Innovative Burn Treatment Using Tilapia Skin as a Xenograft: A Phase II Randomized Controlled Trial

2020 ◽  
Vol 41 (3) ◽  
pp. 585-592 ◽  
Author(s):  
Edmar Maciel Lima Júnior ◽  
Manoel Odorico De Moraes Filho ◽  
Bruno Almeida Costa ◽  
Andréa Vieira Pontes Rohleder ◽  
Marina Becker Sales Rocha ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Skin Substitutes ◽  
Burn Wound ◽  
Burn Treatment ◽  
Randomized Controlled ◽  
Nile Tilapia Oreochromis Niloticus ◽  
Occlusive Dressings ◽  
Skin Xenograft

Abstract Skin substitutes are considered a useful alternative for occlusive dressings in the treatment of superficial burns as they reduce the frequency of dressing replacement. This phase II randomized controlled trial aimed to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive xenograft dressing for the treatment of burn wounds in humans. In order to assess the use of tilapia skin, the following variables were evaluated: number of days for wound healing, the number of times the occlusive dressing was changed, use of anesthetics or analgesics, pain assessment using the Visual Analogue Scale, and evaluation of burn improvement on the day of dressing removal. In total, 62 participants completed the study. It was found that in participants treated with tilapia skin, complete reepithelialization occurred in significantly fewer days; reported pain intensity was lower (study arms B and C), the amount of anesthetics/analgesics required was lower (study arms B and C), and the necessity of dressing changes was significantly reduced in comparison with volunteers treated with silver sulfadiazine. In our study, the tilapia skin xenograft showed good efficacy as an occlusive biological dressing for burn wound treatment in humans.

A randomized controlled trial of hypnosis for burn wound care.

2007 ◽  
Vol 52 (3) ◽  
pp. 247-253 ◽  
Author(s):  
Shelley Wiechman Askay ◽  
David R. Patterson ◽  
Mark P. Jensen ◽  
Samuel R. Sharar
Keyword(s):  
Randomized Controlled Trial ◽  
Wound Care ◽  
Controlled Trial ◽  
Burn Wound ◽  
Randomized Controlled

scholarly journals Phase II Randomized Controlled Trial of Combined Oral laxatives Medication for BOwel PREParation (COMBO-PREP study)

Medicine ◽  
2016 ◽  
Vol 95 (7) ◽  
pp. e2824
Author(s):  
Min Jung Kim ◽  
Chang Won Hong ◽  
Byung Chang Kim ◽  
Sung Chan Park ◽  
Kyung Su Han ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Phase Ii ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Food allergy symptom self-management with technology (FASST): An mHealth intervention to address psychosocial outcomes in caregivers of children with newly diagnosed food allergy: Protocol for a pilot randomized controlled trial. (Preprint)

2020 ◽  
Author(s):  
Brantlee Broome ◽  
Mohan Madisetti ◽  
Margaret Prentice ◽  
Kelli Wong Williams ◽  
Teresa Kelechi
Keyword(s):  
Randomized Controlled Trial ◽  
Food Allergy ◽  
Phase I ◽  
Phase Ii ◽  
Controlled Trial ◽  
Self Management ◽  
Newly Diagnosed ◽  
Randomized Controlled ◽  
Allergy Symptom

BACKGROUND Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis; a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including: fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. OBJECTIVE In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management mHealth smartphone app intervention Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. METHODS This pilot study uses pre-formative qualitative work (Phase I) to inform a 4 -week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (<18 years old) with established food allergy (diagnosed  1 year) will participate in semi-structured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children with a newly diagnosed food allergy (diagnosed  90 days) will be randomized 2:1 to receive FASST intervention (n = 20) or the control condition (basic app with educational resources) (n = 10). Process measures include feasibility, caregiver acceptability, adherence and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life mesasured at baseline,week 4, and at 3-months post study completion. RESULTS Pre-formative Phase I study activities have been completed and Phase II participant enrollment into the randomized controlled trial is expected to commence 2021. CONCLUSIONS With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time-period in the caregiving/condition trajectory. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04512924 (posted 08/14/2020).

scholarly journals Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial

Critical Care ◽  
2015 ◽  
Vol 19 (1) ◽  
Author(s):  
Rodrigo Palacio de Azevedo ◽  
Flávio Geraldo Resende Freitas ◽  
Elaine Maria Ferreira ◽  
Luciano Cesar Pontes de Azevedo ◽  
Flávia Ribeiro Machado
Keyword(s):  
Randomized Controlled Trial ◽  
Organ Dysfunction ◽  
Phase Ii ◽  
Controlled Trial ◽  
Mechanically Ventilated ◽  
Mechanically Ventilated Patients ◽  
Randomized Controlled ◽  
Ventilated Patients
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