Abstract
Background/Objectives
To determine whether the success and complication rates of the Lateral Tarsal Strip (LTS) Procedure, when treating involutional ectropion/entropion, is influenced by the use of suture when attaching the tarsal strip to the periosteum.
Subjects/Methods
Multi-centre retrospective comparative study of re-operation and complication rates (Recurrence, Dehiscence, Suture Infection, Granuloma, Haemorrhage, Residual-Lid Laxity, Suture Extrusion and Repeat Procedure) in LTS, between 01/01/2017 and 01/01/2022 who met the inclusion/exclusion criteria, for involutional ectropion/entropion using an absorbable polyglactin (vicryl) and non-absorbable polypropylene suture (prolene).
Results
1079 operations in 891 patients (36% female, average age 81.4 years) were performed with an average follow-up of 1.785 years. 588 operations in 475 patients were performed using prolene whilst 491 procedures in 416 patients were performed using vicryl sutures. Of these, 61% were performed by a consultant surgeon in the prolene group compared to 49.7% in the vicryl group. Overall complication rates between prolene and vicryl were 24.7% and 29.7% (p = 0.061) respectively. Higher complication rates for post-operative residual lid laxity, granuloma and suture infection were greater in the vicryl group versus prolene (2.65% and 0.51% p = 0.004, 2.24% and 0.68% p = 0.03, 1.83% and 0.17% p = 0.007 respectively). Non-significant results for dehiscence or repeat procedures (2.24% and 2.21% p = 0.974, 6.72% and 9.01% p = 0.166 respectively).
Conclusions
Both sutures are effective for the correction of involutional ectropion/entropion with LTS. Dehiscence and redo rates were not statistically significant. Nevertheless, the use of vicryl suture was found to be associated with a higher complication rate for: post-operative residual lid laxity, granuloma and suture infection.
Subject terms: Anatomy, Medical research
Introduction
Involutional ectropion and entropion repair are the two most common oculofacial conditions treated by oculoplastic surgeons in the United Kingdom [1]. A key element of the pathogenesis, behind both aetiologies, is thought to be related to horizontal lid laxity contributing to instability [2]. Whilst there is no consensus on the surgical management of either condition, it is well understood that managing horizontal instability is an important consideration. However, a survey of oculoplastic surgeons in the United Kingdom performed by Mcveigh et al. found LTS and LTS with an adjunct procedure (e.g. Jones plication or Quickert Sutures), to be the commonest surgical treatment for ectropion and entropion respectively [1]. Consequently, the LTS has become the workhorse of the oculoplastic surgeon and the procedure is also commonly performed by the general ophthalmologist extending its relevance [3]. At present, there is no consensus on the material used for the suture, in the key step, where the tarsal strip is attached to the periosteum. This is currently left to the discretion of the surgeon. Both absorbable and permanent sutures have been identified in the literature, of which vicryl and prolene tends to be popular each with their suggested advantages and limitations [4–7]. There is very little published evidence directly comparing two types of sutures, as a primary outcome, in LTS and whether one suture confers an advantage over the other. This is the first study, to the authors’ knowledge, comparing the success and complication rates of absorbable polyglactin (5–0 Vicryl® Polyglactin 910; Ethicon, Inc., Somerville, NJ, USA) suture versus non-absorbable polypropylene suture (5–0 Prolene® Polypropylene; Ethicon, Inc., Somerville, NJ, USA) in the Lateral Tarsal Strip procedure over a five year period.
Materials/subjects and methods
This study is a retrospective multi-centre comparative study of patients undergoing primary Lateral Tarsal Strip (LTS) Procedure, with a nonabsorbable polypropylene suture (prolene) and an absorbable polyglactin sutures (vicryl) to correct lid laxity for ectropion or entropion. The Study evaluated procedures performed over a five-year period from: 01/01/2017 to 01/01/2022 across two National Health Service Trusts: Gloucestershire NHS Foundation Trust and Southend and Orsett NHS Foundation Trusts. Procedures were performed by surgeons, as evaluated by our oculoplastic team, who had the requisite skills, experience and ability to perform LTS independently and successfully.
Operations were performed, for Lateral Tarsal Strip as per the standard approach described in The Colour Atlas of Ophthalmic Plastic Surgery by Collins and Tyers. This involves, fashioning a tarsal strip and attaching it to the periosteum at Whitnall’s tubercle.
Data was collected using The Medisoft audit tool and the Saphire, Medway data capture tool. They were used to identify all patients having undergone a Lateral Tarsal Strip Procedure between: 01/01/2017 to 01/01/2022. The electronic and paper notes were evaluated for each patient to ensure correlation with data capture. Data capture included: surgeon, hospital trust, hospital number, date of procedure, type of procedure, suture type, past medical history and complications (recurrence, dehisence, suture infection, granuloma, haemorrhage, lid lxity/undercorrection, suture extrusion and repeat procedure). Inclusion criteria were: lateral tarsal strip procedures with appropriate adjunct procedures (medial spindle, retractor plication, everting sutures) to correct lid laxity. All patients under the age of 18 were excluded, all procedures that had previous lid surgery affecting the lower lid were excluded, aetiologies other than involutional entropion or ectropion were excluded. Surgeons not deemed to be independently competent in the procedure, as evaluated by the oculoplastic team, were excluded. Any LTS procedure performed with non-approved adjunct procedures were excluded. Each side, for bilateral surgery, was counted individually. Any patients with a follow up less than three months were excluded (either deceased or did not attend and could not be contacted).
A minimum post operative period of one year was intended for all participants. This was performed via an assessment through previous retrospective notes, in-person evaluation, or virtual assessment utilising structured pro-forma to evaluate post-operative complications.
As a retrospective chart review with any further assessment forming part of the patient’s routine follow-up, ethics approval was not required. The study was conducted in accordance with the tenets of the Declaration of Helsinki.
Statistical analysis
Analysis was performed using SPSS V.24.0 (IBM SPSS Statistics for Macintosh).
For the purposes of description and analysis the procedures were divided into two groups: those performed with vicryl suture and those performed with prolene suture. Key demographic indicators that could influence the results such as age and gender were also evaluated for significance between the two groups.
As the data being assessed were categorical, normality was not required to be evaluated. Groups were compared using Pearson’s Chi-Square or Fisher’s Exact Test. When a variable was <5, Fisher’s Exact Test was performed for comparison between groups. P values of ≤0.05 were considered statistically significant.
Results
Overall patient demographics
1079 operations in 891 patients were performed that met the inclusion and exclusion criteria. In the patient population, 94.1% (839/891) of patients were of a Caucasian ethnicity with an average patient age of 81.4 (range 30–99). 36.3% (324/891) of the patients were female. The percentage of patients with a co-morbidity of anticoagulation/antiplatelets, diabetes or immunosuppression were 23.5% (209/891), 16.2% (144/891) and 5.9% (53/891) respectively. 62.0% (669/1079) of the primary operated aetiology were ectropion repair and 56.0% (604/1079) of patients were performed by a consultant surgeon with an average follow up period of 1.785 years (Table 1).
Table 1.
Complication rates of vicryl versus prolene when performing LTS.
| Suture | ||||
|---|---|---|---|---|
| Prolene (%) | Vicryl (%) | Total N (%) | P value | |
| Total procedures | 588 | 491 | 1079 | |
| Complication | 167/588 (28.40) | 144/491 (29.3) | 291/1079 (26.97) | 0.738 |
| Recurrence | 56/588 (9.52) | 32/491 (6.52) | 81/1079 (7.51) | 0.072 |
| Dehisence | 13/588 (2.21) | 11/491 (2.24) | 25/1079 (2.32) | 0.974 |
| Suture infection | 1/588 (0.17) | 9/491 (1.83) | 10/1079 (0.93) | 0.007 |
| Granuloma | 4/588 (0.68) | 11/491 (2.24) | 15/1079 (1.39) | 0.030 |
| Haemorrhage | 1/588 (0.17) | 3/491 (0.61) | 4/1079 (0.37) | 0.336 |
| Lid laxity/Undercorrection | 3/588 (0.51) | 13/491 (2.65) | 16/1079 (1.48) | 0.004 |
| Suture extrusion | 1/588 (0.17) | 0/491 (0.00) | 1/1079 (0.09) | 1.000 |
| Repeat procedure | 53/588 (9.01) | 33/491 (6.72) | 83/1079 (7.69) | 0.166 |
Bold values represent values that are statistically significant.
Subdivided vicryl and prolene patient demographics
491 operations in 416 patients were performed using absorbable 6–0 Coated Vicryl® polyglactin 910 sutures to attach the tarsal strip to the periosteum. Whilst 588 operations in 475 patients were performed using non-absorbable 5–0 Prolene® Polypropylene suture.
In the vicryl cohort, 99.8% (415/416) of patients were of a Caucasian ethnicity and 34.1% (142/416) female compared to 89.3% (424/475) and 38.3% (182/475) in the prolene cohort respectively (p < 0.05 and p = 0.196). The average patient age in the vicryl group was 80.4 years (range 34–97) compared to 82.3 in the prolene group (range 30–99 p < 0.05). In the vicryl contingent, 74.5% (366/491) of the primary aetiology was ectropion repair and 49.7% (244/491) of all procedures were performed by a consultant compared to 51.5% (303/588) and 61% (360/588) in the prolene contingent respectively (p < 0.05 and p < 0.05). The percentage of patients with a co-morbidity of anticoagulation/antiplatelets, diabetes or immunosuppression were 23.8% (99/416), 16.8% (70/416) and 3.4% (14/416) respectively in the vicryl cohort compared to 23.2% (110/475), 15.6% (74/475) and 8.2% (39/475) respectively in the prolene cohort (p = 0.547, p = 0.421 and p = 0.004). The average follow up period was 1.62 years (range 0.25–5) for vicryl and 1.95 years for prolene (range 0.25–5) (Table 1).
Overall complication rates
The overall complication rate was found to be 26.97% (291/1079) in all procedures. Complications were: recurrence (7.51% 81/1079), dehiscence (2.32% 25/1079), suture infection (0.93% 10/1079), granuloma (1.39% 15/1079), haemorrhage (0.37% 4/1079), lid laxity/under correction (1.48% 16/1079), suture extrusion (0.09% 1/1079) and repeat procedure (7.69% 83/1079) (Table 2).
Table 2.
Patient demographics, characteristics and follow up times.
| Suture | ||||
|---|---|---|---|---|
| Patient and procedure characteristic | Prolene (%) | Vicryl (%) | Total N (%) | P value |
| Average patient age (years) | 82.3 | 80.4 | 81.4 | 0.000 |
| Caucasian patients | 424/475 (89.3) | 415/416 (99.8) | 839/891 (94.1) | 0.000 |
| Female patients | 182/475 (38.3) | 142/416 (34.1) | 324/891 (36.3) | 0.196 |
| Primary aetiology: ectropion | 303/588 (51.5) | 366/491 (74.5) | 669/1079 (62.0) | 0.000 |
| Procedures performed by consultant | 360/588 (61) | 244/491 (49.7) | 604/1079 (56.0) | 0.000 |
| Immunosupressed patients | 39/475 (8.2) | 14/416 (3.4) | 53/891 (5.9) | 0.004 |
| Diebetic patients | 74/475 (15.6) | 70/416 (16.8) | 144/891 (16.2) | 0.421 |
| Patients on anticoagulants/antiplatlets | 110/475 (23.2) | 99/416 (23.8) | 209/891 (23.5) | 0.547 |
| Follow up period | 1.95 years | 1.62 years | 1.785 years | N/A |
Bold values represent values that are statistically significant.
Subdivided vicryl and prolene complication rates
The overall complication rate in the vicryl cohort compared to prolene was found to be 29.30% (144/491) and 28.40% (167/588) respectively (p = 0.738).
Recurrence and dehiscence rates for vicryl were 6.52% (32/491) and 2.24% (11/491) respectively compared to prolene which were 9.52% (56/588) and 2.21% (13/588) respectively (p = 0.072 and 0.974). Suture infection and granuloma rates for vicryl were 1.83% (9/491) and 2.24% (11/491) respectively compared to prolene which were 0.17% (1/588) and 0.68% (4/588) respectively (p = 0.007 and 0.03). Haemorrhage rates for vicryl were 0.61% (3/491) compared to prolene which were 0.17% (1/588) (p = 0.336). Lid laxity/under correction and repeat procedure required for vicryl were 2.65% (13/491) and 6.72% (33/491) respectively compared to prolene which were 0.51% (3/588) and 9.01% (53/588) respectively (p = 0.004 and 0.166). Finally suture extrusion rate for vicryl was 0.20% (1/491), compared to prolene which was 0.17% (1/588) (p = 1.000) (Table 2 and Fig. 1).
Fig. 1. Complication rates of vicryl compared to prolene suture when performing LTS.
This is a graphical representation comparing complication rates of vicryl and prolene suture in LTS. The y-axis details the type of complication with the x-axis outlining the percentage of each complication. Green bars constitute prolene suture and blue bars constitute vicryl. The darker bars represent statistically significant results, whilst the lighter bars represent non-statistically significant results.
Discussion
The LTS is a procedure that the general ophthalmologist is expected to show competence in due to its versatility in correcting horizontal lid laxity, a key pathophysiologic feature, in both ectropion and entropion aetiologies [2, 3]. Other techniques including: Wedge Resection, Bick’s procedure and Canthal Plication have also been cited in the literature and are often used to address horizontal lid laxity [8, 9]. However, the LTS remains the most common surgical treatment for both aetiologies perhaps due to the relative simplicity of the operation, its ability to avoid lid notching and directly correcting the underlying anatomical abnormality by fixating the canthal tendon to the orbital rim [10].
This has resulted in the LTS becoming one of the most common oculoplastic procedures performed in the United Kingdom and internationally [1, 3]. Studies evaluating, other oculoplastic surgeries have found differences in outcomes and complication rates when comparing non-absorbable versus absorbable suture types on their patient populations [11, 12]. Despite this, a review of the literature shows very little inquiry into the impact of suture material on complication rates and outcomes of LTS surgery. A study by Clauss et al. reported on the differences in complication rates between vicryl or mersilene as a secondary outcome measure in LTS. The primary outcome measure in this study was the assessment of LTS, with and without conjunctival stripping. The study was also limited by a minority of complications being reported from a small sample of only 239 cases with an average follow up time of 53.8 weeks [13]. We report on a large multi-centre study evaluating the complications and outcomes in LTS surgery of a commonly used absorbable suture (5–0 Vicryl® Polyglactin 910; Ethicon, Inc., Somerville, NJ, USA) and non-absorbable suture (5–0 Prolene® Polypropylene; Ethicon, Inc., Somerville, NJ, USA) over a five year period.
Residual lid laxity
Our study did not show a statistically significant difference in overall complication rates between prolene (28.40%) and vicryl (29.3%) Suture when performing LTS (p = 0.738). However, a statistically significant increased risk of post-operative residual lid laxity, not sufficient to cause recurrence of the lid malposition, was identified in the vicryl (2.65%) group compared to prolene (0.51%) (p = 0.004). As other authors have outlined, attaching the tarsal strip to the periosteum is a critical step [13]. If an adequate fibrotic scar, is not formed between the tarsal plate and periosteum mechanical failure could result. Some surgeons question whether an adequate fibrotic scar can form a strong enough adhesion prior to an absorbable suture such as vicryl losing its tensile strength. This is often the rationale for using a permeant suture [13]. Other authors have also suggested that a permanent suture may provide additional support and scaffold to a fibrotic scar, helping to maintain its longevity by minimising tractional forces [11]. The consequence of Mechanical failure could range from residual lid laxity, to recurrence of the initial aetiology and even dehiscence along a spectrum of severity.
Our study suggests that a mild degree of failure may be present in the vicryl group, due to the statistically significant post-operative residual lid laxity. However, it does not appear to be clinically significant. This is borne out through the data which shows no statistically significant difference in recurrence of the primary aetiology, dehiscence and repeat procedure rates between the two groups. It could be suggested, that in both groups a reasonable degree of adhesion is formed to correct the underlying pathology though in the prolene group the adhesion may be mildly stronger.
It is also interesting to note that despite these findings, prolene had a higher rate of repeat procedure compared to vicryl (9.01% versus 6.72%) though these findings were not statistically significant (p = 0.166). The reasons for repeat surgery were most commonly due to recurrence of the lid malposition. This was not noted in the immediate post-operative period but most often over a year after the initial surgery. The decision to perform a repeat procedure was a function of patient choice, with several patients not wishing to undergo a repeat procedure, individual clinical assessment and symptomatology. The higher repeat procedure rate in the prolene group, could be related to a statistically significant greater number of entropion repairs requiring adjunct procedures e.g. jones plication/ quickerts and thus the failure being a function of both procedures unlike many simple ectropion where only a LTS was required.
Granuloma
We identified a higher risk of granuloma formation in the vicryl group (2.24%) relative to prolene (0.68% p = 0.030) though no difference in wound dehiscence or suture extrusion rates. Another study found a non-statistically significant higher rate of granuloma in another non-absorbable suture (merseline) relative to vicryl [13]. Granuloma formation is thought to occur as a consequence of substantial tissue reaction to suture material [14]. A study evaluating the tissue response to sutures implanted within a rabbit model found an increased tissue reactivity response to absorbable sutures such as vicryl compared to nonabsorbable mono-filament sutures such as prolene. The study also identified a histologically higher number of foreign-body giant cells in vicryl relative to prolene at the tissue interface within the fibrous capsule around each suture. However, this did not prove to be statistically significant [15]. This has also been borne out clinically, where vicryl was found to cause a significantly greater residual wound inflammatory response compared to prolene post Carpel Tunnel decompression surgery [16]. The reasoning behind the intense reaction caused by vicryl is due to an upregulation of pro-inflammatory cytokines relative to anti-inflammatory cytokines reflected in the IL-1β/IL-1RA ratio. Utilising a suture with a weaker inflammatory response, such as prolene, may reduce the chances of granuloma formation [17].
Infection
Rates of post-operative suture infection in the vicryl group (1.83%) were higher than those in the prolene group (0.17% p = 0.007). However, it must be noted that the diagnosis of suture infection was performed clinically; cultures and sensitivities were not taken.
Nevertheless, this is unsurprising considering studies have shown vicryl to have a statistically significant greater propensity for both aerobic and anaerobic bacterial biofilm growth compared to other suture types [9]. It has also been shown that monofilament non-resorbable sutures, such as prolene, possess a clear advantage when minimising bacterial adhesion to their structures [18]. Another study directly comparing vicryl to a number of other suture types, including prolene, found vicryl had a significantly greater bacterial adherence compared to prolene and every other suture tested. Prolene, had the least though this was not statistically significant [19]. The reasoning behind vicryl’s high propensity for post-operative infection is thought to be related to both the chemical structure of the suture and its physical characteristics: including its braided nature and the proprietary weave [9, 18, 19]. The suture’s ability to harbour bacteria despite interventions such as debridement and irrigation may also contribute [19]. Utilising a monofilament, non-absorbable suture material such as prolene may reduce the risk of post-operative suture infection.
Limitations
The study’s conclusions should be interpreted within the context of its methodological limitations. The retrospective, non-blinded nature of the study has inherent weakness in the evaluation and assessment of post-operative complications which could induce a degree of bias. In addition, despite the intention to follow up each subject, for a minimum period of a year, due to a minority of patients being unresponsive or deceased this was not possible to achieve. However, the overall average follow-up period was 1.785 years. Whilst our study was careful to include only those surgeons who had the requisite skills, experience and ability to perform LTS independently and successfully, there was a statistically significant difference in the number of procedures performed by consultants in the Prolene arm compared to Vicryl. As LTS is a generalist procedure, we wished to include a variety of competent surgeons in our sample size to reflect the clinical reality within the health service.
Furthermore, re-operation thresholds may be subject to both patient and clinician variability. Whilst a prospective randomised trial utilising a small number of surgeons may eliminate elements of bias within this study, we feel the cost implications for a similar large multi-centre study with a similar follow up period may be cost-prohibitive.
Conclusion
In conclusion, our study found there was not an overall statistically significant difference in complication rates and re-operation between prolene and vicryl suture when evaluating LTS surgery. Therefore, either suture is a reasonable option when performing LTS surgery. However, prolene suture may be considered in select patient groups when attempting to minimise the risk of granuloma formation, post-operative suture infection and mild post-operative lid laxity.
Summary
What was known before
Vicryl and prolene are some of the most common absorbable and non-absorbable sutures used in LTS respectively.
The type of suture, whether absorbable or non-absorbable, has been shown to influence the outcome and complication rates of different types of oculoplastic surgery.
However, no study is presently available to determine how suture types influences the outcomes, and complications of LTS surgery.
What this study adds
Both vicryl and prolene had dehiscence and redo rates, that were comparable and showed no statistically significant difference.
Nevertheless, we found that the use of vicryl suture was associated with a higher complication rate for: post-operative residual lid laxity, granuloma and suture infection.
Either suture may be used effectively in the correction of involutional ectropion/entropion with LTS. However, prolene suture may be considered in select patient groups when attempting to minimise the risk of granuloma formation, post-operative suture infection and mild post-operative lid laxity.
Acknowledgements
We are grateful to the Ophthalmology departments at both trusts for their support.
Author contributions
All authors have made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or revising it critically for important intellectual content; AND Final approval of the version to be published.
Data availability
Data available, on reasonable request, by contacting the corresponding author.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data available, on reasonable request, by contacting the corresponding author.