluate wound size and closure.
Wound closure will be determined by the clinical practitioner at time of wound assessment at clinic follow up. If wound is not closed, wound size will be measured with a device that scans the wound and determines its area in cm\^2. If wound is closed the wound size will be returned as 0 cm\^2.
Time frame
From enrollment through 6 month visit or until wound is closed.2
Secondary Objective - Chronic-wound-related pain
Chronic wound-related pain will me be measured with a pain assessment administered every visit. The pain assessment is the PEG-3 Pain Screening Tool which consists of 3 questions; The PEG-3 answer scale ranges from 0 to 10 for each question, where 0 corresponds to no pain and 10 represents the worst pain. A combined score is generated by summing the answer to each question.
Time frame
From enrollment through 6 month visit.3
Secondary Objective - Rating Quality of life
Quality of Life (QoL) will be measured with a QoL assessment administered at every visit. The QoL assessment is the WOUND-QOL-14 QUESTIONNAIRE which consists of 14 questions. Answers to each item are coded with numbers (0='not at all', 1='a little', 2='moderately', 3='quite a lot', to 4='very much') and summed or averaged to generate a global score. A higher score denotes a lower QoL.
Time frame
From enrollment through 6 month visit.Other outcomes
1
Exploratory Objectives - Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis).
Record the number and severity of chronic-wound-related complications. 1. difference in wound size, 2. incidence and degree of infection 3. occurrence of dermatitis. 4. Difference in wound quality via visual inspection (granulation tissue, tissue necrosis, exudate, drainage).
Time frame
From enrollment through 6 month visit.2
Exploratory Objectives - Assess the number of clinical signs of infection in participants.
Record number and severity of clinical signs of infection. 1. cellulitis via visual inspection and exam, 2. pus via visual inspection and exam, 3. fever via visual inspection and exam, 4. abscess via visual inspection and exam.
Time frame
From enrollment through 6 month visit.3
Exploratory Objectives - Determine the species of pathogenic bacteria present in wound.
Species of pathogenic bacteria will be determined with a wound culture.
Time frame
From enrollment through 6 month visit.Sponsors and contacts
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Source ClinicalTrials.gov