Dataset Information

Randomised clinical trial: Effect of administering platelet-rich fibrin to autologous fat tissue in injection laryngoplasty for vocal cord paralysis.

ABSTRACT: The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialization and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected into body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue viability by increasing adipogenesis and angiogenesis. Improvement in fat viability will improve clinical outcomes after the laryngoplasty procedure, potentially reducing the number of repeated injections needed to achieve a satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. This single-blinded randomised control trial recruit a total of 18 patients, which are then randomised into the treatment and control groups. The evaluation was done via computerized acoustic analysis/Multidimensional Voice Program (MDVP) parameters and maximum phonation time. The MDVP results and maximum phonation time in both groups showed clinical improvement after the operation with no statistically significant differences.

SUBMITTER: Reksodiputro MH

PROVIDER: S-EPMC8326719 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background:Paralysis of one vocal fold leads to glottal gap and vocal fold insufficiency that has significant impact upon a patient's quality of life. Fillers have been tested to perform intracordal injections, but they do not provide perdurable results. Early data suggest that enriching fat grafts with adipose-derived regenerative cells (ADRCs) promote angiogenesis and modulate the immune response, improving graft survival. The aim of this study is to propose ADRC-enriched adipose tissue grafts as effective filler for the paralyzed vocal fold to use it for functional reconstruction of the glottal gap. Method:This is the first phase I-IIA clinical trial (phase I/IIA clinical trial, unicentric, randomized, controlled, and two parallel groups), to evaluate the safety of a new therapy with ADRC-enriched fat grafting (ADRC: group I) for laryngoplasty after unilateral vocal fold paralysis. Control group patients received centrifuged autologous fat (CAF: group II) grafts. Overall mean age is 52.49?±?16.60 years. Group I (ADRC): 7 patients (3 males and 4 females), 52.28?±?20.95 year. Group II (CAF): 7 patients (3 males and 4 females), 52.71?±?12.59 year. Results:VHI-10 test showed that preoperative mean score was 24.21?±?8.28. Postoperative mean score was 6.71?±?6.75. Preoperative result in group I was 21.14?±?3.58 and postoperative result was 3.14?±?3.53. Preoperative result for group II was 27.29?±?10.66. Postoperative score in group II was 10.29?±?7.52. Wilcoxon and the Student t-tests showed that the patient's self-perception of posttreatment improvement is larger when ADRCs are used. Comparing pre- and posttreatment voice quality analysis, group I showed a p = 0.053. Group II showed a p = 0.007. There would be no significant differentiation between pre- and posttreatment results. This is true for group II and limited for group I. Conclusions:This prospective trial demonstrates the safety and efficacy of the treatment of glottal gap defects utilizing ADRC-enriched fat grafts. This trial is registered with NCT02904824.

Dataset Information

Randomised clinical trial: Effect of administering platelet-rich fibrin to autologous fat tissue in injection laryngoplasty for vocal cord paralysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets