A Randomized Study Evaluating Clinical Efficacy and Safety of Trusteel® and Ethisteel® Surgical Steel Sutures for Sternal Closure in Subjects Undergoing Surgical Procedures by Sternotomy.

INTRODUCTION: Sternal dehiscence and other post-sternotomy complications, viz. superficial and deep sternal wound infection, mediastinitis, and sternal instability increase the risk of mortality. Sternotomy closure with steel sutures results in a low complication rate. Therefore, this study compared the clinical equivalence of Trusteel® (Healthium Medtech Limited, Bengaluru, India) and Ethisteel® (Ethicon, Johnson & Johnson, Cincinnati, USA) surgical steel sutures for sternal closure following median sternotomy. METHODS: The primary endpoint of this prospective, single-blind, multicentric, two-arm, randomized (1:1) study (April 2021-April 2023) was a comparison of the proportion of subjects having sternal dehiscence within 26 weeks of the median sternotomy closure between Trusteel® (n=33) and Ethisteel® (n=34) groups. Secondary endpoints comprised an assessment of intraoperative suture handling, the incidence of mortality and other complications of sternal closure, operative time, intensive care unit (ICU)/hospital stay, return to normal day-to-day activities and work, subject satisfaction and general well-being, and adverse events in both groups. A statistically significant result between the groups was considered at p<0.05. RESULTS: No incidence of sternal dehiscence or other post-operative complications were recorded. A significant difference (p<0.05) in the stretch capacity of Trusteel® and Ethisteel® sutures was noted; otherwise, ease of passage, knot holding, knot security, knot tie-down smoothness, and memory of both sutures had comparable ratings. Operative time, ICU/hospital stay, and return to normal day-to-day activities and work were comparable between the groups. Improvement in post-operative functional abilities, quality of life, and health status was evident in both groups and was comparable. CONCLUSION: Trusteel® surgical steel suture is clinically equivalent to Ethisteel® surgical steel suture and is safe and effective for sternal closure following median sternotomy.

Functional Outcomes Following Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Using the Sironix Titanium Button and the Polyetheretherketone (PEEK) Button: A Retrospective Observational Study.

Background Anterior cruciate ligament (ACL) injury is most common among athletes compared to the general population. ACL reconstruction is a clinical standard for restoring joint mechanical stability and enabling sports return. The purpose of the study is to evaluate the safety and functional outcomes after arthroscopic ACL reconstruction using the Sironix titanium button and the polyetheretherketone (PEEK) button. Methods A total of 31 subjects who have undergone arthroscopic ACL reconstruction using the Sironix titanium button and PEEK button between August 2022 and January 2023 were included in the study. Demographic data, surgery details, and other baseline characteristics of the subjects were collected from the hospital records. The primary objective of the study was to assess the functional outcome using the International Knee Documentation Committee (IKDC) questionnaire. The secondary objectives were to determine the pre- and post-surgery activity levels using the Tegner Activity Score (TAS) and Lysholm score. Quality of life evaluation was done by using the Quality of Life (QoL) subscale from the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Single Assessment Numerical Evaluation (SANE). Device-related adverse effect information was recorded. Results The mean (SD) of the total IKDC score of 31 subjects at baseline and post-surgery was 51.4 (2.84) and 91.8 (2.59) out of 100, respectively. The mean (SD) of TAS pre-injury and post-surgery was 5.3 (1.47) and 5.4 (1.38) out of 10, respectively. The total mean (SD) value of the total Lysholm Score at baseline and post-surgery was 53.9 (3.72) and 91.4 (3.61) out of 100, respectively. The mean (SD) value of the quality of life subscale of the KOOS score was 91.2 (3.91) out of 100. The total mean (SD) value of the SANE score that had affected joint/region of interest today was 97.4 (1.78), while for the opposite side today, it was 99.5 (0.85) out of 100. There were no adverse device effects reported in this study. Conclusion Based on the score assessment, it was observed that the performance of Sironix knee implant devices, Proloop-Titanium adjustable loop button, T-Button A® Closed PEEK button, and Surestitch® All Inside Meniscal Repair Implant (Healthium Medtech Limited, Bengaluru, Karnataka, India) was effective and safe with no adverse effects. Therefore, Sironix knee implants are considered safe and effective in ACL reconstruction and meniscus repair surgery.

A Randomized, Single-Blind Study Comparing the Clinical Equivalence of Truglyde Fast® and Safil Quick® Polyglycolic Acid Fast-Absorbing Sutures for Episiotomy Repair Following Vaginal Delivery.

INTRODUCTION: Episiotomy, the deliberate surgical incision on the vaginal orifice during vaginal delivery, requires prompt repairing of the incised tissue. It may be associated with bleeding, infection, dehiscence, dyspareunia, short-term pain, and prolonged hospital stay. The outcome of surgery depends on the suture material and technique to repair the episiotomy. OBJECTIVE: We aim to subjectively assess perineal pain and maternal morbidity following episiotomy repair with Truglyde Fast® (Healthium Medtech Limited, Bengaluru, India) and Safil Quick® (B. Braun Medical Private Limited, Mumbai, India) polyglycolic acid fast-absorbing suture. MATERIALS AND METHODS: This multicentric, prospective, randomized (1:1), two-arm, parallel-group, single-blind study was started in August 2020 and completed in March 2021. Ninety-nine primiparous or multiparous eligible women requiring episiotomy were recruited to Truglyde Fast® (n=51) and Safil Quick® (n=48) groups. The primary outcome measure was post-episiotomy perineal pain to be assessed using a visual analog scale (VAS). Secondary endpoints included evaluation of local anesthesia (quantity), intraoperative suture handling, number of sutures utilized, time spent for episiotomy repair and complete healing, analgesic number and dosage, early and late wound complications, presence of residual suture and frequency of re-suturing, resumption of sexual activity and dyspareunia, and adverse events. The threshold to discriminate significant from non-significant outcomes was p<0.05. RESULTS: At all visits, a non-significant change in perineal pain was noted between Truglyde Fast® and Safil Quick® groups. A significant difference (p<0.05) in the number of sutures used and intraoperative handling characteristics was observed between thegroups. Results of other secondary endpoints showed non-significant differences. CONCLUSION: Truglyde Fast® and Safil Quick® polyglycolic acid fast-absorbing sutures are clinically equivalent. Both sutures are safe and effective for episiotomy repair following vaginal delivery with minimal perineal pain and risk of maternal morbidity.

Clinical Equivalence of Trubond® and Ethibond® Braided Polyester Sutures for Valvular Prosthesis Fixation During Aortic or Mitral Valve Replacement: A Single-Blind Randomized Controlled Trial.

Background Paravalvular leak (PVL) following valve replacement is a serious cardiovascular complication that increases morbidity and mortality. Valve replacement with the interrupted suture technique using polyester suture provides adequate tensile strength and reduces the probability of tissue reaction. This study compared the clinical equivalence of Trubond®(Healthium) and Ethibond® (Ethicon, Johnson & Johnson) braided polyester sutures for valvular prosthesis fixation using interrupted suturing, with respect to the proportion of subjects having PVL after aortic valve (AV) or mitral valve (MV) replacement. Methodology Patients undergoing AV/MV replacement were enrolled and randomized in this study. The primary endpoint of this prospective, multicentric, two-arm, randomized (1:1), parallel-group, single-blind study (December 2020-October 2022) was the presence of PVL in Trubond® (n = 40) and Ethibond® (n = 42) groups within 26 weeks of surgery. The secondary endpoints included event rate of all-cause mortality, cardiac death, stroke, myocardial infarction, re-hospitalization, re-intervention, wound infection, operative time, intraoperative suture parameters, postoperative hospital stay, time to resume normal activities and work, quality of life, patient satisfaction, and adverse events in both groups. Results Patients who underwent AV/MV replacement and were followed up until 26 weeks had no incidence of PVL or other postoperative complications. No requirement for readmission or re-intervention was noted in both groups. Intraoperative suture handling characteristics, operative time, and hospital stay were also comparable between the groups. With each follow-up, subjects in both groups exhibited improved postoperative functional abilities, quality of life, and health status. Conclusions Trubond® braided polyester suture is clinically equivalent to Ethibond® braided polyester suture. Trubond® suture is safe and effective for valvular prosthesis fixation in patients undergoing AV or MV replacement.

Clinical Equivalence of Trusynth® and Vicryl® Polyglactin 910 Sutures for Subcutaneous Tissue Closure During Cesarean Delivery: A Single-Blind Randomized Controlled Trial.

Background Post-cesarean complications such as surgical site infection (SSI), bleeding, and dehiscence may occur after cesarean delivery. Subcutaneous tissue closure will reduce these complications. With this background, this study assessed the clinical equivalence of Trusynth® and Vicryl® polyglactin 910 sutures for subcutaneous tissue closure. Methods In this randomized, single-blind study (from January 5, 2021 to December 24, 2021), a total of 113 women with a singleton pregnancy scheduled for cesarean section were included in the study and randomized to Trusynth® (n=57) and Vicryl® (n=56) group. The primary endpoint was the incidence of subcutaneous abdominal wound disruption within six weeks of cesarean delivery. The secondary endpoints included postoperative complications (SSI, hematoma, seroma, and skin disruptions), operative time, intraoperative handling characteristics, postoperative pain, hospital stay, time taken to return to normal activities, suture removal, microbial deposits on sutures, and adverse events. Results No incidence of subcutaneous abdominal wound disruption was recorded. Non-significant differences in intraoperative handling parameters (except memory, p=0.007), postoperative pain, skin disruption, SSI, hematoma, seroma, hospital stay, and time to return to normal activities were observed between Trusynth® and Vicryl® groups. Conclusion Both Trusynth® and Vicryl® polyglactin 910 sutures can be regarded as clinically equivalent. These are safe and effective for subcutaneous tissue closure during cesarean section with minimal risk of subcutaneous abdominal wound disruptions.

Clinical Equivalence of Monoglyde® and Monocryl® Absorbable Poliglecaprone-25 Sutures: A Single-Blind, Randomized Study.

OBJECTIVES: Poliglecaprone-25 is a synthetic monofilament suture commonly used for post-cesarean subcuticular skin closure. The present study was designed to assess the effect of subcuticular skin closure using Monoglyde® vs. Monocryl® poliglecaprone-25 absorbable sutures on the risk of wound composite outcomes in the first 30 days post-partum [surgical site infection (SSI), wound dehiscence, hematoma or seroma]. STUDY DESIGN: This is a prospective, single-blind, randomized (1:1), multicentric, two-arm study performed between September 2020 and December 2021 at two different centers across India. Women (18-40 years) with a singleton pregnancy requiring cesarean delivery were randomized to Monoglyde® (n=62) or Monocryl® (n=62) suture groups. The primary endpoint is the incidence of wound composite outcomes in the first 30 days post-partum (SSI, wound dehiscence, seroma, or hematoma). In addition, the secondary outcomes, incidence of wound composite outcome at all visits (till four months), suture extrusion and loosening, suture removal and evaluation of microbial deposits on sutures (in case not absorbed or infection), operative time, intraoperative suture handling, postoperative pain, return to normal day-to-day activities, modified Hollander cosmesis score, subject satisfaction score, and adverse events were noted. RESULTS: Non-significant difference between the groups regarding demographic characteristics and primary endpoint; the incidence of wound composite outcome was observed. Moreover, no significant difference in suture extrusion and loosening, suture removal and evaluation of microbial deposits on sutures, operative time, intraoperative suture handling, pain, return to normal day-to-day activities, modified Hollander cosmesis, and subject satisfaction score were registered between the groups. CONCLUSIONS: This study establishes the clinical equivalence of Monoglyde® and Monocryl® poliglecaprone-25 sutures, and both sutures can be used for subcuticular skin closure following cesarean delivery with minimal risk for wound complications.

A Single-Centre, Retrospective, Observational Study to Assess Safety and Functional Outcomes of Arthroscopic Meniscal Repair Using Surestitch All Inside Implant.

Introduction The meniscus plays a vital role in maintaining knee stability. It acts as a shock absorber and knee filler. The incidence of meniscal tears is estimated to be 60 per 100,000 people. Due to lack of awareness among patients, only 10% of the meniscus tears were treated through partial or total meniscectomy. Recently, the concept of meniscus preservation surgery has emerged to preserve early degeneration of the knee joint. In the current retrospective study, safety and functional outcomes of arthroscopic meniscal repair surgery using Surestitch All inside implants (Sironix Arthroscopy Solutions, Healthium Medtech Limited, Bengalaru, India) were assessed. Methods Fifty-two patients who underwent arthroscopic meniscal repair surgery between January 2019 to July 2022 at Epic Hospital in Gujarat, India, were enrolled in the study. Retrospective data including demographics, injury details, surgery details, and post-surgery complications were collected from the medical records of the patients. Then, the patients were followed up telephonically to document safety and functional outcomes using patient-reported instruments such as International Knee Documentation Committee (IKDC) score, Single Assessment Numeric Evaluation (SANE) score, Tegner activity level, and Lysholm knee score. Results The recruited patients had the mean age, height, and weight of 37.56 ± 12.52 years, 167.61 ± 7.28 cm, and 75.87 ± 10.7 kgs, respectively. Seventy-one percent of patients were male and 29% were female. Majority of the patients had the routine of doing mild exercise. During pre-surgery representations, medial meniscal tear was observed in majority of patients. The mean length of the tear was 1.32 ± 0.84 cm. In addition, patients were also diagnosed with anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL) tears, and osteochondral defects. Surgeries for meniscal repair were performed using Surestitch All inside implant. In patient-reported outcomes, the mean IKDC, SANE, and Lysholm scores were 81.72 ± 14.23, 94.02 ± 13.79, and 93.32 ± 14.63, respectively. When the mean Tegner scores of pre-injury and post-surgery periods were compared, this resulted in no significant difference (p>0.05) in the activity levels of the patients. Conclusion Based on our findings, arthroscopic meniscal repair with Surestitch All inside meniscal repair implant provides satisfactory and favorable functional outcomes with no remarkable adverse events.

Assessment of Safety, Efficacy, and Functional Outcomes After Rotator Cuff Repair Using Ceptre® Titanium Screw Anchor: A Retrospective Study.

Background Rotator cuff tears (RCTs) are the most common cause of shoulder disability. RCT is characterized by progressive wear and tear of the tendon tissue over time. The incidence of cuff tears ranges from 5% to 39%. With increasing advancements in the surgical sector, an upward trend has been observed in repair surgeries where torn tendons are repaired arthroscopically by inserting surgical implants. With this background, this study aimed to assess the safety, efficacy, and functional outcomes after RCT repair using Ceptre® titanium screw anchor implants. Methodology This retrospective, observational, single-center, clinical study was conducted at Epic Hospital in Gujarat, India. Patients who underwent rotator cuff repair surgery between January 2019 and July 2022 were recruited and followed up in December 2022. Baseline characteristics and surgical and post-surgical details were collected from patient medical reports and post-surgery progress data were documented through telephonic follow-up. The functional outcomes and efficacy of the implant were assessed using the American Shoulder and Elbow Surgeons (ASES) form, Shoulder Pain and Disability Index (SPADI) score, Simple Shoulder Test (SST), and Single Assessment Numeric Evaluation (SANE) score. Results The mean age of the recruited patients was 59.74 ± 8.91 years. Among the recruited patients, 64% were females and 36% were males. About 85% of patients had a right shoulder injury and 15% of patients (n = 6/39) had a left shoulder injury. Further, 64% (n = 25/39) of patients had supraspinatus tears, whereas 36% (n = 14) of patients had both supraspinatus and infraspinatus tears. The mean ASES, SPADI, SST, and SANE scores were observed to be 81.43 ± 14.20, 29.41 ± 12.6, 75.41 ± 12.96, and 94.67 ± 7.50, respectively. No adverse events, re-injuries, or re-surgeries were reported by any of the patients during the study period. Conclusions Our findings suggest that arthroscopic rotator cuff repair using Ceptre Knotted Ultra-High-Molecular-Weight Polyethylene Suture Titanium Screw Anchor resulted in favorable functional outcomes. Thus, it could be a considerable implant for a successful surgery.

A Prospective Randomized Controlled Trial Comparing Clinical Equivalence of PD Synth and PDS Polydioxanone Sutures.

Introduction Incisional hernia is a common complication of midline laparotomy that may develop even after several years of surgery. Abdominal fascia closure with ideal suture material reduces the incidence of incisional hernia. This study compared the clinical equivalence of PD Synth (Healthium Medtech Limited) and PDS (Ethicon, Johnson & Johnson) slowly absorbed polydioxanone suture with respect to the occurrence of incisional hernia, following elective/emergency midline laparotomy. Methods Eighty-eight subjects undergoing elective/emergency midline laparotomy were randomized to PD Synth (n=45) and PDS (n=43) groups of this prospective, multicenter, randomized (1:1), single-blind, two-arm, parallel-group study (December 2020-May 2023). Primary endpoint was incidence of incisional hernia, occurring within six and 12 months of surgery. Secondary endpoints included incidence of fascial dehiscence, surgical site infection (SSI), suture sinus, seroma, hematoma, scar tenderness, and re-suturing, and evaluation of operative data, hospital stay, intra-operative suture handling, pain, time to return to normal day-to-day activities and work, overall patient satisfaction score, and adverse events. Results One subject in both PD Synth and PDS groups (p>0.05) developed incisional hernia at umbilicus 12 months post-laparotomy. In PDS group, one subject each had incidences of SSI on day 2, day 7, and one month, two subjects developed seroma on day seven, and one subject had readmission on one month; two subjects in PD Synth group developed superficial SSI (one month). Findings of other secondary endpoints were comparable between the groups. Conclusion Primary and secondary outcomes manifested that PD Synth and PDS slowly absorbed polydioxanone sutures are clinically equivalent, and can be used for abdominal fascial closure following midline laparotomy.

A prospective observational study of the use of desflurane anesthesia in Indian adult inpatients undergoing surgery: The Registry in India on Suprane Emergence registry.

BACKGROUND AND AIMS: Limited registry studies are available on the use of anesthetic agents. This registry was conducted to evaluate emergence outcomes in Indian adult patients undergoing surgery with desflurane anesthesia. MATERIAL AND METHODS: This multicenter, prospective, non-interventional, observational study (Registry in India on Suprane Emergence [RISE] registry) included adult inpatients who received desflurane as general anesthetic for surgical procedure of ≥2 h. Patients were stratified by age into three groups: ≥18-40 years, ≥41-65 years, and >65 years. Data on patients' demographics, practice, and usage pattern of medications were collected. The primary efficacy outcomes were time to extubation, time to response to verbal command, and time to orientation. RESULTS: Of 236 patients screened, 201 (≥18-40 years, n = 70; ≥41-65 years, n = 65; >65 years, n = 66) were enrolled in the study. Mean time to extubation observed in ≥18-40 years group was 7.2 ± 4.1 min, ≥41-65 years was 11.6 ± 8.99 min, and >65 years was 12.0 ± 10.5 min. Mean time to response to verbal command was 7.4 ± 4.3 min for ≥18-40 years, 10.9 ± 8.5 min for ≥41-65 years, and 10.0 ± 5.4 min for >65 years. Mean time to orientation was 13.0 ± 7.0 min for ≥18-40 years, 16.1 ± 12.0 min for ≥41-65 years, and 17.0 ± 8.6 min for >65 years. Incidence of nausea and retching/vomiting was observed in 8% of patients each in the postoperative period, and these complications were seen more in the >65 years age group. Overall, desflurane treatment maintained hemodynamic stability and no major airway events were reported. CONCLUSIONS: The RISE registry data suggest that desflurane-based anesthesia provides early recovery with stable hemodynamics without any airway adverse events, in a wide variety of surgical procedures.

Efficacy and tolerability assessment of cefprozil in children with acute otitis media.

Young children contract as many as six to eight upper respiratory tract viral infections per year, and these infections frequently lead to secondary bacterial infections such as acute otitis media and sinusitis. Cefprozil is an orally active third generation cephalosporin which has demonstrated activity against the gram-positive organisms Streptococcus pyogenes, pneumoniae and agalactiae and against methicilin-susceptible Staphylococcus aureus. Cefprozil is also active against various gram-ves and certain anaerobic organisms, and is stable to hydrolysis by a number of b-lactamases. Present study is an effort to study the efficacy and safety of cefprozil in children with acute otitis media. Three hundred and thirty four children aged 6 months through 12 years with clinical symptoms and tympanic membrane signs of AOM received cefprozil 30 mg/kg/day in two divided doses per day for 10 days. Clinically, 96.6% patients were cured, 2.4% improved and there was failure of therapy in 1% of the patients. There was no need for any rescue medication and any change in antibiotic in any patient. A satisfactory bacteriological outcome was (i.e. cure, presumed cure, and cure plus reinfection with a different pathogen) was achieved in 95% of patients. In conclusion, cefprozil is a well tolerated and effective drug for acute otitis media in children. Moreover, its expanded spectrum of activity, ability to achieve adequate concentrations in tissues, suitability for twice-daily dosing, and proven tolerability suggest that it is a better alternative to agents conventionally used in acute otitis media.