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Abstract

Objective: To explore the clinical outcome when biomaterials are used to repair nasal septal perforations. Methods: A total of 12 patients were treated. The nasal septum was dissected via endoscopic approach. A 4 cm × 7 cm biologic graft (Biodesign^® Tissue Graft) was folded to form a double layer, was placed over the perforation, and was affixed into place using suture. Results: Follow-up ranged from 2 to 8 months after the operation. One patient was not completely healed and presented with a remaining defect of about 2 mm × 8 mm in the upper part of the nasal septum. The remaining 11 patients healed completely. Conclusion: Using a biologic graft to repair nasal septal perforations is an easy operation as it prevents the need to take autologous tissue from the patient, allows for a repair to be performed without creating septal flaps, and has good histocompatibility. It is a safe and effective method that can be used clinically.

Keywords

nasal septum nasal septal perforation biologic graft repair

Introduction

Nasal septal perforation is often seen clinically,¹ but the repair operation is technically difficult to perform and the outcomes are typically not successful. In recent years with the continuous improvement of endoscopic techniques, the surgical success rate has increased significantly. However, success rates remain low in cases of large and/or complicated defects.² Since June 2018, our department has used biologic grafts for repairing nasal septal perforations, achieving satisfactory results and greatly reducing the technical difficulty of the operation.

Patients and Methods

Materials and Methods

The Ethics Committee of General Hospital of Xinjiang Military Region has reviewed the proposed use of human subjects in the aforementioned projects. The research plan and other materials submitted comply with the principles of medical ethics and the requirements of Helsinki Declaration. It is recognized that the rights and the welfare of the subjects are adequately protected; the potential risks are outweighed by potential benefits (Ethical Approval No. GHXJMR-EC099). Furthermore, the written consent was informed, and patients provided informed written consent to have data from their medical records used in our research.

Patients and Etiology

From 2018 to 2020, 12 cases of nasal septal perforation were treated with a biologic graft. The patient cohort included 9 males and 3 females whose age ranged from 18 to 64 years. The patients’ average age was 38 years, and the disease had been present for anywhere between 2 months and 8 years. Two cases were of unknown etiology, 1 case was caused by nose picking, 6 cases were caused by nasal cavity surgery, 2 cases were caused by trauma, and 1 case was caused by long-term use of nasal hormones and decongestants. All patients had differing degrees of dryness of the nasal cavity, crusting, headache, nasal congestion, nose bleeding or blood in the mucus, and whistle sounds when breathing.³ Perforation location in the nasal septum varied and the size varied from 5 mm to 20 mm. There were 4 cases with nasal septal deviation, 4 cases with nasal adhesions, 2 cases with sinusitis, and 1 case with nasal neoplasms (specific diseases are shown in Table 1). The preoperative endoscopy and computed tomography scan of 1 patient are shown in Figure 1. Written informed consent was obtained from all patients.

Table 1.

Specific Diseases.

Serial number	Gender	Age	Etiology	Perforation	Surgery date	Surgical procedure (all under endoscopy)	Postoperative follow-up results
1	Female	56	Unknown	5 mm × 5 mm front center	November 20, 2018	Nasal septum correction, nasal septal perforation repair with biologic graft placement	Success
2	Male	37	Unknown	A longitudinal line of perforations can be seen in the middle of the nasal septum measuring 12 mm long and 3 mm wide at its widest point	June 14, 2018	Nasal septal perforation repair with pedicled transfer mucosal flap and biologic graft placement	Success
3	Male	42	Nasal septal surgery	A circular perforation with a diameter of 10 mm can be seen at the front end. The upper ends of the inferior turbinates on both sides adhere to the nasal septum. The middle part of the left inferior turbinate is absent. Gray-white litchi-like masses in bilateral middle nasal passages are present	November 21, 2019	Repair of nasal septal perforation with biologic graft placement, nasal adhesiolysis, bilateral nasal polyp resection, bilateral maxillary sinus opening, and bilateral anterior group ethmoid sinus opening	Success
4	Male	21	Nasal septal surgery	Nasal septal perforation is about 10 mm × 20 mm	June 10, 2020	Nasal septal perforation repair with pedicled mucosal flap of nasal cavity and biologic graft placement	Success
5	Male	20	Nasal septal surgery	There is an oval perforation about 6 mm × 5 mm in the back of the nasal septum	April 23, 2020	Nasal septal perforation repair with biologic graft placement, nasal adhesiolysis	Success
6	Male	43	Nasal trauma	A circular perforation can be seen at the front end of the nasal septum, with a diameter of about 3 mm	May 28, 2020	Nasal septum correction + left nasal base pedicled mucosal flap transfer, nasal septal perforation repair with biologic graft placement	Success
7	Female	23	Nasal septal surgery	The posterior edge of the right inferior turbinate is adhered to the nasal septum. Perforation located in the middle of the nasal septum; the front and back diameter is about 20 mm, the upper and lower diameter is about 10 mm	June 6, 2019	Nasal base mucosal flap transfer, nasal septal perforation repair with biologic graft placement and nasal adhesiolysis	Success
8	Male	25	Nasal trauma	The nasal septum is centered with a large 10 mm diameter perforation in the front	August 21, 2018	Nasal septal perforation repair with creation of nasal mucosa flap and biologic graft placement	Success
9	Male	49	Buckle nose	There is a perforation about 5 mm × 5 mm at the upper end of the anterior middle of the nasal septum	March 6, 2019	Nasal septum correction under nasal endoscopy, nasal septal perforation repair with biologic graft placement, right inferior turbinate internal folding nasal cavity adhesiolysis	Success
10	Male	64	Long-term use of nasal hormones and decongestants	A perforation about 10 mm × 6 mm in size is visible at the front end of the nasal septum	May 8, 2019	Nasal septum correction under nasal endoscopy, nasal septal perforation repair with biologic graft placement, right ethmoid sinus surgery	Success
11	Male	18	Nasal septal surgery	Perforation located in the middle of the nasal septum; the front and back diameter is about 25 mm; the upper and lower diameter is about 10 mm	January 14, 2018	Nasal septal perforation repair with biologic graft placement, left nasal base mucosa flap and enlargement of right maxillary sinus orifice	A defect of about 8 mm × 2 mm remains at the upper end of the nasal septum
12	Female	53	Nasal septal surgery	Two oval perforations with a size of about 15 mm × 10 mm can be seen at the front and back of the nasal septum	March 5, 2020	Nasal septal perforation repair with biologic graft placement, left nasal base mucosal flap	Success

Figure 1.

Preoperative endoscopy and coronary CT scans of nasal septum before the surgery. (a, b) The nasal septum is centered with a large 10 mm diameter perforation in the front by preoperative endoscopy. (c) A large 10 mm diameter perforation in the front of nasal septum by the coronary CT scans before the surgery. White arrow, a large 10 mm diameter perforation; CT, computed tomography.

Surgical Technique

The nasal septum was dissected via endoscopic approach.⁴ A 4 cm × 7 cm biologic graft (Biodesign^® Tissue Graft) was folded to form a double layer, was placed over the perforation with at least a 5 mm overlap, and was affixed into place using suture. In 5 patients, residual nasal septal cartilage was inserted into the graft, which was affixed with suture approximately 5 mm from the edge of the perforation. Three patients with perforations greater than 15 mm underwent the transfer of the left nasal base mucosal flap to repair the left perforation.

Postoperative Treatment

After the operation, the nasal cavity was left open and the nasal cavities on both sides were splinted and then moisturized with silica gel.⁵ Antibiotics were routinely used for 2 days after the operation. The 3 patients with perforations greater than 15 mm were given vasodilators and drugs (sodium aescinate) to improve microcirculation. Silicone sheets were removed after 1 month. All patients routinely used an epidermal growth factor nasal spray (GeneTime, recombinant human epidermal growth factor derivative for external use, liquid) for the first postoperative month. Two to 3 months after the operation, patients were allowed to block the front nostril with a small cotton ball.

A Post Hoc Power Analysis

First, we encoded the description information on gender, age, etiology, perforation, and surgical procedure (all under endoscopy) (1, 2, 3, 4, 5 . . .), and the data are quantified (shown in Supplemental Table 2). Second, descriptive analysis and normality test were carried out on the data (shown in Supplemental Table 3). In view of the results of Shapiro-Wilk test and Kolmogorov-Smirnov test (P < .01), we can carry out the analysis of variance (shown in Supplemental Table 4). According to the results of variance analysis on etiology and perforation items (P < .05), it preliminarily confirmed that post hoc multiple comparative analysis can be available. Because the analysis of variance is significant, we can make a preliminary quantitative analysis of the difference with quantitative analysis of effect (shown in Supplemental Table 5). Based on the aforementioned data of etiology and perforation, we should focus on the analysis results of etiology and perforation in the subsequent postevent analysis.

Next, the results of Bonferroni variance analysis showed that there is no significant difference between gender in the variable etiology without multiple comparisons after the event. Meanwhile, the variable perforation has significant differences between gender (P = .044**), and post hoc multiple comparisons are indispensable (shown in Table 2). Finally, the results of post hoc multiple comparisons showed that: (1) for variable age and surgical procedure, the order of the mean value is: 1.0 > 2.0. There is no significant difference in the overall mean. (2) For the variable etiology, the order of the mean value is: 2.0 > 1.0. There is no significant difference in the overall mean. (3) For the variable perforation, the order of the mean value is: 1.0 > 2.0. There is a significant difference between 1.0 and 2.0. (shown in Table 3).

Table 2.

Bonferroni Variance Analysis.

Factor	Variable value	Sample size	Mean	Standard deviation	F	P
Age	1	5	42.4	16.41	0.573	.456
Age	2	24	36.417	16.016	0.573	.456
	Total	29	37.448	15.952
Etiology	1	5	1.8	0.447	1.877	.182
Etiology	2	24	2.417	0.974	1.877	.182
	Total	29	2.31	0.93
Perforation	1	5	116	86.415	4.455	.044**
Perforation	2	24	53.167	54.831	4.455	.044**
	Total	29	64	64.186
Surgical procedure (all under endoscopy)	1	5	2.2	1.095	1.521	.228
Surgical procedure (all under endoscopy)	2	24	1.708	0.751	1.521	.228
	Total	29	1.793	0.819

Note. The bold value indicates a significant positive correlation between perforation and gender; **: P < .05.

Table 3.

A Post Hoc Multiple Comparisons.

Factor	(I)	(J)	(I) mean	(J) mean	D-value (I-J)	P
Age	1	2	42.4	36.417	5.983	.456
Etiology	1	2	1.8	2.417	–0.617	.182
Perforation	1	2	116	53.167	62.833	.044**
Surgical procedure (all under endoscopy)	1	2	2.2	1.708	0.492	.228

Note. The bold value indicates a significant positive correlation between perforation and gender; **: P < .05.

Results

Follow-up ranged from 2 to 8 months after the operation. One patient was not completely healed and presented with a remaining defect of about 2 mm × 8 mm in the upper part of the nasal septum. This patient had a perforation of more than 20 mm at surgery, presented with an insufficient blood supply at the margins, and received a mucosal flap that did not adequately cover one side of the defect during the procedure. The remaining 11 patients healed completely. Postoperative endoscopies are shown in Figure 2.

Figure 2.

Postoperative endoscopies. (a1, a2) One month after operation, the repaired part of nasal septum perforation was largely epithelialized, but the absorbable thread was still fixed in place. (b1, b2) Two months after operation, the repaired part of nasal septum perforation was completely epithelialized, and most of the absorbable thread was absorbed. (c1, c2) Three months after operation, the mucosa of nasal septum was intact and healed well.

Discussion

Nasal septal perforation refers to the formation of permanent perforations of different sizes and shapes in any part of the nasal septum, such that the 2 sides become connected. The condition is not a clinically uncommon disease.⁶ There are several etiologies for nasal septal perforation including iatrogenic causes, poor lifestyle habits, occupational factors, and trauma.⁷ At present, iatrogenic septal perforation, especially after septum surgery, is the most common etiology.^8,9 Six of the 12 cases in this article were caused by nasal surgery, 2 cases were due to nasal trauma, 1 was a bad lifestyle habit, and 1 was a history of long-term use of nasal hormones and decongestants, which are all the etiologies consistent with other reports.

At present, an important method for the treatment of nasal septal perforation is surgical repair to restore the physiological function and normal shape of the nasal cavity as much as possible.⁶ However, surgical repair is often difficult, and the success rate is low.¹⁰ In addition, there are many different surgical techniques and no clear classification methods. Published articles confuse the surgical repair technique with repair materials, and so it may be useful and appropriate to classify the surgical methods.

Choice of Surgical Approach

Many peer-reviewed publications confuse the repair method of nasal septum perforation with repair materials,^11,12 and there is no clear classification method. The author believes that it is more appropriate to classify the surgical methods as follows based on various theories.

(1) Tension reduction with suture, also known as the displacement suture method¹³; (2) plastic repair method¹³; (3) external sticking method, with or without free tissue flaps or pedicled mucosal flaps; (4) sandwich method, with or without free tissue flaps or pedicled mucosal flaps; and (5) combined use of the aforementioned surgical combinations, such as the nasal cavity pedicled mucosal flap combined with a nasal cavity free tissue flap or an autologous distant free tissue flap, foreign body materials, or artificial or biologic materials. In this article, 4 cases used biologic materials directly (Biodesign^® Tissue Graft), 5 cases used a combined technique with free nasal septal cartilage, and another 3 cases used a combined technique with nasal base pedicled mucosal flap transfer repair, all of which achieved good results.

The pedicled tissue flap in the published literature should belong to the external sticking method category.² As for the compound tissue flap reported in the literature, many authors regard the combined operation as a compound tissue flap, which is a wrong concept.^14,15 The concept of a composite tissue flap refers to a living tissue unit that contains a variety of tissue structures and has its own blood supply. From the perspective of blood supply, composite tissue flaps can be divided into 2 categories: a simple composite tissue flap supported by a single vascular pedicle and a composite tissue flap supported by multiple vascular pedicles. What most authors describe in the literature should therefore be the combined use of various mucosal flaps and free tissue flaps or materials.¹⁶

Selection of Repair Materials

Repair materials used in nasal septal perforation repair can be classified into autologous materials^17,18 (including nasal cavity free tissue flaps, nasal cavity and nearby pedicled mucosal flaps, or autologous distant free tissue flaps), allogeneic materials, and artificial/biologic materials. The specific material classification is shown in Figure 3. The advantages, disadvantages, and application scope of specific materials are shown in Table 4. Among them, a biologic graft¹⁹ is derived from autologous or heterogeneous skin, small intestinal submucosal tissue, or other collagen matrix material. It is decellularized and manufactured to reduce immunogenicity using various treatment methods. The decellularized matrix material retains the 3-dimensional framework of the extracellular matrix, which can support the growth and proliferation of cells, and further promote the adhesion, growth, and proliferation of different cell types in the injured area to repair and reconstruct the defective tissue. The 3-dimensional support structure and the biologic growth factors contained in the extracellular matrix can promote tissue repair, and the released biological signals can promote nerve cell differentiation and vascular regeneration.²⁰

Figure 3.

Selection of different repair materials under different conditions. The repair materials can be classified into autologous materials (including nasal cavity free tissue flaps, nasal cavity and nearby pedicled mucosal flaps, or autologous distant free tissue flaps), allogeneic materials, and artificial/biologic materials.

Table 4.

The Advantages, Disadvantages, and Application Scope of Specific Materials.

Repair materials	Autologous materials			Allogeneic materials	Synthetic and biologic materials
Repair materials	Nasal free tissue flap	Nasal and adjacent pedicled mucosal flap	Autologous distant free tissue flap	Allogeneic materials	Synthetic and biologic materials
Advantages	Easy access to the materials and no rejection	Good blood supply, strong resistance to infection, easy to survive, fast healing and high success rate	No rejection reaction, size optional	Rich source, moderate thickness, not easily deformed, little damage	Good shape, no shrinkage and curl, easy to operate, various sources, can be taken many times and trimmed repeatedly
Deficiencies	The size is limited. However, the single-layer tissue flap repair is not easy to fix, is easy to dislodge, has poor blood flow, is easy to reperforate in the center, and prone to fissure at the edge.	The surgical operation is more complex and with relatively large damage. It is difficult to affix and the margins are prone to fissures and requires second-stage dissection of the tip. The tissue flap of the nasal transfer is limited in size and tension, and the new trauma defect is large, which has the disadvantage of losing both sides.	Poor blood flow and easy to contract and curl. Difficulty in fixing certain materials, adding new trauma and pain to the patient. The repair of perforation by simple grafting of temporalis fascia or broad fascia often fails due to poor blood supply and dry necrosis of the graft.	Possible rejection reaction. Psychological discomfort for patients, ethical clearance required	May have rejection reactions. May cause discomfort in the patient’s nose, easily dislodged, and cause enlargement of the perforation. It should be used with caution in septal perforations due to sarcoidosis and vascular disease, septal perforations with inadequate blood supply at the edge of the perforation, and in those with large perforations.
Indications	Suitable for repairing perforations of less than medium size	Suitable for repairing perforations of less than medium size	Suitable for repairing large perforations	Suitable for repairing large perforations	It is mostly used for those who suffer from vasculitis, are at risk of surgery, and have severe injuries with inadequate blood supply and are not suitable for surgery. For large perforations, posteriorly located, marginal perforations at the base of the septum, and irregularly shaped perforations that are not suitable for surgery, personalized septal prosthesis is often chosen to close the perforations.

We have used a biologic graft material for nasal septal perforation and have found that patient selection and surgical technique are important to achieving good outcomes. (1) Relatively young patients with fast basal metabolism should be selected, because these factors are conducive to rapid tissue reconstruction. (2) While the necrotic tissue and mucosa around the perforation should be excised as much as possible, the mucoperiosteal flaps of the bilateral nasal septum should be separated widely to ensure the fixation of the biologic graft between the mucous periosteum. If necessary, suture fixation can be used to strengthen the repair. (3) The tissue graft can be used to induce the growth of soft tissue in the internal nasal cavity, and successfully reconstruct a perfect autologous soft tissue which can be used to replace the autologous fascia and provide a collagen framework for tissue growth.²¹ In addition, the growth factors contained in the tissue graft can help the newly deposited tissue to quickly vascularize and tolerate infection. (4) For patients with a perforation greater than 1 cm, the graft should be augmented with a mucosal flap, which significantly increases the chance of success. (5) For perforations with a nasal septum of more than 1 cm, the blood supply to the center of the repair becomes a problem,²² causing reperforation as a result of central ischemia. A mucosal flap on 1 side can seal the perforation as much as possible but minimizing the gap to 5 mm or less is more likely to result in a successful outcome and lessen the chances of reperforation. (6) Patients with a perforation area of greater than 2 cm should be chosen carefully due to the increased risk of a recurrent perforation. (7) For patients with severe bilateral mucosal damage during nasal septum surgery, but no mucosal loss, the biologic graft can be directly inserted without flaps.¹³ Doing so will result in good healing, greatly reduce the chance of postoperative perforation, and avoid the pain and expense of a reoperation.

The biologic material used in this study, the Biodesign^® Tissue Graft, has several advantages over other materials. The tissue graft can be used in the internal nasal cavity to induce the growth of soft tissue and remodel into a fully functional autologous soft tissue which can be used to replace the autologous fascia and provide a collagen framework for tissue growth.²³ In addition, the growth factors contained in the tissue graft can help the newly-deposited tissue to quickly vascularize and tolerate infection.¹² For patients with severe bilateral mucosal damage during nasal septum surgery but no mucosal loss, the biologic graft can be directly inserted without flaps.²⁴ The patient’s recovery status is good, which greatly reduces the chance of postoperative reperforation and helps reduce the patient’s pain and expense of reoperation.

In recent years, biologic grafts have been widely used clinically in neurosurgery, orthopedics, dermatology, urology, thoracic surgery, otolaryngology, and head and neck surgery. No obvious side effects of surgery have been found, but there are still risks that have not been assessed.^25,26 The economic cost is relatively high: at present, the 2 cm × 3 cm patch is priced at more than 4000 yuan, and the 4 cm × 7 cm patch is more than 6000 yuan. The economic cost of patients has increased significantly.²⁷ There has been no continuous follow-up to determine long-term success, and no long-term evaluation of whether there are adverse effects on the body, such as the impact on tumors. All these factors need further exploration and study.

Using a biologic graft to repair nasal septal perforations is an easy operation, prevents the need to take autologous tissue from the patient, allows for a repair to be performed without creating septal flaps, and has good histocompatibility.¹³ It is a safe and effective method that can be used clinically.

Limitations of Our Work

Due to limited cases that have been operated on, we did not statistically analyze data on application of biologic graft. Furthermore, continuous follow-up on long-term success and long-term evaluation of whether there are adverse effects on the body should be considered to focus on. Therefore, we will study further these aforementioned issues in our next work.

Supplemental Material

sj-docx-3-ear-10.1177_01455613241233748 – Supplemental material for Application of Biologic Graft in Nasal Septal Perforation Repair

Supplemental material, sj-docx-3-ear-10.1177_01455613241233748 for Application of Biologic Graft in Nasal Septal Perforation Repair by Jianjun Jing, Liang Li, Yongxiang Wu, Liang Zheng, Longfang Zhang, Haihong Li and Hui Wang in Ear, Nose & Throat Journal

Supplemental Material

sj-jpg-1-ear-10.1177_01455613241233748 – Supplemental material for Application of Biologic Graft in Nasal Septal Perforation Repair

Supplemental material, sj-jpg-1-ear-10.1177_01455613241233748 for Application of Biologic Graft in Nasal Septal Perforation Repair by Jianjun Jing, Liang Li, Yongxiang Wu, Liang Zheng, Longfang Zhang, Haihong Li and Hui Wang in Ear, Nose & Throat Journal

Supplemental Material

sj-jpg-2-ear-10.1177_01455613241233748 – Supplemental material for Application of Biologic Graft in Nasal Septal Perforation Repair

Supplemental material, sj-jpg-2-ear-10.1177_01455613241233748 for Application of Biologic Graft in Nasal Septal Perforation Repair by Jianjun Jing, Liang Li, Yongxiang Wu, Liang Zheng, Longfang Zhang, Haihong Li and Hui Wang in Ear, Nose & Throat Journal

Footnotes

Author Contributions

Concept and design: Jianjun Jing and Liang Li; data collection and analysis: Liang Zheng, Haihong Li, and Hui Wang; drafting of the article: Liang Li and Longfang Zhang; critical revision of the article for important intellectual content: Yongxiang Wu; study supervision: Jianjun Jing. All the authors approved the final article.

Data Availability

All data that support the findings of this study are included in this article and its supplementary information files. The datasets used or analyzed during the current study are available from the corresponding author on a reasonable request.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Youth Development Project of Military Medical Science and Technology (MMST, No. 14QNP023). They all authored or reviewed drafts of the article.

Ethical Approval

This study was approved by the Ethics Committee of General Hospital of Xinjiang Military Region (Reference number to the ethical application: GHXJMR-EC099), and the written approval was waived.

ORCID iD

Jianjun Jing

Supplemental Material

Supplemental material for this article is available online.

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Supplementary Material

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