- Email: [email protected]
Use of a purified collagen membrane to aid closure of palatal fistulae
+
MODEL
Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) xx, 1e5
Use of a purified collagen membrane to aid closure of palatal fistulae* Duncan D. Atherton*, John G. Boorman South Thames Cleft Unit, St Thomas’ Hospital, Westminster Bridge Road, London, SE1 7ET, UK Received 22 January 2015; accepted 18 February 2016
KEYWORDS Cleft; Fistula; Bio Gide; Collagen membrane
Summary Introduction: Fistula formation following closure of palatal clefts remains a difficult clinical complication. A significant recurrence rate has also been reported following attempted closure. We present our results of fistula closure augmented with Bio-Gide , a purified porcine collagen membrane designed to promote guided tissue regeneration. Methods: We reviewed the records of 263 patients operated between 1993 and 2011 for closure of palatal fistula. The patients selected comprised 61 who underwent fistula closure augmented with Bio-Gide and 202 with other techniques in the absence of Bio-Gide. We reviewed the age at surgery, sex, location of fistula, cleft type and outcome. Operation success was defined as an asymptomatic patient along with visible confirmation of closure of the fistula. Results: The overall fistula closure rate was 75% in the Bio-Gide group and 63% in the non-BioGide group (p Z 0.070) and 86% versus 61% in the unilateral cleft palate patients (p Z 0.027). Discussion: Bio-Gide has improved the success rate in fistula closure in this study. Using this technique, fistula closure can be performed as a day case procedure and does not need to transgress any original suture lines; an additional advantage is that this procedure does not require harvesting of any autologous tissue to augment the repair. ª 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Introduction Fistula formation is one of the more common and potentially more troublesome complications of cleft palate * This work was presented at the 2012 Craniofacial Society of Great Britain Meeting in Bristol, 25th April 2012. * Corresponding author. Tel.: þ44 0207 188 1325. E-mail address: [email protected] (D.D. Atherton).
repair. In addition, a significant recurrence rate is observed after attempted closure of these fistulae.1e5 The fistula itself can cause symptoms of nasal regurgitation, malodour and inflammatory irritation as well as a potentially detrimental effect on speech. Direct effects on speech include nasal emission and backing of alveolar consonant targets. Some surgeons further argue that fistula formation can indirectly impair soft palate function, as the secondary contraction of the healing fistula may pull the
http://dx.doi.org/10.1016/j.bjps.2016.02.009 1748-6815/ª 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
2
D.D. Atherton, J.G. Boorman
soft palate anteriorly, thereby leading to velopharyngeal dysfunction. We present our experience of fistula closure over an 18year period, specifically comparing the success rates of those repairs augmented with Bio-Gide, compared to those closed by other methods. Bio-Gide is a resorbable collagen membrane derived from porcine collagen and has been reported extensively in the literature to guide bone and soft tissue regeneration, particularly the use of dental implants.6,7
Patients and methods Over an 18-year period from 1993 to 2011, 263 patients (135 men and 128 women; age: 1e74 years; median: 6 years) underwent closure of palatal fistula. The senior author first introduced the use of Bio-Gide (Geistlich Pharma AG Wolhusen/Switzerland) in 2006; prior to this, fistulae were closed using local flaps often augmented by a variety of substances including conchal cartilage, permacol and dermal grafts. All procedures were carried out under general anaesthesia, and prophylactic Co-amoxiclav was administered. The surgery was usually performed as a day case unless another simultaneous procedure required an overnight stay. The standard surgical technique employed typically involves incision of the margin of the fistula usually with an angled blade, leading to the development of a plane between the nasal and oral layers. Usually, an anterior extension is required along the original suture line to allow access to the developing dissection. Oral flaps are raised to allow closure in the midline and a pocket is created between the nasal and oral layers to allow placement of the Bio-Gide, which is cut to an appropriate shape with an overlap of 5 mm around the fistula (Figures 1 and 2). This is then usually “parachuted” into place with four Vicryl 4.0 (Ethicon Co. Nordersedt/Germany) sutures to hold it in place (Figure 2). The oral layer is then closed over the BioGide without tension. The Bio-Gide should not be left exposed on the oral surface as this has been associated with poorer outcomes at least in the case of oral implants.6 A
Figure 2 The Bio Gide is cut to fit the approximate size of the pocket created between the oral and nasal layers.
watertight closure of the nasal layer is not always possible due to the often narrow access, without performing a more extensive and aggressive dissection. Very large fistulae requiring the use of a tongue flap or a buccal flap were not included in this study. A chi-squared test (c2) was used for statistical comparison of the success rates in fistula closure between the two groups, with a p-value of <0.05 constituting a statistically significant result.
Results The study included 263 fistula operations. The surgeries comprised 61 augmented with Bio-Gide, which were compared with the remaining 202 repairs, including 57 augmented with cartilage, 12 with dermis grafts and six with permacol. The remaining fistulae were closed using local tissue only. Table 1 shows the main characteristics of the two groups. A near-equal gender distribution was observed in the Bio-Gide group, and the non-Bio-Gide group included 104 men and 98 women. The median age for fistula closure was 7.8 years and 5.7 years in the Bio-Gide group and nonBio-Gide group, respectively. All types of fistulae were included: bilateral (BCLP), unilateral (UCLP) and isolated cleft palate (ICP) patients. Table 2 shows the distribution of the fistulae in the two groups, classified according to the Pittsburgh classification
Table 1 Table to show the main characteristics of the two groups of fistulae repairs.
Figure 1 Bio Gide is available off the shelf and requires no particular preparation prior to its use.
Method of Closure
Fistulae augmented with Bio-Gide
Fistulae repaired by other methods
Number in each cohort Male (M)/Female (F) distribution Median age at f istula closure
61
202
M Z 31 F Z 30 7.8 years
M Z 104 F Z 98 5.7 years
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
Use of a purified collagen membrane to aid closure of palatal fistulae Table 2
3
Table to show the distribution of the fistulae in the two groups of repairs according to the Pittsburgh classification.
Pittsburgh Classification
Fistulae augmented with Bio-Gide
Fistulae repaired by other methods
I e Uvular II e Soft palate III e Junction hard/soft palate IV e Hard Palate V e Junction primary/secondary palate VI e Lingual-Alveolar VII e Labial-Alveolar
0% 2% 16% 71% 10% 0% 0%
0% 4% 9% 84% 7% 0% 0%
of palatal fistulae.8 As shown, Type IV, that is, located within the hard palate constituted the vast majority in both groups. A successful operation was defined as an asymptomatic patient with a healed fistula on clinical examination. Figures 3 and 4 show a typical fistula and the outcome of using Bio Gide as an interpositional layer. Antibiotics were administered prophylactically; however, there were no obvious cases of gross clinical infection necessitating a repeat course of antibiotics, although an undetected subclinical infection remains a possible cause for some of the failures. The overall success rate of fistula repair in the patients augmented with Bio-Gide was 75%; the
Figure 3 fistula.
Preoperative appearance of a mid hard palate
Figure 4 Postoperative appearance of the now healed palatal fistula after repair augmented with Bio Gide.
success rate prior to the introduction of Bio-Gide was 63% (Table 3). The chi-squared test was performed to compare the mean successful outcomes in the two groups (c2 Z 3.27, p Z 0.07), thereby indicating a trend toward significance. However, considering the UCLP cases separately, the use of Bio-Gide evidently results in a statistically significant improvement in success rates in fistula closure (c2 Z 4e87, p Z 0.027). There were no observed differences in outcomes between the other methods of augmented closure such as cartilage, permacol or dermis.
Discussion Fistula formation remains one of the more common and potentially more troublesome complications of cleft palate repair, and a significant recurrence rate has been reported after fistula repair.1e5 Recurrence rates in the literature vary widely and few studies deal with a large number of repairs. Nakakita described the use of buccal flaps in 42 cases with a success rate of 52%.1 Cohen et al. reported a success rate in 30 operated cases of 63%.2 Diah et al. describe one of the better rates in similarly positioned fistulae using a two-flap technique of 75% in 64 cases.4 In one of the largest studies identifiable in the literature, Freda et al. report a success rate of 65% in 117 cases.5 Given the potential difficulty in closing these fistulae, various methods firstly of repair and secondly of augmentation have been described. There are a number of methods described using autologous tissue for fistula closure. These include local tissue from the palate, including simply raising the adjacent mucosa9 to raising large mucoperiosteal flaps, which have even been combined with osmotic expanders.10 Local options include buccinator flaps,11 buccal fat,12,13 the facial artery muscolomucosal (FAMM) flap,14 tongue flaps15; septal flaps16 or turbinate flaps.17 Autologous grafts have been described using conchal cartilage18,19 and even free tissue transfers in extreme cases.20e23 Closures have also been augmented with a number of nonautologous materials including alloderm,24e26 amniotic membrane27 and plasma rich in growth factors.28 The availability of several techniques curtails the identification of a single useful method. The utility of these methods cannot be easily assessed due to the limited number of studies. It seems logical that raising larger flaps or even raising of the entire palatal gingivoperiosteum may result in a more watertight closure and yield better success rates, but this
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
4
D.D. Atherton, J.G. Boorman Table 3 Table to show the results of cleft palate fistula closure. Results are shown comparing fistulae closed with and without Bio-Gide, and for each subtype of patient and for all patient groups combined. Cleft type
Biogide used
Success rate No biogide used Success rate Chi squared; fistula with Bio-Gide closure success rates Total Success Failure Total Success Failure without Bio-Gide with vs. without number number Bio-Gide
UCLP BCLP ICP All cleft types together
22 13 26 61
19 9 18 46
3 4 8 15
86% 69% 69% 75%
has to be balanced against the potential for growth disturbance in the younger patient, the increased surgical morbidity, postoperative pain and potential for longer hospital stays. The use of Bio-Gide in cleft surgery has been reported previously. It has been used to augment alveolar bone grafts in children with bilateral cleft lip and palates29; Sader et al.30 have previously reported its use in a small series of 14 patients, reporting a 100% success rate. Bio-Gide is cheap, available off the shelf, does not require a donor site, is easy to handle and bioresorbable, and has good long-term safety data in the field of dental implants.7 Bio-Gide costs approximately £80 from current suppliers which makes it cheaper than other off-the-shelf materials that might otherwise be used such as alloderm. Although the senior author has previously used conchal cartilage,18 it can sometimes be difficult to harvest a large and flat piece, which then has to be scored to create a better contour. By contrast, the Bio-Gide contours well once moistened with saline solution. The definition of surgical success in this study was a patient who was asymptomatic with a closed fistula visible on clinical examination. This is rather strict, as in almost all cases classed as a failure; the residual fistula was considerably smaller on examination. Furthermore, a large number of patients were rendered asymptomatic following surgery, but the presence of fistula was confirmed by examination. However, the success rate in terms of symptom control is >75% compared to that reported earlier. The retrospective design herein limits the study. However, this study is based on a single surgeon’s experience, and the results have been obtained over an 18-year period. The improvements observed over time could be due to a “learning curve.” Notably, the senior author had >10-years experience in cleft surgery before data collection. The working methodology of Bio-Gide is unclear; however, its role as a barrier separating the healing oral and nasal mucosal layers seems probable. If the Bio-Gide is not used, then temporary breakdown at the mucosal suture line may cause the joining of the migrating epithelium from the oral and nasal mucosal layers, thereby re-creating a fistula. Upon using Bio-Gide in situ, the migrating epithelium can still traverse the intact membrane horizontally to the opposing layer, thereby ensuring unison of the nasal and the oral mucosal layers. Fistula closure can be achieved by avoiding overlap of the suture lines and by interposing the membrane between the two mucosal layers. Further, the
61 57 84 202
37 29 61 127
24 28 23 75
61% 51% 73% 63%
P P P P
Z Z Z Z
0.027* 0.230 0.737 0.070
oral layer must be closed without tension and leaving exposed Bio-Gide in the oral layer should be avoided.6 The comparatively greater success in the UCLP group may be attributed to the site of the fistula often being anteriorly placed compared to the isolated palate fistulae. In summary, Bio-Gide is easy to handle and costeffective and hence has been used in the abovementioned techniques. Further, the senior author’s surgical experience validates the use of Bio-Gide in improving the success rate of fistula closure. Postoperative pain is minimal, and generally, patients go home on the day of surgery. Bio-Gide does not transgress the original suture lines, avoids raw areas and also prevents devascularisation of the adjacent palatal tissue. However, the application of this technique is limited to smaller fistulae and is not appropriate for larger ones better suited for tongue, buccinator or FAMM flaps.
Conflict of interests None.
Funding None.
Acknowledgement We would like to thank Dr Siobhan Crichton from the Department of Medical Statistics for her assistance with the statistical analysis in this study.
References 1. Nakakita N, Maeda K, Ando S, Ojimi H, Utsugi R. Use of a buccal musculomucosal flap to close palatal fistulae after cleft palate repair. Br J Plast Surg 1990 Jul;43(4):452e6. 2. Cohen SR, Kalinowski J, LaRossa D, Randall P. Cleft palate fistulas: a multivariate statistical analysis of prevalence, etiology, and surgical management. Plast Reconstr Surg 1991 Jun; 87(6):1041e7. 3. 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 Nov;108(6):1515e8. 4. Diah E, Lo LJ, Yun C, Wang R, Wahyuni LK, Chen YR. Cleft oronasal fistula: a review of treatment results and a surgical
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
Use of a purified collagen membrane to aid closure of palatal fistulae
5.
6.
7.
8.
9. 10.
11.
12.
13.
14.
15. 16. 17.
management algorithm proposal. Chang Gung Med J 2007 NoveDec;30(6):529e37. Freda N, Rauso R, Curinga G, Clemente M, Gherardini G. Easy closure of anterior palatal fistula with local flaps. J Craniofac Surg 2010 Jan;21(1):229e32. Moses O, Pitaru S, Artzi Z, Nemcovsky CE. Healing of dehiscence-type defects in implants placed together with different barrier membranes: a comparative clinical study. Clin Oral Implants Res 2005 Apr;16(2):210e9. Dahlin C, Simion M, Hatano N. Long-term follow-up on soft and hard tissue levels following guided bone regeneration treatment in combination with a xenogeneic filling material: a 5year prospective clinical study. Clin Implant Dent Relat Res 2010 Dec;12(4):263e70. Smith DM, Vecchione L, Jiang S, et al. The Pittsburgh Fistula Classification System: a standardized scheme for the description of palatal fistulas. Cleft Palate Craniofac J 2007 Nov; 44(6):590e4. Rintala A. A double, overlapping hinge flap to close palatal fistula. Scand J Plast Reconstr Surg 1971;5(2):91e5. Jenq TF, Hilliard SM, Kuang AA. Novel use of osmotic tissue expanders to treat difficult anterior palatal fistulas. Cleft Palate Craniofac J 2011 Mar;48(2):217e21. Epub 2010 Apr 23. Bozola AR, Gasques JA, Carriquiry CE, Cardoso de Oliveira M. The buccinator musculomucosal flap: anatomic study and clinical application. Plast Reconstr Surg 1989 Aug;84(2): 250e7. Ashtiani AK, Bohluli B, Kalantar Motamedi MH, Fatemi MJ, Moharamnejad N. Effectiveness of buccal fat in closing residual midpalatal and posterior palatal fistulas in patients previously treated for clefts. J Oral Maxillofac Surg 2011 Nov;69(11): e416e9. Gro ¨be A, Eichhorn W, Hanken H, et al. The use of buccal fat pad (BFP) as a pedicled graft in cleft palate surgery. Int J Oral Maxillofac Surg 2011 Jul;40(7):685e9. Lahiri A, Richard B. Superiorly based facial artery musculomucosal flap for large anterior palatal fistulae in clefts. Cleft Palate Craniofac J 2007 Sep;44(5):523e7. Pigott RW, Rieger FW, Moodie AF. Tongue flap repair of cleft palate fistulae. Br J Plast Surg 1984 Jul;37(3):285e93. Ardehali MM, Farshad A. Repair of palatal defect with nasal septal flap. Int J Oral Maxillofac Surg 2007 Jan;36(1):77e8. Penna V, Bannasch H, Stark GB. The turbinate flap for oronasal fistula closure. Ann Plast Surg 2007 Dec;59(6):679e81.
5
18. Jeffery SL, Boorman JG, Dive DC. Use of cartilage grafts for closure of cleft palate fistulae. Br J Plast Surg 2000 Oct;53(7): 551e4. 19. Ohsumi N, Onizuka T, Ito Y. Use of a free conchal cartilage graft for closure of a palatal fistula: an experimental study and clinical application. Plast Reconstr Surg 1993 Mar;91(3): 433e40. 20. Christiano JG, Dorafshar AH, Rodriguez ED, Redett RJ. Repair of recurrent cleft palate with free vastus lateralis muscle flap. Cleft Palate Craniofac J 2012 Mar;49(2):245e8. 21. Krimmel M, Hoffmann J, Reinert S. Cleft palate fistula closure with a mucosal prelaminated lateral upper arm flap. Plast Reconstr Surg 2005 Dec;116(7):1870e2. 22. Corre ˆa Chem R, Franciosi LF. Dorsalis pedis free flap to close extensive palate fistulae. Microsurgery 1983;4(1):35e9. 23. MacLeod AM, Morrison WA, McCann JJ, Thistlethwaite S, Vanderkolk CA, Ryan AD. The free radial forearm flap with and without bone for closure of large palatal fistulae. Br J Plast Surg 1987 Jul;40(4):391e5. 24. Kirschner RE, Cabiling DS, Slemp AE, Siddiqi F, LaRossa DD, Losee JE. Repair of oronasal fistulae with acellular dermal matrices. Plast Reconstr Surg 2006 Nov;118(6):1431e40. 25. Steele MH, Seagle MB. Palatal fistula repair using acellular dermal matrix: the University of Florida experience. Ann Plast Surg 2006 Jan;56(1):50e3. discussion 53. 26. 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 Jul;17(4): 636e41. 27. Kesting MR, Loeffelbein DJ, Classen M, et al. Repair of oronasal fistulas with human amniotic membrane in minipigs. Br J Oral Maxillofac Surg 2010 Mar;48(2):131e5. 28. Gonza ´lez-Sa ´nchez JG, Jime ´nez-Barraga ´n K. Closure of recurrent cleft palate fistulas with plasma rich in growth factors. Acta Otorrinolaringol Esp 2011 Nov;62(6):448e53. 29. Scott JK, Webb RM, Flood TR. Premaxillary osteotomy and guided tissue regeneration in secondary bone grafting in children with bilateral cleft lip and palate. Cleft Palate Craniofac J 2007 Sep;44(5):469e75. 30. Sader R, Seitz O, Kuttenberger J. Resorbable collagen membrane in surgical repair of fistula following palatoplasty in nonsyndromic cleft palate. Int J Oral Maxillofac Surg 2010 May; 39(5):497e9.
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
MODEL
Journal of Plastic, Reconstructive & Aesthetic Surgery (2016) xx, 1e5
Use of a purified collagen membrane to aid closure of palatal fistulae* Duncan D. Atherton*, John G. Boorman South Thames Cleft Unit, St Thomas’ Hospital, Westminster Bridge Road, London, SE1 7ET, UK Received 22 January 2015; accepted 18 February 2016
KEYWORDS Cleft; Fistula; Bio Gide; Collagen membrane
Summary Introduction: Fistula formation following closure of palatal clefts remains a difficult clinical complication. A significant recurrence rate has also been reported following attempted closure. We present our results of fistula closure augmented with Bio-Gide , a purified porcine collagen membrane designed to promote guided tissue regeneration. Methods: We reviewed the records of 263 patients operated between 1993 and 2011 for closure of palatal fistula. The patients selected comprised 61 who underwent fistula closure augmented with Bio-Gide and 202 with other techniques in the absence of Bio-Gide. We reviewed the age at surgery, sex, location of fistula, cleft type and outcome. Operation success was defined as an asymptomatic patient along with visible confirmation of closure of the fistula. Results: The overall fistula closure rate was 75% in the Bio-Gide group and 63% in the non-BioGide group (p Z 0.070) and 86% versus 61% in the unilateral cleft palate patients (p Z 0.027). Discussion: Bio-Gide has improved the success rate in fistula closure in this study. Using this technique, fistula closure can be performed as a day case procedure and does not need to transgress any original suture lines; an additional advantage is that this procedure does not require harvesting of any autologous tissue to augment the repair. ª 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Introduction Fistula formation is one of the more common and potentially more troublesome complications of cleft palate * This work was presented at the 2012 Craniofacial Society of Great Britain Meeting in Bristol, 25th April 2012. * Corresponding author. Tel.: þ44 0207 188 1325. E-mail address: [email protected] (D.D. Atherton).
repair. In addition, a significant recurrence rate is observed after attempted closure of these fistulae.1e5 The fistula itself can cause symptoms of nasal regurgitation, malodour and inflammatory irritation as well as a potentially detrimental effect on speech. Direct effects on speech include nasal emission and backing of alveolar consonant targets. Some surgeons further argue that fistula formation can indirectly impair soft palate function, as the secondary contraction of the healing fistula may pull the
http://dx.doi.org/10.1016/j.bjps.2016.02.009 1748-6815/ª 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
2
D.D. Atherton, J.G. Boorman
soft palate anteriorly, thereby leading to velopharyngeal dysfunction. We present our experience of fistula closure over an 18year period, specifically comparing the success rates of those repairs augmented with Bio-Gide, compared to those closed by other methods. Bio-Gide is a resorbable collagen membrane derived from porcine collagen and has been reported extensively in the literature to guide bone and soft tissue regeneration, particularly the use of dental implants.6,7
Patients and methods Over an 18-year period from 1993 to 2011, 263 patients (135 men and 128 women; age: 1e74 years; median: 6 years) underwent closure of palatal fistula. The senior author first introduced the use of Bio-Gide (Geistlich Pharma AG Wolhusen/Switzerland) in 2006; prior to this, fistulae were closed using local flaps often augmented by a variety of substances including conchal cartilage, permacol and dermal grafts. All procedures were carried out under general anaesthesia, and prophylactic Co-amoxiclav was administered. The surgery was usually performed as a day case unless another simultaneous procedure required an overnight stay. The standard surgical technique employed typically involves incision of the margin of the fistula usually with an angled blade, leading to the development of a plane between the nasal and oral layers. Usually, an anterior extension is required along the original suture line to allow access to the developing dissection. Oral flaps are raised to allow closure in the midline and a pocket is created between the nasal and oral layers to allow placement of the Bio-Gide, which is cut to an appropriate shape with an overlap of 5 mm around the fistula (Figures 1 and 2). This is then usually “parachuted” into place with four Vicryl 4.0 (Ethicon Co. Nordersedt/Germany) sutures to hold it in place (Figure 2). The oral layer is then closed over the BioGide without tension. The Bio-Gide should not be left exposed on the oral surface as this has been associated with poorer outcomes at least in the case of oral implants.6 A
Figure 2 The Bio Gide is cut to fit the approximate size of the pocket created between the oral and nasal layers.
watertight closure of the nasal layer is not always possible due to the often narrow access, without performing a more extensive and aggressive dissection. Very large fistulae requiring the use of a tongue flap or a buccal flap were not included in this study. A chi-squared test (c2) was used for statistical comparison of the success rates in fistula closure between the two groups, with a p-value of <0.05 constituting a statistically significant result.
Results The study included 263 fistula operations. The surgeries comprised 61 augmented with Bio-Gide, which were compared with the remaining 202 repairs, including 57 augmented with cartilage, 12 with dermis grafts and six with permacol. The remaining fistulae were closed using local tissue only. Table 1 shows the main characteristics of the two groups. A near-equal gender distribution was observed in the Bio-Gide group, and the non-Bio-Gide group included 104 men and 98 women. The median age for fistula closure was 7.8 years and 5.7 years in the Bio-Gide group and nonBio-Gide group, respectively. All types of fistulae were included: bilateral (BCLP), unilateral (UCLP) and isolated cleft palate (ICP) patients. Table 2 shows the distribution of the fistulae in the two groups, classified according to the Pittsburgh classification
Table 1 Table to show the main characteristics of the two groups of fistulae repairs.
Figure 1 Bio Gide is available off the shelf and requires no particular preparation prior to its use.
Method of Closure
Fistulae augmented with Bio-Gide
Fistulae repaired by other methods
Number in each cohort Male (M)/Female (F) distribution Median age at f istula closure
61
202
M Z 31 F Z 30 7.8 years
M Z 104 F Z 98 5.7 years
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
Use of a purified collagen membrane to aid closure of palatal fistulae Table 2
3
Table to show the distribution of the fistulae in the two groups of repairs according to the Pittsburgh classification.
Pittsburgh Classification
Fistulae augmented with Bio-Gide
Fistulae repaired by other methods
I e Uvular II e Soft palate III e Junction hard/soft palate IV e Hard Palate V e Junction primary/secondary palate VI e Lingual-Alveolar VII e Labial-Alveolar
0% 2% 16% 71% 10% 0% 0%
0% 4% 9% 84% 7% 0% 0%
of palatal fistulae.8 As shown, Type IV, that is, located within the hard palate constituted the vast majority in both groups. A successful operation was defined as an asymptomatic patient with a healed fistula on clinical examination. Figures 3 and 4 show a typical fistula and the outcome of using Bio Gide as an interpositional layer. Antibiotics were administered prophylactically; however, there were no obvious cases of gross clinical infection necessitating a repeat course of antibiotics, although an undetected subclinical infection remains a possible cause for some of the failures. The overall success rate of fistula repair in the patients augmented with Bio-Gide was 75%; the
Figure 3 fistula.
Preoperative appearance of a mid hard palate
Figure 4 Postoperative appearance of the now healed palatal fistula after repair augmented with Bio Gide.
success rate prior to the introduction of Bio-Gide was 63% (Table 3). The chi-squared test was performed to compare the mean successful outcomes in the two groups (c2 Z 3.27, p Z 0.07), thereby indicating a trend toward significance. However, considering the UCLP cases separately, the use of Bio-Gide evidently results in a statistically significant improvement in success rates in fistula closure (c2 Z 4e87, p Z 0.027). There were no observed differences in outcomes between the other methods of augmented closure such as cartilage, permacol or dermis.
Discussion Fistula formation remains one of the more common and potentially more troublesome complications of cleft palate repair, and a significant recurrence rate has been reported after fistula repair.1e5 Recurrence rates in the literature vary widely and few studies deal with a large number of repairs. Nakakita described the use of buccal flaps in 42 cases with a success rate of 52%.1 Cohen et al. reported a success rate in 30 operated cases of 63%.2 Diah et al. describe one of the better rates in similarly positioned fistulae using a two-flap technique of 75% in 64 cases.4 In one of the largest studies identifiable in the literature, Freda et al. report a success rate of 65% in 117 cases.5 Given the potential difficulty in closing these fistulae, various methods firstly of repair and secondly of augmentation have been described. There are a number of methods described using autologous tissue for fistula closure. These include local tissue from the palate, including simply raising the adjacent mucosa9 to raising large mucoperiosteal flaps, which have even been combined with osmotic expanders.10 Local options include buccinator flaps,11 buccal fat,12,13 the facial artery muscolomucosal (FAMM) flap,14 tongue flaps15; septal flaps16 or turbinate flaps.17 Autologous grafts have been described using conchal cartilage18,19 and even free tissue transfers in extreme cases.20e23 Closures have also been augmented with a number of nonautologous materials including alloderm,24e26 amniotic membrane27 and plasma rich in growth factors.28 The availability of several techniques curtails the identification of a single useful method. The utility of these methods cannot be easily assessed due to the limited number of studies. It seems logical that raising larger flaps or even raising of the entire palatal gingivoperiosteum may result in a more watertight closure and yield better success rates, but this
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
4
D.D. Atherton, J.G. Boorman Table 3 Table to show the results of cleft palate fistula closure. Results are shown comparing fistulae closed with and without Bio-Gide, and for each subtype of patient and for all patient groups combined. Cleft type
Biogide used
Success rate No biogide used Success rate Chi squared; fistula with Bio-Gide closure success rates Total Success Failure Total Success Failure without Bio-Gide with vs. without number number Bio-Gide
UCLP BCLP ICP All cleft types together
22 13 26 61
19 9 18 46
3 4 8 15
86% 69% 69% 75%
has to be balanced against the potential for growth disturbance in the younger patient, the increased surgical morbidity, postoperative pain and potential for longer hospital stays. The use of Bio-Gide in cleft surgery has been reported previously. It has been used to augment alveolar bone grafts in children with bilateral cleft lip and palates29; Sader et al.30 have previously reported its use in a small series of 14 patients, reporting a 100% success rate. Bio-Gide is cheap, available off the shelf, does not require a donor site, is easy to handle and bioresorbable, and has good long-term safety data in the field of dental implants.7 Bio-Gide costs approximately £80 from current suppliers which makes it cheaper than other off-the-shelf materials that might otherwise be used such as alloderm. Although the senior author has previously used conchal cartilage,18 it can sometimes be difficult to harvest a large and flat piece, which then has to be scored to create a better contour. By contrast, the Bio-Gide contours well once moistened with saline solution. The definition of surgical success in this study was a patient who was asymptomatic with a closed fistula visible on clinical examination. This is rather strict, as in almost all cases classed as a failure; the residual fistula was considerably smaller on examination. Furthermore, a large number of patients were rendered asymptomatic following surgery, but the presence of fistula was confirmed by examination. However, the success rate in terms of symptom control is >75% compared to that reported earlier. The retrospective design herein limits the study. However, this study is based on a single surgeon’s experience, and the results have been obtained over an 18-year period. The improvements observed over time could be due to a “learning curve.” Notably, the senior author had >10-years experience in cleft surgery before data collection. The working methodology of Bio-Gide is unclear; however, its role as a barrier separating the healing oral and nasal mucosal layers seems probable. If the Bio-Gide is not used, then temporary breakdown at the mucosal suture line may cause the joining of the migrating epithelium from the oral and nasal mucosal layers, thereby re-creating a fistula. Upon using Bio-Gide in situ, the migrating epithelium can still traverse the intact membrane horizontally to the opposing layer, thereby ensuring unison of the nasal and the oral mucosal layers. Fistula closure can be achieved by avoiding overlap of the suture lines and by interposing the membrane between the two mucosal layers. Further, the
61 57 84 202
37 29 61 127
24 28 23 75
61% 51% 73% 63%
P P P P
Z Z Z Z
0.027* 0.230 0.737 0.070
oral layer must be closed without tension and leaving exposed Bio-Gide in the oral layer should be avoided.6 The comparatively greater success in the UCLP group may be attributed to the site of the fistula often being anteriorly placed compared to the isolated palate fistulae. In summary, Bio-Gide is easy to handle and costeffective and hence has been used in the abovementioned techniques. Further, the senior author’s surgical experience validates the use of Bio-Gide in improving the success rate of fistula closure. Postoperative pain is minimal, and generally, patients go home on the day of surgery. Bio-Gide does not transgress the original suture lines, avoids raw areas and also prevents devascularisation of the adjacent palatal tissue. However, the application of this technique is limited to smaller fistulae and is not appropriate for larger ones better suited for tongue, buccinator or FAMM flaps.
Conflict of interests None.
Funding None.
Acknowledgement We would like to thank Dr Siobhan Crichton from the Department of Medical Statistics for her assistance with the statistical analysis in this study.
References 1. Nakakita N, Maeda K, Ando S, Ojimi H, Utsugi R. Use of a buccal musculomucosal flap to close palatal fistulae after cleft palate repair. Br J Plast Surg 1990 Jul;43(4):452e6. 2. Cohen SR, Kalinowski J, LaRossa D, Randall P. Cleft palate fistulas: a multivariate statistical analysis of prevalence, etiology, and surgical management. Plast Reconstr Surg 1991 Jun; 87(6):1041e7. 3. 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 Nov;108(6):1515e8. 4. Diah E, Lo LJ, Yun C, Wang R, Wahyuni LK, Chen YR. Cleft oronasal fistula: a review of treatment results and a surgical
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009
+
MODEL
Use of a purified collagen membrane to aid closure of palatal fistulae
5.
6.
7.
8.
9. 10.
11.
12.
13.
14.
15. 16. 17.
management algorithm proposal. Chang Gung Med J 2007 NoveDec;30(6):529e37. Freda N, Rauso R, Curinga G, Clemente M, Gherardini G. Easy closure of anterior palatal fistula with local flaps. J Craniofac Surg 2010 Jan;21(1):229e32. Moses O, Pitaru S, Artzi Z, Nemcovsky CE. Healing of dehiscence-type defects in implants placed together with different barrier membranes: a comparative clinical study. Clin Oral Implants Res 2005 Apr;16(2):210e9. Dahlin C, Simion M, Hatano N. Long-term follow-up on soft and hard tissue levels following guided bone regeneration treatment in combination with a xenogeneic filling material: a 5year prospective clinical study. Clin Implant Dent Relat Res 2010 Dec;12(4):263e70. Smith DM, Vecchione L, Jiang S, et al. The Pittsburgh Fistula Classification System: a standardized scheme for the description of palatal fistulas. Cleft Palate Craniofac J 2007 Nov; 44(6):590e4. Rintala A. A double, overlapping hinge flap to close palatal fistula. Scand J Plast Reconstr Surg 1971;5(2):91e5. Jenq TF, Hilliard SM, Kuang AA. Novel use of osmotic tissue expanders to treat difficult anterior palatal fistulas. Cleft Palate Craniofac J 2011 Mar;48(2):217e21. Epub 2010 Apr 23. Bozola AR, Gasques JA, Carriquiry CE, Cardoso de Oliveira M. The buccinator musculomucosal flap: anatomic study and clinical application. Plast Reconstr Surg 1989 Aug;84(2): 250e7. Ashtiani AK, Bohluli B, Kalantar Motamedi MH, Fatemi MJ, Moharamnejad N. Effectiveness of buccal fat in closing residual midpalatal and posterior palatal fistulas in patients previously treated for clefts. J Oral Maxillofac Surg 2011 Nov;69(11): e416e9. Gro ¨be A, Eichhorn W, Hanken H, et al. The use of buccal fat pad (BFP) as a pedicled graft in cleft palate surgery. Int J Oral Maxillofac Surg 2011 Jul;40(7):685e9. Lahiri A, Richard B. Superiorly based facial artery musculomucosal flap for large anterior palatal fistulae in clefts. Cleft Palate Craniofac J 2007 Sep;44(5):523e7. Pigott RW, Rieger FW, Moodie AF. Tongue flap repair of cleft palate fistulae. Br J Plast Surg 1984 Jul;37(3):285e93. Ardehali MM, Farshad A. Repair of palatal defect with nasal septal flap. Int J Oral Maxillofac Surg 2007 Jan;36(1):77e8. Penna V, Bannasch H, Stark GB. The turbinate flap for oronasal fistula closure. Ann Plast Surg 2007 Dec;59(6):679e81.
5
18. Jeffery SL, Boorman JG, Dive DC. Use of cartilage grafts for closure of cleft palate fistulae. Br J Plast Surg 2000 Oct;53(7): 551e4. 19. Ohsumi N, Onizuka T, Ito Y. Use of a free conchal cartilage graft for closure of a palatal fistula: an experimental study and clinical application. Plast Reconstr Surg 1993 Mar;91(3): 433e40. 20. Christiano JG, Dorafshar AH, Rodriguez ED, Redett RJ. Repair of recurrent cleft palate with free vastus lateralis muscle flap. Cleft Palate Craniofac J 2012 Mar;49(2):245e8. 21. Krimmel M, Hoffmann J, Reinert S. Cleft palate fistula closure with a mucosal prelaminated lateral upper arm flap. Plast Reconstr Surg 2005 Dec;116(7):1870e2. 22. Corre ˆa Chem R, Franciosi LF. Dorsalis pedis free flap to close extensive palate fistulae. Microsurgery 1983;4(1):35e9. 23. MacLeod AM, Morrison WA, McCann JJ, Thistlethwaite S, Vanderkolk CA, Ryan AD. The free radial forearm flap with and without bone for closure of large palatal fistulae. Br J Plast Surg 1987 Jul;40(4):391e5. 24. Kirschner RE, Cabiling DS, Slemp AE, Siddiqi F, LaRossa DD, Losee JE. Repair of oronasal fistulae with acellular dermal matrices. Plast Reconstr Surg 2006 Nov;118(6):1431e40. 25. Steele MH, Seagle MB. Palatal fistula repair using acellular dermal matrix: the University of Florida experience. Ann Plast Surg 2006 Jan;56(1):50e3. discussion 53. 26. 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 Jul;17(4): 636e41. 27. Kesting MR, Loeffelbein DJ, Classen M, et al. Repair of oronasal fistulas with human amniotic membrane in minipigs. Br J Oral Maxillofac Surg 2010 Mar;48(2):131e5. 28. Gonza ´lez-Sa ´nchez JG, Jime ´nez-Barraga ´n K. Closure of recurrent cleft palate fistulas with plasma rich in growth factors. Acta Otorrinolaringol Esp 2011 Nov;62(6):448e53. 29. Scott JK, Webb RM, Flood TR. Premaxillary osteotomy and guided tissue regeneration in secondary bone grafting in children with bilateral cleft lip and palate. Cleft Palate Craniofac J 2007 Sep;44(5):469e75. 30. Sader R, Seitz O, Kuttenberger J. Resorbable collagen membrane in surgical repair of fistula following palatoplasty in nonsyndromic cleft palate. Int J Oral Maxillofac Surg 2010 May; 39(5):497e9.
Please cite this article in press as: Atherton DD, Boorman JG, Use of a purified collagen membrane to aid closure of palatal fistulae, Journal of Plastic, Reconstructive & Aesthetic Surgery (2016), http://dx.doi.org/10.1016/j.bjps.2016.02.009