Merocel versus a new septal clip with splint in post septal surgery cases: a prospective study

Abstract


Background
Nasal packing is commonly used to control bleeding following septoplasty.It has been reported to stabilize the remaining cartilaginous septum internally and prevent complications such as septal hematoma and the formation of synechiae.However nasal packing has some inherent disadvantages such as causing pain, nasal mucosal damage, septal perforation, sleep and respiratory disturbances.Patients often consider packing removal to be the most unpleasant experience of their operation and

Methods
The aim of this study was to assess and compare the Merocel ® pack with that of new septal splints with clip-on nasal functions with their eventual effects, complications, and outcomes in the post-operative period.A prospective, comparative, and randomized study was undertaken in a tertiary medical teaching institution in Kolkata, India.The study population was 50 patients, aged between 18 and 50 years irrespective of gender who were diagnosed to have symptomatic deviated nasal septum, and potential surgical candidates were included in the study.Exclusion criteria include patients below 18 years of age, patients who underwent revision surgeries, septorhinoplasty, and septoplasty performed along with endoscopic sinus surgeries and associated sinusitis.Then in all such patients detailed history was taken followed by thorough clinical examinations including anterior rhinoscopy and diagnostic nasal endoscopy using 0° Hopkins rod telescope.Investigations including digital X-ray of paranasal sinuses (PNS) of occipitofrontal view(OM) or plain computerized tomography(CT) scan of PNS were done in each case as well as general investigations for anesthetic workup before surgery.The patients were randomly divided into two groups according to the type of nasal pack they would receive following surgery.Group M constituted 25 patients who had Merocel ® sponge applied after surgeries and group C constituted 25 patients who had septal clips with splints applied after surgeries.In all the cases septoplasty was done under general anesthesia.Probable complications of a packed nose like headache, the need to breathe through the mouth and as a result dryness of the mouth or even dysphagia, pain or pressure in the nose, sleeplessness, and crust formation in nasal cavities resulting sometimes in synechia been explained to all patients undergoing septal surgeries.
Merocel ® (Medtronic Inc., Minneapolis, MN, USA), one of the most common nonabsorbable nasal packing materials, is a compressed, dehydrated sponge composed of hydroxylated polyvinyl acetate that can increase in size within the nasal cavity and compress a bleeding vessel through rehydration with normal saline.Because it is a non-absorbable solid disadvantages of which may include pain and bleeding upon removal, nasal obstruction, and mucosal edema.
The method of introduction is quite simple.First, it is lubricated with antibiotic ointment and then held with Tilley's nasal dressing forceps and inserted along the floor of the nose.It is then inflated by adding 5-10 drops of normal saline.It is usually kept for 48-72 h and then removed (Figs. 1 and 2).
The septal clip with splints (manufactured by Nithya Medical Products, Coimbatore, India) (Fig. 3) is used after septal surgery.The septal clips are made up of stainless-steel wires and splints are made up of polyethylene.The splints have ridges on their lateral and inferior aspect to prevent the clip from sliding down and also to identify the side it belongs to.The two splints are introduced with ridges facing downward and laterally and broad front going posteriorly towards chaona and a narrow tapering end lying anteriorly.Using Tilly's nasal Fig. 1 An unopened Merocel ® sponge pack dressing forceps, the splints are manipulated to pass medial to the middle turbinate.Observe the ridge which acts as a pointer of its side should face infero-laterally (Fig. 4).Position of the surgeon's hand with Tilley's forceps during the introduction of the splint (Fig. 5).Ideal position of bilateral splints in nasal cavities after introduction.Now stainless steel septal clip is introduced by fingers making sure that the ring portion lies anteriorly and the angle between strands and ring faces downwards.A thread is passed into the holes in the anterior part of the splints and tied loosely.(Fig. 6).Then clip is introduced in contact with splints on both sides with the ring facing downwards.The metal clip should not come in contact with septal Mucosa.The clip should be placed at a higher level than the nasal floor.At the end of insertion, a small bolster of gauge piece is placed in front of the columella to prevent injury and subsequent pressure necrosis of columellar skin (Fig. 7) and this together with clip and splints is tied with a 3-0 chromic catgut suture to prevent their relative displacement in immediate postoperative period.No further packing is required by the sides of the splints.Pricewise septal clip with a splint In the postoperative period, all patients were given broad-spectrum intravenous antibiotics, analgesics, antiemetic and decongestant nasal drops.After 6 to 8 h following surgery patients were first assessed and any untoward symptoms were noted.Common features that were seen were pain, watery eye discharge, nasal obstruction, dryness of mouth, sleep disturbance, headache, and postnasal drip.Both Merocel ® and septal splints with clip were removed after 48 h and patients were discharged on the 3rd postoperative day with oral antibiotics, analgesics, nasal decongestants, and normal saline nasal spray.Patients were again studied after seven days of surgery.Common signs found in this period in both groups were nasal crusting, vestibulitis, and septal injuries.Endoscopic cleaning of nasal cavities with clearance of crusts done in all cases 7 days after surgery.Finally, patients were again seen at 1 month and diagnostic nasal endoscopy was performed to assess the status of the septum and the presence of synechiae between the septum and lateral nasal wall if any was recorded.Patients were also asked about their symptomatic improvement.

Results
Our study constituted 50 patients among which 36 were males and 14 were female patients and male to female ratio was 3:1.Our study population includes 25 patients for septal clips and 25 patients for Merocel ® pack.They were assigned randomly into group M for patients who were given Merocel ® pack and group C for patients who were given septal clips with splints after surgery.Among the 25 patients in group M, 17 were male and 8 were female and among 25 patients in group C, 19 were male and 6 were female (Table 1 and Fig. 8).
Statistical analysis was performed by chi-square (χ 2 ) test with the help of Epi Info (TM) 3.5.3.EPI INFO is a trademark of the Centers for Disease Control and Prevention (CDC).Using this software, basic cross-tabulation, inferences, and associations were performed.χ 2 test was used to test the association of different study variables with the study groups.Z-test (standard normal deviation) was used to test the significant difference between the two proportions.t test was used to compare the means.p < 0.05 was considered statistically significant.
Patients were broadly classified into DNS to the right or left side and underwent a septoplasty.The main observations that were found in both groups irrespective of whether Merocel ® sponge or septal clips were applied postoperatively were (1) pain, (2) nasal obstruction, (3) sleep disturbance, (4) headache, (5) watery  discharge from the eye, (6) dryness of mouth, and (7) postnasal drip.Some amount of pain was complained of by 48 out of 50 patients in our study postoperatively.
All 25 patients of group M and 23 patients of group C had pain.Pain scores of the patients belonging to both groups were studied separately using a visual analog scoring system (VAS scale) and tabulated.On a scale of 0 to 10 points are given starting from the left-hand side according to the patient's perception of pain where 0 indicates no pain and 10 indicates the worst pain imaginable for a patient.Score 1, 2, and 3 therefore indicates mild pain, whereas 4, 5, and 6 moderate pain, and 7, 8, 9, and 10 indicate severe pain.The pain was studied 6 to 10 h after the procedure and the mean pain score (MPS) was calculated.It was mild to moderate in the case of group M (MPS was 2.4) and moderate to severe degree in the case of group C (MPS was 5.7) (Table 2).
Nasal obstruction was the second most common symptom immediately postoperatively and was present in all 25 patients with Merocel and 5 patients with septal clip and it was ascertained clinically by fogging during a cold spatula test and studied separately in both the groups by a single examiner.Fogging was absent in all cases of group M and unilaterally absent only in 5 cases of group C (Table 3).This is one of the advantages of the septal clip as the difference was statistically significant (p < 0.05) (Table 3).
Sleep disturbance, headache, watery discharge from the eye, and dryness of mouth were assessed subjectively 6-8 h after surgery specifically asking about these symptoms.All of these were more in group M than group C and the differences were statistically significant (p < 0.05).During examination of the oropharynx postnasal drip (PND)was noted as probably due to mechanical obstruction of anterior sinus ostia due to pack or blood clots and thereby causing obstructive sinusitis resulting in such discharge.PND was more in cases of a clip than Merocel ® because Merocel ® tends to occlude whole nasal cavities and thereby prevents drainage of normal sinus discharge to pass through the oropharynx in most of the cases.This is not so in cases of the clip where only minimum blood clots due to surgery may cause obstruction.This difference between the two groups in our study was statistically significant (p < 0.05).
After 48 h clips and packs were removed and outcomes were studied endoscopically.The main findings observed during this time were (1) nasal crusting (2) septal ulcer and (3) columellar injury.Black crust formation in the nasal cavities was seen to happen more in group C (all 25 cases) than in group M (17 cases) and the difference here was statistically significant (p < 0.05) (Fig. 9).This is due to a snugly fitted Merocel sponge that does not allow crusts to form compared to a clip with splints which keeps nasal cavities patent.Columellar injury (Fig. 10) as evidenced by blackening was seen to occur in 4 cases where clips were applied compared to no cases where Merocel was given postoperatively.Though this difference is insignificant statistically (p > 0.05) this is perhaps due to an improperly applied septal clip where the anterior end of the splints lies a little posteriorly so   that the clip gave pressure over exposed lateral edges of the columella and caused discoloration.Nasal vestibulitis occurred only in 1 case of group C among all patients of the study population.That is again due to the superior border of the splint irritating the vestibule of the nose due to improper application or the small size of the nasal cavity.This is a problem of having only one standard adult size of septal splints with clip and no pediatric size available.In both groups, symptoms and signs were statistically analyzed (Table 4).Table shows frequencies of signs and symptoms in both Merocel ® (M) and septal clip (C) groups whereby postoperative nasal obstruction, sleep disturbance, headache, and watery discharge from eyes were statistically significantly lower in group C whereas postnasal drip and crusting in nasal cavities were significantly more in group C compared to group M.
Endoscopic cleaning of nasal cavities was done on all postoperative noses after 7 days and reassessed.While all patients were assessed once again between 7 days and 1 month postoperatively synechiae between septum and lateral wall was found to occur in 2 cases in group M patients.It is perhaps due to injudicious injuries over the lateral nasal wall during septoplasty though the difference in the incidence in the two groups was statistically insignificant (p > 0.05).
Pricewise it is much cheaper to use a septal clip than Merocel sponge because one set of the septal clip with splint costs rupees 200-300 in Indian currency whereas it costs around rupees 500-1000 for two 8 cm Merocel pieces.Hence this may prove especially beneficial for poor countries like India.

Discussion
Total patients in our study group was 50 out of which 36 were male and 14 were female.Both group M and group C included 25 patients each.In group M, 17 were males and 8 were females.So male: female was 3:1.Out of 50 patients, 35 patients had DNS to the right and 15 patients had DNS to the left.So in our hospital, we get more cases of right-sided DNS than left ones at a particular time span.Out of our 50 patients, all underwent septoplasty either classical one or limited septoplasty by correcting caudal dislocation and septum or by removing spur(s).
In our study most common problem associated with DNS is nasal obstruction.In a study conducted by J.janardhan Rao and his group, it was shown that out of their 100 cases, 74 patients had nasal obstruction as the chief complaint [1].
In our study, nasal obstruction was an important immediate postoperative complaint both after applying the Merocel ® pack or septal clip.In group M 100% of patients had complained of nasal obstruction while in group C only 20% of patients had this complaint.Though the symptom is quite cumbersome for postoperative patients it is quite obvious that Merocel ® causes complete blockage of the nasal cavity but in septal clip leaves some space in the nasal cavity through which air can flow.The nasal blockage was also confirmed qualitatively by the cold spatula test.Fogging was present bilaterally in 80% and unilaterally in 20% of patients of group C, meaning thereby in most patients with septal clips airways were patent while for obvious reasons it was absent altogether in group M. As patent nasal airways help in normal sinus drainage it is more physiological with less chance of obstructive sinusitis.Differences in the percentage of laterality of nasal obstruction could be due to differential accumulation of crusts and secretion in nasal cavities or due to subjective variation among group M patients.Yigito' et al. in their study showed nasal packing causes complete obstruction [2].The third most important postoperative complaint was sleep disturbances.In group M, 92%, and in group C 48% complained of sleep disturbance ranging from inability to fall asleep and frequent awakening at night.Complete blockage of both nasal cavities in group M cause disturbance during sleep because change of habitual respiratory air passages from nose to per mouth which is not the case among patients of group C. Cukurova I et al in their study revealed that complete and bilateral nasal packing causes a decrease in nocturnal PaO2 leading to obstructive sleep apnoea.[3].
In group M, 84% of patients complained of headache and in group C 32% also had this complaint.Basavaraj et al in their study showed postoperative headache in 79.3% of patients undergoing septoplasty using nasal packs postoperatively [4].
Forty-four percent of patients complained of watery discharge from eyes in group M while in group C no patient complained of such a thing.In group M patients probably it is due to blockage and pressure over the lateral nasal wall causing functional nasolacrimal duct obstruction whereas in patients for whom septal clips were applied postoperatively nasal passages were clear and lateral nasal walls remained free from any pressure hence no such complaints.In a study conducted by Maria Teresa Bernado et al. 45% of patients with nasal packing had epiphora due to lacrimal duct obstruction [5].
Dryness of mouth was a complaint of 100% of patients in group M but there was only one patient (4%) in group C to complain such a thing.Complete nasal blockage in the Merocel ® group makes patients obligatory mouth breathers which leads to dryness of mouth.Wadhera et al. showed dryness of mouth in their study [6].
Dysphagia was the complaint of 48% of patients in group M and 20% of patients in group C. In group M, the patient has to do mouth breathing but during swallowing of food, he has to stop mouth breathing which is a discomfort for him.Awanms and Iqbal M in their study showed that patients with nasal packs developed dysphagia [7].
Sneezing and itching are two complaints that were more common in group M than in group C. Blockage of the nose causes reflex sneezing.Rajashri et al in their study revealed that the anterior nasal pack causes postoperative sneezing [8].
While all symptoms are more in group M than group C, post-nasal drip was more in group C (64%) as opposed to 12% of patients of group M as the nose is not completely blocked in group C, postoperatively nasal secretion will trickle down along the posterior pharyngeal wall.
The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921 [9] scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm) [10].Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain.The values can be used to track pain progression for a patient or to compare pain between patients with similar conditions.In addition to pain, the scale has also been used to evaluate mood, appetite, asthma, dyspepsia, and ambulation [11].Although there is conflicting evidence with regard to the advantage of the VAS compared with other methods for recording pain, it is still commonly used in clinical and home settings [11,12].Pain related to the nasal pack may be related to the duration of the pack in the nose.In our study pack was removed after 48 h.Pain for this initial 48 h of packing was taken into account.It was found that in both cases pain was more in group M than in group C. In a study done by Acioglu et al., they also found that pain is more in the case of complete nasal packing [13].
Baklaci D et al. conducted one study whereby the authors compared trans-septal suturing technique (TTS) with three other packing materials in post-septoplasty cases and found that postoperative pain including that on removal, pressure, dysphagia, and synechia formation was significantly higher in Merocel [14].In our study pain and dysphagia were more with Merocel but synechia formation was more prevalent with septal clip with splint.
After pack removal anterior rhinoscopy was done on the 7th postoperative day to see crusting, septal ulcer, and vestibulitis.Crusting was higher in group C (100%) in comparison to group M (68%) which is due to the effect of dry air current and decreased mucociliary clearance.This is in contrast to the study conducted by Arora P et al where crusting was more common in the case of anterior nasal packing and found in 6(30%) patients and in no patients where quilt stitching or splints were used postoperatively.[15].
Twenty-five percent of the patients had septal ulcers while it was absent in Merocel group.This ulcer may occur due to the pressure of the splint on the septum.
One patient in group C developed postoperative vestibulitis which may be due to injury caused by a splint on the vestibule.(blackish discoloration).
Two patients develop synechiae after clip removal which may be due to the fact that the splint if not placed properly folds in itself and injures mucosa.The lateral and medial wall of the nose gets adherent to each other and synechiae develops.Though the difference in the formation of synechia in the septal clip group with that of Merocel ® is not statistically significant in our study this is in contrast with the findings obtained in a study by Kim S J et al. [16].In a study by Arora P et al., synechia was more in the packing group though that was not statistically significant [15].
One patient develops a septal hematoma.The reason is that the clip if applied tightly causes local bleeding and septal hematoma.

Conclusion
We observed that Merocel ® nasal packing causes significant morbidity and discomfort in the immediate postoperative period as compared to septal clips.It is also expensive.So, the septal clip with splints can be used as an effective alternative to Merocel ® .
The limitation of such a study is not only that such a septal clip with a splint is not available on a widespread scale because it is proprietary to a single firm.Also, there are several nasal packing materials available but this study focuses only on comparing the more widely used Merocel ® tampoon with that of a new septal clip with a splint which keeps nasal cavities open even after surgery thereby with fewer complications.Our journey henceforth continues from "pack" to "no packs" after any nasal surgeries.A bigger sample size in future such study would be helpful to reach a more concrete conclusion regarding the necessity of nasal packs at all or not after septal surgeries.

Fig. 8
Fig. 8 Composite bar diagram showing male: female ratio of both Group C and Group M

Fig. 9 Fig. 10
Fig. 9 Crusts in nasal cavities after removal of septal clip and splints Page 2 of 9 Das and Ghosh The Egyptian Journal of Otolaryngology (2024) 40:86 usually become very apprehensive of hearing.Attempts have been made to produce materials that will solve these problems.There are a variety of nasal packing materials available nowadays.The type of packing chosen by a surgeon depends on prevailing practice and availability of material.It also depends on the preference and experience of the surgeon.Commonly used materials for packing include (1) Ribbon gauze which consists of open mesh cotton as carrier material with paraffin and antibiotic cream.(2) Merocel ® sponge.(3) Fingerstall pack made of latex rubber packed with foam.(4) Commercially available septal clip with splints.Most of the available packs block the nasal airways and cause some amount or more discomfort to the patients.A quest to reduce this discomfort, a new material called 'septal clips with splint' was tried after septal surgeries which potentially keeps the airways open and it was compared with the most widely used Merocel ® nasal sponge in terms of effects and complications.There are several literatures comparing different types of nasal packs after nasal septal surgery with intranasal splint but none compared this new type of septal clips splint that we used specifically with the Merocel ® tampon that is most widely used in this region of India.

Table 1
Sex ratio in both groupThe above table shows the overall male:female ratio of the patient being 3:1

Table 2
Pain score (visual analog scale) in both groupThe mean pain score was 2.4(mild to moderate) in the case of group M and 5.7 (moderate to severe) in the case of group C

Table 3
Fogging in cold spatula test

Table 4
Symptoms and signs in the study group