Madhumithra
SRMIST, IndiaPresentation Title:
Fibrin Glue Triumphs- Sealed with success: A Randomized Clinical Trial in Cleft Palate Surgery
Abstract
Purpose: The purpose of this Randomized clinical trial
is to compare the efficacy of TISSEEL (fibrin glue) with Surgicel as a
hemostatic agent in cleft palate surgery.
Methods: This prospective randomized clinical trial consists
of 22 patients consenting to the study and they were randomly allocated to
Surgicel (Group 1) and Tisseel (fibrin glue-Group 2), with 11 patients in each. It was a parallel- group clinical trial with
balanced randomization (1:1). Patients reported to Meenakshi cleft and
craniofacial center for cleft palate surgery were included in this study. The
primary outcome measures of this study were to assess the bleeding
(Intraoperative -bleeding scale) and healing in periodic intervals (healing
chart).
Result: This study includes 22 patients, of which 8 were
bilateral cleft palate and 14 were unilateral cleft palate. The maximum width
of the cleft at the level of hard and soft palate recorded was 1.5cm and 1.8cm
respectively. On comparing the
bleeding scales among the two groups, the differences were said to be
statistically significant. (p=0.011). There were
2 reported cases of palatal fistula in Surgicel group I in the 9th
and 13th month of follow-up our study occurrence of palatal
fistula ranged 4.5% in the Surgicel group and 0%the in the Tisseel group.
Conclusion:
By comparing bleeding and
wound healing in primary palate repair defects, The Tisseel group patients
significantly showed better results compared to the Surgicel group. The
tolerance to Tisseel was also evident by the way of reduced inflammation and
less complications in that group.
Biography
K. G.
Madhumithra is a
Gold Medallist in Oral & Maxillofacial Surgery, recognized for her academic
excellence, innovative research, and clinical expertise. She has received
multiple awards at national and state forums, including the Best Paper
Presentation Award at the 11th National Triple O Conference (2022)
for her work. she also selected for the prestigious Dr. C. K. Dhanasekaran
Trophy by the TN–PY AOMSI for her research in the field. Her
scientific contributions include award-winning papers and posters at various
conferences, along with notable presentations such as “TISSEEL – A Fibrin
Sealant.” She holds two patents registered under The Patents Act, 1970,
reflecting her commitment to surgical innovation. She is professional interests span advanced maxillofacial surgical
techniques, biomaterials, and evidence-based patient care. She actively
contributes to academic platforms, disseminating knowledge and sharing clinical
insights with peers and trainees. Her work exemplifies the integration of
innovation, precision, and patient-centered outcomes, making her a valuable
contributor to the global oral and maxillofacial surgery community.
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