ABSTRACT
INTRODUCTION: The study was carried out to evaluate the safety of early division of the pedicled flaps and to identify the optimum day of division. METHODS: This prospective, parallel arm, open-label, noninferiority, randomized controlled trial was carried out from January 2019 to July 2020. All patients (age, ≥5 years) undergoing reconstructive procedures using pedicled flaps were randomized in 1:1 ratio to receive either early division or conventional division protocol. In the early-division group, the flap perfusion, if satisfactory on day 8 by clinical and thermographic methods, a clamp was applied on the pedicle. The clamp was gradually tightened to produce controlled delay, and perfusion assessment was repeated after complete tightening. If satisfactory, the flaps were divided. Primary endpoints were flap at 24 hours after division, day of division, and day of complete inset of the flap. Secondary end points included perfusion of the flap on day 8, morbidity parameters (wound infection/suture dehiscence, need for secondary surgery and donor site morbidity), quality of life, and function scores. RESULTS: Thirty-five patients were included in each group. The 2 groups were similar in terms of various demographic, clinicopathological variables, defect and flap characteristics. The flap survival rate was similar (P = 0.31) between the early (34/35) and standard (35/35) division groups. The early-division group had a significantly early mean day of flap division (mean difference of 12.74 days; P < 0.00001) and complete flap inset (mean difference of 12.09 days; P < 0.00001). All flaps had satisfactory perfusion on day 8. The wound infection rate was 1.33 times significantly higher in the conventional group (P = 0.033). There was a higher incidence of donor site morbidity (9% vs 0%) in the conventional group when compared with the early division group. The quality of life and function scores at 3 weeks (mean difference 2.37; P < 0.001) and 6 weeks (mean difference 3.76; P < 0.001) and adjacent joint stiffness were significantly higher in the early division group when compared with conventional group. CONCLUSIONS: The pedicled flaps can be divided significantly early at an average duration of 10 to 11 days after flap inset with increased patient satisfaction rate and with a reduced postoperative morbidity. The authors have included a diversity of pedicled flaps used in different anatomic locations. By using stratified block randomization, we could ensure that the distribution was similar between the 2 groups, thus minimizing the heterogeneity in the analysis. This could also potentially indicate the usefulness of the controlled delay technique, irrespective of the anatomic location and type of the flap.
