Retrospective real‐world study of Definisse threads for jaw line reshaping in Indian patients (REDEFINE JAW study)

Thread lifting is a minimally invasive aesthetic procedure that lifts and realigns sagging tissue. Definisse double‐needle threads are the latest fourth generation absorbable, monofilament, suspension barbed threads of synthetic origin with convergent bidirectional barbs. Definisse thread produces dual action; mechanical action gives a lifting effect and over a period, it promotes histological revitalizing action.


| INTRODUC TI ON
2][3] Bony resorption particularly maxilla, mandible, and zygoma along with aging and the force of gravity causes a degree of laxity in the ligamentous support, resulting in soft tissue descent. 4Fatty tissue changes vary and depend upon the facial area and depth of the fat compartment.
Resulting facial aging changes are associated with the loss of soft tissue fullness (including the malar, mandibular, mental, and perioral sites).These are often combined with hypertrophic or persistent superficial fat in the submentum, lateral nasolabial fold, jowl, and malar fat pad regions. 5,6Lower face is most significantly affected by aging process. 3,7 recent years, significant advancement has been seen in the field of facial rejuvenation with a paradigm shift from more invasive surgery to minimally invasive modalities. 2,8Minimally invasive procedures are more often been opted by patients because of their short recovery time, lesser risk and modest aesthetic improvements. 2Injectable dermal fillers combined with neurotoxins are usually preferred to address superficial wrinkles and restore facial volumes.Though, the filler can provide the volumetric restoration to the aging face, but often fails to provide adequate soft tissue repositioning and may result in an unnatural facial appearance. 2,9read lifting is a minimally invasive aesthetic procedure that lifts and realigns sagging tissue.While adding definition to facial contours by using threads that are manufactured from the similar materials used in surgery to close wounds.When placed under the skin, they can be used to tighten the tissue and reposition the superficial fat pads. 10,11Recently in India, thread lifts have become popular because of their ability to correct and reposition soft tissue laxity, at the same time ensuring shorter downtime, lesser complications, and overall lower costs.[13][14] Depending on the material that makes up the threads, they can be non-absorbable threads that remain permanently in the subdermal tissue, because they are made of non-absorbable materials, such as polypropylene, mostly used for surgical wound closures.
Absorbable threads are made of absorbable materials with a specific lifetime, due to the enzymatic action that hydrolyses them.Polydioxanone (PDO), poly-L-lactic acid (PLLA or PLL), polyglycolic acid, and poly-lactic-polycaprolactone acid (P(LA-CLA) or PLCL) are some examples of absorbable materials.6][17] Bioabsorbable suspension threads safely reposition facial tissue by anchoring and lifting ptotic facial tissue with lasting effects.It does not require long procedural time, recovery is quicker, and is well tolerated leading to immediate patient satisfaction. 15,16finisse double-needle threads are the latest fourth generation absorbable, monofilament, suspension barbed threads of synthetic origin with convergent bidirectional barbs. 11,15,18It is a co-polymer made from L-lactide and ε-caprolactone.Poly (ε-caprolactone) (PCL) is a semicrystalline material displaying rubbery properties, whereas poly (L-lactic acid) (PLL) is a crystalline and hard material.
As a copolymer, it becomes a very good alternative to commonly used threads because of its controllable elasticity and adjustability due to the capacity to change the ε-caprolactone/lactic acid molar ratios. 11,18,19Definisse double-needle 12 cm thread has two parts of 6 cm each with bidirectional and convergent spines that are found on each side.At the central part of this thread, there is a smooth area that is approximately 1 cm long.There is a straight cutedge double-needle that is 10 cm long. 11,18Definisse thread when they are implanted sub-dermally, its mechanical action along with bio stimulatory action inducing fibrosis gives lifting effect which supports and repositions sagging facial tissue.Over a period, its histological revitalizing action stimulates fibroblasts and the synthesis of collagen, hyaluronic acid, and elastin around the thread, which remains stable even after resorption of the thread beyond 12 months. 11,18Further, upon resorption, the fully biodegradable and soluble thread polymers hydrolyze into low-molecular-weight molecules, which further induce collagen and hyaluronic acid production.Overall, it is estimated that Definisse thread inserted in the tissue can last from 12 to 15 months, with a lifting duration estimated to last between 30 and 36 months. 3,18wadays, Indians with lower facial laxity often seek clinical interventions to improve jawline contouring.The objective of this study was to evaluate the real-world efficacy and safety of the Definisse double needle absorbable barbed threads used for lower facial lifting for jawline reshaping in Indian patients.

| ME THODS
This is an observational, retrospective, and real-world study.Patients who underwent treatment for lower face reshaping using Definisse double needle 12 cm threads between Jan 2022 and October 2022 and completed a minimum of 3 month of follow-up were considered for the analysis in this study.Demographic data such as age and sex of patients, treatment details like number of threads used and type of procedure, and treatment outcomes in terms of Physician and Subject Global Aesthetic Improvement scale (PGAIS and SGAIS) were recorded.
Contraindications to the thread lift procedure are recognizable personality disorders, unrealistic patient expectations, previous injection of non-absorbable filler in the same treatment area, anticoagulant therapy/bleeding disorders, substance abuse, intolerance for or allergic to PLL and/or PCL, lignocaine or epinephrine, immunologically compromising diseases, facial and/or scalp eczema or psoriasis, local or systemic infection, history of keloids or hypertrophic scarring, acne/rosacea at or near the thread entry/exit points, uncontrolled diabetes, pregnancy, and breastfeeding females.
Efficacy outcome analyses were performed immediately after the procedure compared to preprocedural and at 3 to 6-month follow-up visits using a 5-point subject and physician GAIS rating as shown in Table 1.

| RE SULTS
Fifty patients with a mean age of 47.44 years (28-72 years), and 42 (84%) females and 8 (16%) males were included in the study.Average follow-up was done at 5.14 months (range 3 to 6 months).All the patients have undergone JR procedure, while 70% of patients also underwent the MR technique simultaneously.Mean PGAIS and SGAIS showed improvement immediately after the procedure (mean scores 2.82 and 2.7, respectively) and showed further improvement at the follow-up visits (3.72 and 3.58 respectively) [Figure 1].Moreover, most of the patients immediately after the procedure rated the improvement in PGAIS and SGAIS as 3 which is much improved compared to pre-procedure appearance (78% and 66% respectively).
While at longer follow-up visits most of the patients were rated 4, that is condition improved very much with optimal aesthetic improvement on PGAIS and SGAIS (76% and 66% respectively) compared to pre-procedure appearance [Figures 2 and 3].Moreover, 88% and 76% of patients on PGAIS and SGAIS respectively showed improvement at long-term follow-up as compared to immediately after the procedure.
Common adverse reactions to the thread implantation procedure were procedure site pain (70%), bruising (48%), edema (30%), puckering (18%), nodule formation (4%), and thread protrusion (4%).Most of the adverse reactions were mild and resolved spontaneously within few days without any active intervention.Thread protrusion which occurred within the first week of procedure was treated with excision of protruding thread.Two patients with nodule formation were treated with 7 days of antibiotics, upon which it resolved.Clinical photographs of patients before the Definisse threads procedure and immediately after the thread procedure and after 3 months of follow-up are shown in Figures 4-6.65 years) participated in the study.Majority of patients (89%) considered thread lift procedures satisfactory, of which 65% considered the results "excellent" and 24% "good."Further, the optimal cosmetic effect was maintained after 6 months of treatment.Histopathological analysis of selected patients demonstrated that there is a definitive tissue lifting effect accompanied by cutaneous reaction along the length of the thread.Patients experienced minor adverse events like small ecchymosis (62%), mild erythema (40%), small hemorrhage (25%), mild transitory esthesia (6%), and mild post-operation tumefaction (40%).Overall, the study demonstrated the effectiveness of PLCL threads for tissue lifting and showed the synthesis of collagen which can provide structure and elasticity to the skin.Additionally, there was no acute inflammatory responses were elicited by the procedure. 15ngsima and colleagues conducted the prospective, evaluatorblinded study on 27 Thai patients with mild to moderate facial laxity.Our retrospective study showed that when lower face reshaping was done using jaw line reshaping technique with Definisse double needle absorbable, monofilament, suspension barbed threads, all the patients reported improvement on both PGAIS and SGAIS immediately after the procedure.This is due to the immediate lifting property of Definisse threads because of the mechanical actions of the thread and its bidirectional barbs hooking onto the tissues and locking into position. 15Further improvement at the follow-up visits was also reported in most of the patients in the current study.It is due to the delayed action of Definisse threads that can induce neocollagenesis, elastogenesis, hyaluronic acid production, and angiogenesis for up to 15 months before total reabsorption occurs, thus providing up to 36 months of progressive tissue lifting and revitalization. 11,15st of the adverse reactions reported in our study were mild and resolved spontaneously within few days without any active intervention.Barb suspension thread procedure is minimally invasive and is generally safe. 20Incidence of adverse outcomes is also depended on various factors like patient factor, operator factor, and surgical field.Majority of the adverse incidents are avoidable with careful patient selection, well-planned procedure, and proper aseptic environment while performing the procedure, and careful attention to individual anatomical structures. 20is is one of the first study conducted in Indian patients with Definisse double needle absorbable barbed threads which is made F I G U R E 6 Fourty-seven-year-old male who underwent JR and MR procedure using 2 pairs of 12 cm Definisse double needle threads (A) pre-procedure, (B) immediately after the procedure, and (C) 3 months following the procedure.
Lower-face reshaping with a 12 cm Definisse double needle was performed under local anesthesia using 2% lidocaine and adrenaline (1:100000) for each side (5-6 mL in total).Preoperative markings were performed with the patient in the sitting position, and jawline reshaping (JR) procedure was performed using two threads for each patient (one on each side), moreover, as per individual patient assessment in some patients, Malar Reshaping (MR) was also performed in same sitting using two additional 12 cm Definisse double needle threads for each patient. 11postprocedure, fusidic acid ointment was applied to the area for 1 week.To avoid thread displacement, all patients were advised to refrain from vigorous exercises, avoid dental procedures, visit saunas, or apply massage and heat to the treated area by rubbing on the treated areas for the first 4 weeks.Patients were advised to wash and dry the treated area gently without exerting force, and if applying makeup to the treated area, to do so gently.Statistical analysis was done using SPSS 10.0.Descriptive statistics were derived.Categorical data were presented as frequency and percentages.Continuous data were presented as mean and standard deviation.

1 F I G U R E 2 F I G U R E 3
Mean GAIS rating immediately after the Procedure and at the follow-up visit.Percentage of subjects showing improvement on PGAIS rating immediately after the Procedure and at the follow-up visit.4| DISCUSS IONFacial rejuvenation surgery has seen significant advancement in the recent decade and newer minimally invasive procedures are more often been opted because of their short recovery time, more safety, and modest aesthetic improvements.Recently in India as well, minimally invasive procedures particularly thread lifts were become popular because of their ability to reposition soft tissues, and at the same time ensure shorter downtime and lesser complications. 2,3,14Savoia et al. assessed outcomes of thread lift performed using reabsorbable barbed PLCL threads in eyebrow lifting, forehead lifting, mid-face lifting (zygomatic malar), upper-mandibular region lifting, and high cervical region lifting.Thirty-seven female patients (37 and F I G U R E 4 Thirty-year-old female who underwent JR and MR procedure using 2 pairs of 12 cm Definisse double needle threads (A) Preprocedure, (B) immediately after the procedure, and (C) 3 months following the procedure.F I G U R E 5 Twenty-eight-year-old female who underwent JR and MR procedure using 2 pairs of 12 cm Definisse double needle threads (A) pre-procedure, (B) immediately after the procedure, and (C) 3 months following the procedure.Percentage of subjects showing improvement on SGAIS rating immediately after the Procedure and at the follow-up visit.
All the patients underwent thread implantation along the mandibular angle with one of two Definisse, absorbable p(LA-CL) monofilaments double needle thread lengths (12 and 23 cm).Clinical improvement was assessed at baseline, immediately, and at 1 week and 1, 2, 3, 6, and 12 months follow-up.Of the 27 patients recruited to the study, 92.6% attended all follow-up visits.Clinical improvement of facial laxity was observed immediately after thread implantation.There was significant volume improvement in the jawline, nasolabial folds, and submental area at almost all follow-up visits (p-0.007), with most patients (51.9%) reporting excellent lifting effect as early as the 1-week follow-up visit.Lifting effect was reported immediately after implantation when compared to baseline.The immediate lifting effect was considered due to the mechanical tissue suspension that occurred after the implantation and most of the patients maintained this lifting effect until 6 months post-procedure.Moreover, at 12-month follow-up, 72% of patients were able to maintain the lifting effect.All patients had a mean pain score of 3.91 (scale of 0-10), which lasted for an average duration of 3.15 days.Other common adverse reactions reported in the study were edema (33.3%), bruising (81.48%), dimple formation (22.22%), and palpable nodules (11.1%).All adverse reactions were mild and resolved spontaneously without any medical intervention.3