Materiovigilance of unidirectional barbed and poliglecaprone 25 nonbarbed sutures used for intraoral incision closure: An open-label prospective study,Jaspreet Kaur Deo1, Harmeet Singh Rehan2, Pravesh Mehra1, : Indian Journal of Pharmacology

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Year : 2022 \| Volume : 54 \| Issue : 5 \| Page : 345--348

Materiovigilance of unidirectional barbed and poliglecaprone 25 nonbarbed sutures used for intraoral incision closure: An open-label prospective study

Jaspreet Kaur Deo¹, Harmeet Singh Rehan², Pravesh Mehra¹,
¹ Department of Dental and Oral Surgery, Lady Hardinge Medical College, New Delhi, India
² Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India

Correspondence Address:
Jaspreet Kaur Deo
Lady Hardinge Medical College, New Delhi - 110 001
India

Abstract

INTRODUCTION: The adverse events of sutures used for the closure of surgical incisions influence clinical outcomes. Literature on the safety profile of the application of unidirectional barbed sutures in oral and maxillofacial surgery is scarce. Hence, focused materiovigilance was done to monitor and compare the adverse events of unidirectional barbed and poliglecaprone 25 nonbarbed sutures for intraoral incision closure. METHODS: In a prospective randomized comparative study, 64 patients requiring intraoral incision closure were randomized to receive either unidirectional barbed or poliglecaprone 25 nonbarbed sutures. Postoperatively, patients were monitored for any adverse events for 15 days. Causality association of adverse events with sutures was done using the European Commission directives on safety reporting of medical devices. RESULTS: Adverse events observed with unidirectional barbed suture were suture extrusion (n = 7; 21.875%) and suture discomfort (n = 3; 9.375%). While subjects who received poliglecaprone 25 suture experienced suture discomfort (n = 6; 18.75%) and knot unraveling (n = 2; 6.25%). The number of adverse events in both groups was statistically comparable (P = 0.78). Causality assessment of adverse events was probable for suture extrusion and discomfort with nonbarbed and barbed sutures, while it was possible for knot unraveling for nonbarbed sutures. CONCLUSION: Both types of study sutures were associated with minor severity adverse events when used for the closure of intraoral surgical incisions. Suture extrusion had a probable causal association with barbed suture. Knot unraveling was possibly associated with the nonbarbed suture. Both types of suture materials were equally safe in oral and maxillofacial intraoral surgical incision closure.

How to cite this article:
Deo JK, Rehan HS, Mehra P. Materiovigilance of unidirectional barbed and poliglecaprone 25 nonbarbed sutures used for intraoral incision closure: An open-label prospective study.Indian J Pharmacol 2022;54:345-348

How to cite this URL:
Deo JK, Rehan HS, Mehra P. Materiovigilance of unidirectional barbed and poliglecaprone 25 nonbarbed sutures used for intraoral incision closure: An open-label prospective study. Indian J Pharmacol [serial online] 2022 [cited 2023 Jun 2 ];54:345-348
Available from: https://www.ijp-online.com/text.asp?2022/54/5/345/363397

Full Text

Introduction

Concerns for patient safety with regard to the use of pharmaceuticals trace its roots to the thalidomide tragedy in 1961, which ultimately led to the establishment of organizations such as the United Kingdom's Committee on the safety of drugs in 1963 and the WHO program for international drug monitoring in 1968.[1] Later, the WHO extended its pharmacovigilance program to more than 150 countries and also widened its scope to monitor the biological in 1947,[2] vaccines in 1999,[3] and medical devices[4] in 2003.

Materiovigilance can be defined as the science and activities related to the detection, assessment, understanding, and prevention of any possible adverse events related to the use of medical devices. The WHO defined a medical device as “An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose.”[5] Like pharmaceuticals, medical devices (Class C and D) undergo various phases of clinical trials to establish their safety and efficacy during their development. However, the number of patients included in these clinical trials is limited to the detection of their common adverse effects. Hence, post-authorization period safety update reports for medical devices are important to detect the less frequent adverse effects. Materiovigilance-related activities aid in the constant improvement of their safety. Reports on less operative and defective medical devices have been published over the years.[6],[7],[8],[9],[10] Medical device-related adverse events include incubator short circuit-related newborn mortality,[6],[7] magnetic pull of iron cylinder in magnetic resonance imaging chamber led to fatality,[8] and pacemaker failure-related deaths.[9],[10] Monitoring and analysis of such incidences have led to the improvement and withdrawal of several unsafe and ineffective medical devices. Similarly, there have been numerous instances where sutures were withdrawn.[11]

Barbed suture is a knotless tissue approximation device with barbs projecting along its longitudinal axis, which was approved by the US Food and Drug Administration in 2004.[12] The barbs of these sutures anchor in the soft tissues, with uniform distribution of tensile strength across the incision line, and eliminate the need for knots. This device accelerates suture placement, thereby reducing intraoperative closure time and overall operating duration. The application of barbed suture has been extensive in plastic, orthopedic and gynecologic surgeries,[13] but its application in oral and maxillofacial surgeries is limited.

The clinical outcomes of a surgery may depend on the appropriate selection of the suture material based on their surface texture, absorption profile, and the surgical site.[14] Hence, there was a need to obviate the lacuna in literature regarding the application of unidirectional barbed sutures in oral surgery. The rationale of the study is to ascertain the safety profile of barbed sutures in oral and maxillofacial surgery. Therefore, a prospective longitudinal randomized, open-label study was conducted to monitor and compare the adverse effects of unidirectional resorbable barbed and poliglecaprone 25 continuous sutures used for the intraoral surgical incision closure.

Materials and Methods

A total of 70 patients aged between 18 and 45 years undergoing transalveolar extraction of impacted mandibular third molar tooth, open reduction internal fixation of the mandibular fracture, and cyst enucleation in the maxillo-mandibular region requiring the closure of intra-oral surgical incisions longer than 2 cm with the surgical site free of infection were included in the study. The sample size was calculated using assumptions based on a previous study with alpha as 0.05 and power of study as 0.80.[15] Patients having a history of diabetes mellitus, immunocompromised state, pregnancy, lactation, and use of immunomodulatory drugs and oral contraceptive pills were excluded from the study. The study was carried out in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) after Institutional ethical committee approval (vide letter no. LHMC/ECHR/2018/95T). Informed written consent was obtained from all the study participants.

Patients were randomized using sealed envelopes to receive either unidirectional barbed or poliglecaprone 25 suture for intraoral incision closure, placed continuously. Procedures were carried out by an oral and maxillofacial surgeon under local anesthesia using lignocaine (2%) with adrenaline (1:2,00,000). Patients were followed up postoperatively on days 1, 3, 7, and 15 for any suture-related complications or adverse events. Data were presented in frequency and proportions. The difference in the frequencies of adverse events in both arms was compared using the two-tailed Fisher's exact test. Causality association (not-related, possible, probable, and causal relationship) between the use of sutures and the occurrence of adverse events was assessed using the European Commission directives on safety reporting of medical devices in clinical investigations (2020).[16] P < 0.05 and a confidence interval of 95% were considered statistically significant. Statistical analysis was carried out using the IBM Statistical Package for Social Sciences software for Windows PC-version 20.0 (Chicago, USA).

Results

A total of 70 patients were operated on for either transalveolar extraction of impacted mandibular third molar tooth (85.71%), mandible fracture open reduction internal fixation (10.38%), maxillomandibular cyst enucleation (2.59%). Of these, 64 patients completed the study follow-up. The distribution of diagnosis was uniform in both groups (P > 0.05) [Table 1].{Table 1}

The number of adverse events recorded was numerically higher (P = 0.78) with poliglecaprone 25 sutures. Overall, a total of 18 out of 64 (28.125%) patients reported suture-related adverse events in both groups. Suture extrusion and suture discomfort were observed with barbed suture application. Whereas knot unraveling and suture discomfort were observed with poliglecaprone 25 suture use. Suture extrusion was observed in seven patients (21.875%) who received barbed sutures, but was not observed in those who received poliglecaprone 25 sutures. Two patients (6.25%) in the poliglecaprone 25 suture arm exhibited knot unraveling as compared to the other arm. Three patients (9.375%) in the barbed suture group and six patients (18.75%) in the poliglecaprone 25 suture group experienced suture discomfort (P = 0.47) [Table 2]. The causality assessment of suture discomfort with both types of sutures was probable. Suture extrusion was probably associated with the application of barbed sutures. Knot unraveling was possibly related to the poliglecaprone 25 suture. No serious adverse device events were observed in either of the groups.{Table 2}

Discussion

In our study, suture extrusion was observed in 7 (21.87%) patients in the barbed suture group, whereas it was not seen in patients who received nonbarbed sutures. The association of suture extrusion with barbed suture was probable [Table 2]. Grigoryants and Baroni (2012) also reported extrusion following barbed suture use.[17] Rubin et al., in a multicentre RCT, analyzed the outcomes of barbed suture application for dermal closure in abdominoplasty, mastopexy, and reduction mammoplasty, and reported suture extrusion without purulent discharge or abscess as the most common adverse event (20%).[18]

Suture extrusion with barbed suture could be due to the lack of counterbalancing force being applied on the suture line.[19] Preferring bidirectional barbed suture or going back across the incision with the suture a couple of times can minimize extrusion as it locks the tissue bidirectionally.[18] It is advocated that using sutures with shorter and stiffer barbs, having dual-angle geometry, with 20 barbs/cm and one helix/1.52 mm, may minimize tissue micro-slippage.[20] Whereas continuous nonbarbed suture holds the tissue with knots, thus usually not associated with suture extrusion. A recent meta-analysis of randomized clinical trials concluded that barbed sutures lead to heterogeneous postoperative adverse events, attributed to increased risk of inflammation around the barbs.[21]

In this study, knot unraveling was observed in only two (6.25%) patients in which nonbarbed suture was applied. Possibly, the monofilament character and shape memory of nonbarbed suture, resulted in knot slippage and unraveling. An increased number of knots securing the suture and the natural learning curve of the surgeon may reduce this complication. This adverse event was inherently absent with barbed suture application due to the lack of requirement of knots.

The suture-related discomfort experienced by the patients was comparable (P = 0.47) in both arms. This could probably be attributed to the presence of knots that act as a nidus for the entrapment of food debris, causing intra-oral discomfort and irritation at the surgical site.

In this study, the overall safety of barbed sutures was comparable with that of poliglecaprone 25 sutures for intraoral incision closure in oral and maxillofacial surgeries, owing to the minor nature of adverse events. Therefore, barbed suture application may be considered safe in intra-oral surgical procedures requiring flap proximation.

Conclusion

The application of barbed suture for intraoral incision closure was associated with minor adverse events, i.e., suture extrusion and discomfort. Whereas knot unraveling and suture discomfort were associated with the use of nonbarbed sutures. The use of both types of surgical sutures is safe in oral and maxillofacial intraoral incision closure.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References

1	World Health Organization – Uppsala Monitoring Centre. WHO Programme for International Drug Monitoring; 2021. Available from: https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/. [Last accessed on 2021 Oct 01].
2	World Health Organization. WHO Expert Committee on Biological Standardization; 2021. Available from: https://www.who.int/biologicals/expert_committee/en/. [Last accessed on 2021 Oct 01].
3	World Health Organization-Vaccine Safety Advisory Committee. Macrophagic myofasciitis and aluminium-containing vaccines. Wkly Epidemiol Rec 1999;74:337-40.
4	World Health Organization. Medical device regulations: global overview and guiding principles; 2003. Available from: https://apps.who.int/iris/handle/10665/42744. [Last accessed on 2021 Oct 01].
5	World Health Organization. Health Products and Policy Standards: Medical Devices; 2021. Available from: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices. [Last accessed on 2021 Oct 01].
6	Saaiq M, Ahmad S, Zaib S. Neonatal burn injuries: An agony for the newborn as well as the burn care team. Ann Burns Fire Disasters 2013;26:175-81.
7	Abboud L, Ghanimeh G. Thermal burn in a 30-minute-old newborn: Report on the youngest patient with iatrogenic burn injury. Ann Burns Fire Disasters 2017;30:62-4.
8	Chaljub G, Kramer LA, Johnson RF 3^rd, Johnson RF Jr., Singh H, Crow WN. Projectile cylinder accidents resulting from the presence of ferromagnetic nitrous oxide or oxygen tanks in the MR suite. AJR Am J Roentgenol 2001;177:27-30.
9	Patel HC, Mariani JA. An overlooked case of pacemaker-related heart failure. Echo Res Pract 2017;4:K57-60.
10	Chan T, Brady W, Harrigan R. Diagnosis: Pacemaker failure to capture. Emerg Med News 2007;29:11.
11	U.S. Food and Drug Administration. Medical Device Recalls. 2021. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?start_search=1&event_id=51049. [Last accessed on 2021 Oct 01].
12	Quill™ Synthetic Absorbable Barbed Suture, Authors. 510(k) Summary; 2004. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042075.pdf. [Last accessed on 2021 Oct 01].
13	Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: An evaluation of safety and clinical outcomes. JSLS 2010;14:381-5.
14	Al-Mubarak L, Al-Haddab M. Cutaneous wound closure materials: An overview and update. J Cutan Aesthet Surg 2013;6:178-88.
15	Arslan M, Tuncel A, Aslan Y, Kozacioglu Z, Gunlusoy B, Atan A. Comparison of the urethrovesical anastomoses with polyglecaprone (Monocryl®) and bidirectional barbed (V-Loc 180®) running sutures in laparoscopic radical prostatectomy. Arch Ital Urol Androl 2014;86:90-4.
16	MDCG 2020-10/1 Safety Reporting in Clinical Investigations of Medical Devices Under the Regulation (EU) 2017/745. Regulation (EU) 2017/745; 2020. Available from: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf. [Last accessed on 2021 Oct 01].
17	Grigoryants V, Baroni A. Effectiveness of wound closure with V-Loc 90 sutures in lipoabdominoplasty patients. Aesthet Surg J 2013;33:97-101.
18	Rubin JP, Hunstad JP, Polynice A, Gusenoff JA, Schoeller T, Dunn R, et al. A multicenter randomized controlled trial comparing absorbable barbed sutures versus conventional absorbable sutures for dermal closure in open surgical procedures. Aesthet Surg J 2014;34:272-83.
19	Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol 2010;3:82-91.
20	Zaruby J, Gingras K, Taylor J, Maul D. An in vivo comparison of barbed suture devices and conventional monofilament sutures for cosmetic skin closure: Biomechanical wound strength and histology. Aesthet Surg J 2011;31:232-40.
21	Lin Y, Lai S, Huang J, Du L. The efficacy and safety of knotless barbed sutures in the surgical field: A systematic review and meta-analysis of randomized control edtrials. Sci Rep 2016;6:23425.