|Year : 2019 | Volume
| Issue : 2 | Page : 120-123
Prevention of oronasal fistula in primary palatoplasty with acellular dermal matrix
Adrian Sanchez Balado, Maria Teresa Fernandez Diez, Mauricio Fernando Umaña Ordoñez, Elena Lorda Barraguer
Department of Plastic Surgery, University Hospital of Alicante, Alicante, Spain
|Date of Web Publication||7-Aug-2019|
Dr. Adrian Sanchez Balado
Department of Plastic Surgery, University Hospital of Alicante, Alicante
Maria Teresa Fernandez Diez
Source of Support: None, Conflict of Interest: None
Palatal fistula after primary palatoplasty remains one of the most difficult complications that plastic surgeons have to face. Once the fistula has developed, the complexity of the reconstruction increases significantly, and the revisional surgery results are not promising. The recent use of acellular dermal matrix (ADM) provides a new perspective for the reconstructive surgeon. Our goal is to reduce and prevent the postoperative oronasal fistula in patients with cleft palate by placing an ADM in the zone 3 and 4 of Pittsburgh (hard palate and hard–soft palate junction), creating an extra layer for support of the cleft palate. Seven children diagnosed of palatal cleft with high risk of developing oronasal fistula were operated. The technique of choice was two-flap palatoplasty with lateral incisions and intravelar veloplasty and three-layered closure with ADM in the hard palate and hard–soft palate junction. One patient developed a 3-mm oronasal fistula at 3-month follow-up, with spontaneous closure at 12 months. The rest of the children had an uneventful evolution. Our rate of postoperative oronasal fistula was 0% at 12 months. The use of ADM in primary palatoplasty had been of great use to prevent complications in high-risk oronasal fistula patients.
Keywords: Acellular dermal matrix, cleft palate, complications, palatal fistula
|How to cite this article:|
Balado AS, Diez MT, Ordoñez MF, Barraguer EL. Prevention of oronasal fistula in primary palatoplasty with acellular dermal matrix. J Cleft Lip Palate Craniofac Anomal 2019;6:120-3
|How to cite this URL:|
Balado AS, Diez MT, Ordoñez MF, Barraguer EL. Prevention of oronasal fistula in primary palatoplasty with acellular dermal matrix. J Cleft Lip Palate Craniofac Anomal [serial online] 2019 [cited 2019 Aug 21];6:120-3. Available from: http://www.jclpca.org/text.asp?2019/6/2/120/264100
| Introduction|| |
Palatal fistula after primary palatoplasty remains one of the most difficult complications that plastic surgeons have to face. The incidence of palatal fistula in literature ranges from 0% to 70%, probably due to different reconstructive techniques, surgeon experience, defect size, Veau type, and patient age.
Once the fistula has developed, the complexity of the reconstruction increases significantly, because of tissue fibrosis and its limited mobility, requiring in many cases a secondary palatoplasty or even mucosal flaps, Z-plasty, or transposition flaps from the alveolar ridge.
Despite the best of the efforts, the recurrence after the secondary procedure is still unacceptable, between 30% and 70%, with the need for more and more interventions.
The recent use of acellular dermal matrix (ADM) provides a new perspective for the reconstructive surgeons. In the last two decades, the pharmaceutical industry has shown a big interest in developing improved skin substitutes, with better tissue compatibility and more resistant and pliable, to be used in different fields of plastic surgery such as breast reconstruction, burns, and craniofacial surgery.
There is currently moderate evidence of the use of ADM in cleft palate. Despite the literature shows promising results in Veau III–IV and clefts >10 mm, there are insufficient data for a formal recommendation.,,
The objective of this study is to reduce the incidence of oronasal fistula with the use of ADM in primary palatoplasty for the prevention of oronasal fistula in high-risk patients: patients with clefts >10 mm, Veau II–IV, narrow palatal shelves, or vertical palatal orientation.
| Materials and Methods|| |
The study was conducted at the Plastic Surgery Department in the University Hospital of Alicante. Between 2017 and 2018, 2 male and 5 female children were included. The mean age was 18.42 months old (range, 17–21 months), with a Veau type distribution as follows: 5 Veau III (71%), y 2 Veau IV (29%). One child was diagnosed of an associated congenital syndrome, patent ductus arteriosus, and his mother was HIV/HVC positive Three patients were Arab, one Caucasian, and three Hispanic. The parents were informed and agreed on the use of ADM. [Table 1] summarizes the main features of the sample.
Two-flap palatoplasty with lateral incisions and intravelar veloplasty with three-layered closure and ADM located in the hard–soft palate junction was performed by the same surgical team. The ADM used was SureDerm (HansBiomed, Korea) [Figure 1], [Figure 2], [Figure 3], [Figure 4].
|Figure 2: Once closed the nasal mucosa, we perform the intravelar veloplasty|
Click here to view
|Figure 3: Before the complete closure of the oral mucosa, we introduce the acellular dermal matrix between the two layers in the hard–soft junction|
Click here to view
|Figure 4: Final 3-layer closure of the cleft. Fibrin glue is used to reinforce the sutures and seal the scars|
Click here to view
We registered 3-, 6-, and 12-month follow-ups for the presence of oronasal fistula. In the event of fistula, the 12-month revision was the deadline for the final decision of revisional surgery or conservative treatment.
| Results|| |
Of all samples, 1 (14%) of 7 patients developed postoperative dehiscence at 3-month follow-up, which was successfully closed with conservative treatment. At 12-month follow-up, none (0%) of the patients had oronasal fistula. There were no major complications in the postoperative period.
| Discussion|| |
Oronasal fistula after primary palatoplasty remains one of the most common complications and a difficult issue the plastic surgeon has to deal with. Success in the first surgical procedure is of utmost importance due to its high incidence, varying from 0% to 70%, with a 10% rate in highly experienced hospitals.
The Pittsburgh fistula classification of oronasal fistula describes seven different types depending on the location. From posterior to anterior, the most frequently seen are in the hard–soft palate junction, corresponding to the zones III, IV, and V, with an incidence higher than 80%.
Surgeon experience, cleft size, high-tension closure, Veau type, and age are the main variables related to high risk of oronasal fistula. Some researchers have shown a higher incidence in adopted patients, probably due to the delay in diagnosis or surgical treatment. In our case, the child was adopted when she was 3 months old, so we consider that this issue would not increase the incidence of postoperative fistula. However, we decided to include it in the sample due to the associated patent ductus arteriosus, sometimes related with syndromic conditions.,,,
Despite the best effort of the surgeon for a complete closure, limited movement of the palatal tissues, tight closure, and some degree of tissue atrophy can lead to an unstable closure which evolves in oronasal fistula.
The main problem is the increasingly surgical complexity for the complete resolution, stepping up the surgical difficulty with redo palatoplasty, facial artery mucosal flaps, tongue flaps, Z-plasty, or even microsurgical flaps, with recurrence rates between 33% and 66%.
Clark et al. in 2003 were the first recommending the use of ADM in primary repair of cleft palate, both for preventing complications after primary palatoplasty and for improving scarring while reducing postoperative fibrosis.
There is an increased risk of oronasal fistula in patients with associated syndromes, cleft >10 mm, Veau III–IV, and hypoplastic palatal tissues. Some authors have advocated for the use of ADM as prevention with good outcomes, although there is no strong evidence of its extensive use probably due to the retrospective nature of the studies, which do not stratify the results depending on the Veau.
In our sample, the use of ADM in high-risk oronasal fistula patients had a good outcome. Only patient 4 developed it in postoperative day 23, which was managed conservatively. A progressive and fast reduction until complete closure at 12-month follow-up occurred, probably because of the integration of the ADM that led to better quality of the surrounding tissues [Figure 5].
SureDerm (HansBiomed, Korea), a human-based ADM, is composed of collagen, elastin, and proteoglycans forming a 3D network. As human-derived material, it is processed with radiation and tested to rule out HIV, Hepatovirus B (HVB), HVC, syphilis, Human T-lymphotropic virus (HTLV), and Cytomegalovirus (CMV). There are no current studies using this ADM in cleft palate. However, we are aware that our results are comparable to other bovine- or porcine-based ADM.
Although highly experienced hospitals have reported an incidence of postoperative fistula of 10%, the rate of our sample was 0%. This might be probably due to the limited cases of this study, so we consider that, in a larger series, a higher incidence will be reported. On the other hand, the lack of strong evidence remains as the pitfall for a formal recommendation. Randomized clinical trials, prospective studies, and large series are required to establish a protocol for the use of ADM in cleft palate.
To sum up, the use of ADM has shown a reduction of postoperative fistula in high-risk postoperative fistula patients: patients with narrow or vertical orientation palatal shelves, Veau II–IV, and clefts >10 mm.
This is one more step toward the gold standard in plastic surgery, a tissue-like tissue reconstruction.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Gilardino MS, Aldekhayel S, Govshievich A. A prospective study investigating fistula rate following primary palatoplasty using acellular dermal matrix. Plast Reconstr Surg Glob Open 2018;6:e1826.
Smith DM, Vecchione L, Jiang S, Ford M, Deleyiannis FW, Haralam MA. The Pittsburgh fistula classification system: A standardized scheme for the description of palatal fistulas. Cleft Palate Craniofac J 2007;44:590-4.
Hudson JW, Pickett DO. A 5-year retrospective review of primary palatoplasty cases utilizing an acellular collagen interpositional graft. J Oral Maxillofac Surg 2015;73:1393.e1-3.
Emodi O, Ginini JG, van Aalst JA, Shilo D, Naddaf R, Aizenbud D, et al.
Cleft palate fistula closure utilizing acellular dermal matrix. Plast Reconstr Surg Glob Open 2018;6:e1682.
Calì Cassi L, Massei A. The use of acellular dermal matrix in the closure of oronasal fistulae after cleft palate repair. Plast Reconstr Surg Glob Open 2015;3:e341.
Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: An evidence-based review. Plast Reconstr Surg 2012;130:177-82.
Aslam M, Ishaq I, Malik S, Fayyaz GQ. Frequency of oronasal fistulae in complete cleft palate repair. J Coll Physicians Surg Pak 2015;25:46-9.
Stein MJ, Zhang Z, Fell M, Mercer N, Malic C. Determining postoperative outcomes after cleft palate repair: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg 2019;72:85-91.
Yuan N, Dorafshar AH, Follmar KE, Pendleton C, Ferguson K, Redett RJ 3rd
. Effects of cleft width and veau type on incidence of palatal fistula and velopharyngeal insufficiency after cleft palate repair. Ann Plast Surg 2016;76:406-10.
Clark JM, Saffold SH, Israel JM. Decellularized dermal grafting in cleft palate repair. Arch Facial Plast Surg 2003;5:40-4.
[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]