Postoperative presence of a fistula represents failure of cleft palate repair. The major symptoms associated with fistulas are nasal regurgitation and speech problems. The incidence of postoperative fistula following primary cleft palate repair ranges from 0% to 58%,1 but at leading centers is expected to be under 10%.2
Fistula formation is associated with reduced vascularity and scar tissue; even areas at a distance from the repair, though not burdened with a scar, may still have restricted motility, making tension-free closure, the hallmark of effective palate repair, challenging at best and impossible in certain cases.3,4 As a result, the prognosis for successful fistula closure declines with each added attempt at the repair site.5–8
To close secondary and tertiary palatal fistulas, the surgeon needs to perform a 3-layered, tension-free closure. Often this is achieved by interposing grafts of bone, cartilage, fascia, and fat.9–12 This additional tissue provides a mechanism for tension-free closure and is a safety net against a possible oral layer breakdown of the closure. However, tissue grafts also result in donor-site morbidity with potential cosmetic problems. Allograft material, such as acellular dermal matrix (ADM), resolves these potential complications. In the present study, we retrospectively review the efficacy of using ADM for cleft palate fistula closure.
MATERIALS AND METHODS
Twenty consecutive patients underwent palate fistula closure utilizing ADM from 2013 to 2016; each patient was assigned a Veau palate designation and a Pittsburgh fistula classification.
All patients were treated under general anesthesia using the following techniques depending on the size (large > 10 mm, medium 5–10 mm, and small < 5 mm) and location of the fistula: two-flap palatoplasty, von Langenbeck, or rotational flaps. ADM was shaped according to the fistula size, then firmly sutured to the nasal layer, followed by closure of the oral layer in a tension-free manner. Postoperatively, patients were seen regularly for at least 6 months and assessed with respect to infection, dehiscence, graft rejection, and fistula recurrence.
Table 1 presents a summary of the results for the 20 patients studied, including 11 females and 9 males. Mean patient age was 13.9 years, ranging from 2 to 43 years. The mean length of follow-up was 9.7 months. The initial Veau classification diagnosis for these patients included 13 with Veau IV clefts (65%), 5 type III (25%), and 2 type II (10%). Pittsburgh fistula designation included 7 type III (junction of hard and soft palate), 6 type IV (within the hard palate), and 7 type V (at the junction of the primary and secondary palates; Fig. 1). Most of the fistulas were larger than 10 mm (65%).
The two-flap palatoplasty was predominantly utilized for fistula repairs (15 of 20). Pittsburgh type IV and V fistulas were repaired exclusively by two-flap palatoplasty technique; Pittsburgh type III were repaired utilizing the von Langenbeck (3), two-flap palatoplasty (2), and rotational (in 2 small fistulas) techniques. Complete fistula closure was obtained in 16 patients (80%; Fig. 2); 2 of whom had temporary dehiscence of the oral mucosal layer that subsequently healed without evidence of fistula. Three patients (15%) had partial closure with reduction of the fistula size and minimization of symptoms; 1 of these 3 patients had significant reduction in fistula size and was no longer symptomatic. One patient (5%) had recurrent fistula without improvement in size or extent of nasal regurgitation. The recurrent fistula locations included 1 at the junction of the primary and secondary palates (type V), 2 in the hard palate (IV), and 1 at the junction of the hard and soft palate (III).
Indications for fistula repair are generally related to the symptomatic presentation including hypernasality and nasal regurgitation of oral contents. Although fistula repair has been demonstrated to improve these symptoms,13 often these fistulas are simply not repaired. The patient and family “make their peace with the fistula” or may opt for a palatal appliance that covers the fistula.14,15 However, an obturator is associated with low patient compliance and often provides an insufficient seal, especially as the patient ages.16 Consequently, surgical treatment continues to be the most advocated and effective method for fistula closure.17
Following the initial report by Clark et al.18 of ADM utilized to close a palatal fistula in a single patient, several studies have been published.19–24 ADM, derived from human skin, is devoid of antigenic factors, but preserves dermal elements. Following implantation, cellular components from the host migrate into the ADM without immune rejection.25
In this study, we used the two-flap palatoplasty technique for type IV and V fistulas. For type III fistulas, we used all 3 techniques, depending on the fistula size. Rotational flap techniques were used in smaller fistulas.
The site most likely for fistula recurrence following fistula repair is generally at the junction of the primary and secondary palate (type V)26; however, in our study, similarly to Landheer et al.27 2 fistulas were present within the hard palate (type IV), 1 at the junction of hard and soft palate (type III), and 1 at the junction of the primary and secondary palate (type V). In this series, we achieved complete fistula closure in 16 of 20 patients. Of the 4 patients with fistula recurrence, 1 repair failed and was repaired using a tongue flap. Overall, we had 3 symptomatic fistulas (15%) and a success rate of 85%, with fistula distributions by Pittsburgh classification similar to those seen in other publications. These results are favorable compared with both non-ADM fistula repair recurrence rates (33–37%),19,28 and the most recent reports of fistula repair with ADM (20–33%).26,29
In addition to the tension-free closure achieved by interposing autografts, the ADM provides a scaffold for tissue ingrowth, revascularization, and mucosal epithelialization without any evidence of donor-site morbidity or immunologic rejection and the expense of additional surgery time.
Utilizing ADM for cleft palate fistula repair as an interposition layer is a safe and simple procedure that reduces fistula recurrence compared with closures without ADM. A larger, prospective, randomized trial is required for determining efficacy in secondary and tertiary fistula repairs.
1. Smarius BJ, Breugem CC. Use of early hard palate closure using a vomer flap in cleft lip and palate patients. J Craniomaxillofac Surg. 2016;44:912–918.
2. Hardwicke JT, Landini G, Richard BM. Fistula incidence after primary cleft palate repair: a systematic review of the literature. Plast Reconstr Surg. 2014;134:618e–627e.
3. Abyholm FE, Borchgrevink HH, Eskeland G. Palatal fistulae following cleft palate surgery. Scand J Plast Reconstr Surg. 1979;13:295–300.
4. Posnick JC. Craniofacial and Maxillofacial Surgery in Children and Young Adults. 2000;Vol. 1.: Philadelphia; WB Saunders Company
5. Cohen SR, Kalinowski J, LaRossa D, et al. Cleft palate fistulas: a multivariate statistical analysis of prevalence, etiology, and surgical management. Plast Reconstr Surg. 1991;87:1041–1047.
6. Freda N, Rauso R, Curinga G, et al. Easy closure of anterior palatal fistula with local flaps. J Craniofac Surg. 2010;21:229–232.
7. Muzaffar AR, Byrd HS, Rohrich RJ, et al. Incidence of cleft palate fistula: an institutional experience with two-stage palatal repair. Plast Reconstr Surg. 2001;108:1515–1518.
8. Vos P, Garrity G, Jones D, et al. Bergey’s Manual of Systematic Bacteriology: Volume 3: The Firmicutes. 2011;Vol. 3.: New York; Springer Science & Business Media
9. Bureau S, Penko M, McFadden L. Speech outcome after closure of oronasal fistulas with bone grafts. J Oral Maxillofac Surg. 2001;59:1408–1413; discussion 1413.
10. Pappachan B, Vasant R. Application of bilateral pedicled buccal fat pad in wide primary cleft palate. Br J Oral Maxillofac Surg. 2008;46:310–312.
11. Soukup JW, Snyder CJ, Gengler WR. Free auricular cartilage autograft for repair of an oronasal fistula in a dog. J Vet Dent. 2009;26:86–95.
12. Tunçbilek G, Konaş E, Kayikçioğlu A, et al. Three-layer oronasal fistula repair with sandwiched mastoid fascia graft. J Craniofac Surg. 2012;23:780–783.
13. Jackson MS, Jackson IT, Christie FB. Improvement in speech following closure of anterior palatal fistulas with bone grafts. Br J Plast Surg. 1976;29:295–296.
14. Amaratunga NA. Occurrence of oronasal fistulas in operated cleft palate patients. J Oral Maxillofac Surg. 1988;46:834–838.
15. Craig RD. The management of complete clefts of the lip and palate. Br J Surg. 1967;54:923–931.
16. Musgrave RH, Bremner JC. Complications of cleft palate surgery. Plast Reconstr Surg Transplant Bull. 1960;26:180–189.
17. Hopkins J, Jackson I, Smith W, et al. Large tongue flaps to close massive palatal defects. Eur J Plast Surg. 1999;22:387–393.
18. Clark JM, Saffold SH, Israel JM. Decellularized dermal grafting in cleft palate repair. Arch Facial Plast Surg. 2003;5:40–44; discussion 45.
19. Cole P, Horn TW, Thaller S. The use of decellularized dermal grafting (AlloDerm) in persistent oro-nasal fistulas after tertiary cleft palate repair. J Craniofac Surg. 2006;17:636–641.
20. Kirschner RE, Cabiling DS, Slemp AE, et al. Repair of oronasal fistulae with acellular dermal matrices. Plast Reconstr Surg. 2006;118:1431–1440.
21. Steele MH, Seagle MB. Palatal fistula repair using acellular dermal matrix: the University of Florida experience. Ann Plast Surg. 2006;56:50–53; discussion 53.
22. El-Kassaby MA, Khalifah MA, Metwally SA, et al. Acellular dermal matrix allograft: an effective adjunct to oronasal fistula repair in patients with cleft palate. Ann Maxillofac Surg. 2014;4:158–161.
23. Losee JE, Smith DM, Afifi AM, et al. A successful algorithm for limiting postoperative fistulae following palatal procedures in the patient with orofacial clefting. Plast Reconstr Surg. 2008;122:544–554.
24. Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: an evidence-based review. Plast Reconstr Surg. 2012;130:177–182.
25. Livesey SA, Herndon DN, Hollyoak MA, et al. Transplanted acellular allograft dermal matrix. Potential as a template for the reconstruction of viable dermis. Transplantation. 1995;60:1–9.
26. Richardson S, Hoyt JS, Khosla RK, et al. Use of regenerative tissue matrix as an oral layer for the closure of recalcitrant anterior palatal fistulae: a pilot study. J Korean Assoc Oral Maxillofac Surg. 2016;42:77–83.
27. Landheer JA, Breugem CC, van der Molen AB. Fistula incidence and predictors of fistula occurrence after cleft palate repair: two-stage closure versus one-stage closure. Cleft Palate Craniofac J. 2010;47:623–630.
28. Assunçao AG. The design of tongue flaps for the closure of palatal fistulas. Plast Reconstr Surg. 1993;91:806–810.
29. Agir H, Eren GG, Yasar EK. Acellular dermal matrix use in cleft palate and palatal fistula repair: a potential benefit? J Craniofac Surg. 2015;26:1517–1522.