- Email: [email protected]
Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis
YIJOM-3393; No of Pages 3
Int. J. Oral Maxillofac. Surg. 2016; xxx: xxx–xxx http://dx.doi.org/10.1016/j.ijom.2016.03.016, available online at http://www.sciencedirect.com
Technical Note Clinical Pathology
Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis
A. Beech, J. Farrier Department of Oral and Maxillofacial Surgery, Gloucestershire Royal Hospital, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, Gloucestershire, UK
A. Beech, J. Farrier: Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis. Int. J. Oral Maxillofac. Surg. 2016; xxx: xxx–xxx. # 2016 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Abstract. The objective was to trial the use of the Integra skin regeneration system intraorally to promote healing of an intraoral defect in osteoradionecrosis (ORN), thereby avoiding the necessity for mucosal flaps, free flaps, or skin grafts. A 54year-old male patient presented with a pathological mandibular fracture at the angle, related to previous radiotherapy for tonsillar carcinoma, after the development of ORN. The fracture site was debrided and fixed with a reconstruction plate and the intraoral defect was dressed with the Integra two-layer system and an overlying pack. Three weeks later, the pack and silicone layer of the regeneration system were removed, showing early granulation over the previously exposed bone. At 8 weeks postoperative, the defect had healed completely with no need for further reconstruction. Using the method described, excellent healing was seen with the Integra skin regeneration system. A new use for the Integra skin regeneration system has been identified in the authors’ unit. This method is minimally invasive and resulted in good healing in the case presented. The need for further reconstruction with associated increased patient morbidity was avoided in this case.
Osteoradionecrosis (ORN) is a condition that can develop following radiotherapy for the treatment of cancer. It is known to affect between 2% and 22% of patients who have received radiation therapy to the head and neck region. Radiation therapy reduces the vascularity of both bone and the surrounding soft tissue, and the resulting sequelae can be difficult to manage. ORN has been 0901-5027/000001+03
defined as a potentially severe, delayed radiation-induced injury, characterized by bone tissue necrosis, failure to heal, and exposed bone for at least 3 months.1 Bone becomes devitalized, necrosed, and exposed, with associated failure to heal in the absence of tumour recurrence, and has previously been classified by Epstein and Marx to guide treatment planning.
Keywords: osteoradionecrosis; wound healing; skin regeneration systems. Accepted for publication 24 March 2016
However, ORN can occur without bone being exposed, which this classification does not address, therefore a new classification of ORN has been proposed by Lyons et al. to include this parameter.2 ORN causes a significant amount of patient morbidity and associated pain, recurrent infection, and disturbance in function and aesthetics.3 It may cause a pathological
# 2016 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Please cite this article in press as: Beech A, Farrier J. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.03.016
YIJOM-3393; No of Pages 3
2
Beech and Farrier
fracture of the bone. The treatment of ORN of the mandible, and any associated fracture, may require reconstruction with a free vascularized bone graft from the fibula, pelvic bone plus the deep circumflex iliac artery (DCIA), or scapula,3,4 and fixation with titanium reconstruction plates. If conservative management is required due to associated comorbidities, long-term antibiotics with or without the use of hyperbaric oxygen has been used with success, and these also have their place as adjunctive therapies.5 The principal problem is usually eradicating the communication between the affected bone and the oral cavity, thereby preventing contamination with oral bacteria. Reconstruction with the use of vascularized bone flaps with a paddle of skin, free tissue flaps, e.g. radial forearm or rectus abdominis,3,4 or, to fill smaller defects, a local mucosal flap such as a
tongue flap 6, has been used with varying degrees of success. However, these additional procedures may enhance patient morbidity by increasing scarring and creating a further wound at the donor site. The use of a skin regeneration system (Integra; Integra Life Sciences Corp, Plainsboro, NJ, USA) has previously been reported to provide good healing for defects of the head and neck.7 More recently, Singh et al. demonstrated its use in the management of ORN communicating with extraoral wounds.8 The authors decided to trial the Integra skin regeneration system intraorally on a small to moderatesized mandibular defect following the debridement of necrotic bone and placement of an extraoral reconstruction plate. The aim was to eradicate the oral communication with the bone and promote full bony healing in a closed environment.
Integra is made of a combined bovine type I collagen and shark chondroitin-6sulphate glycosaminoglycan bound to a silicone pseudoepidermis. The bovine dermal collagen component allows fibroblasts to be incorporated into the Integra matrix, resulting in the formation of a neodermis. It then facilitates graft placement onto the neodermis. A one-stage Integra procedure with subsequent healing by secondary intention has been shown to be successful in other areas of the head and neck.9,10 Thus, it was aimed to trial a one-stage procedure using Integra to gain healing in an intraoral mandibular defect arising in ORN. Case report
A 54-year-old male presented to the department of oral and maxillofacial surgery with pain, difficulty eating, and a foul taste in his mouth that he had experienced with
Fig. 1. (A) Preoperative clinical photograph revealing necrotic, exposed bone and an intraoral defect. (B) Two-layer Integra system in position over the debrided and bleeding bone. (C) Early granulation of the defect at 3 weeks, directly after pack and Integra removal. (D) Full mucosal healing at 8 weeks after pack and Integra removal.
Please cite this article in press as: Beech A, Farrier J. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.03.016
YIJOM-3393; No of Pages 3
Integra skin regeneration system for ORN increasing severity over the previous 3 months. He also had anaesthesia of his right inferior dental nerve. His medical history included a left-sided tonsillar carcinoma treated with surgical excision and radiotherapy 5 years previously. He had not had a dental health assessment before treatment. He was fit and well, taking no regular medication. Clinical examination revealed a 2.4 1.5 cm intraoral defect with exposed and visibly necrotic bone associated with an active draining infection (Fig. 1A). Radiographic and histological examination confirmed ORN surrounding his lower right first and second molar teeth and a pathological fracture of the mandibular angle. The two teeth involved in the area of ORN were extracted and the patient was placed on antibiotics prior to a secondstage procedure. Two weeks later, the patient underwent a general anaesthetic for the debridement of ORN at the mandibular angle and placement of a large titanium reconstruction plate via an approach through the neck to access the fracture site. The remaining intraoral defect could not be closed due to a lack of remaining soft and hard tissue following debridement. An appropriately sized oval of the twolayer Integra skin regeneration system was placed directly onto the bone (Fig. 1B), which had been debrided until bleeding. This was directly covered by a Mepitel bolster and an overlying ribbon gauze pack. The pack was secured in place with 4–0 Vicryl sutures to the mucosa at the edge of the defect. This acted as a bolster over the Integra system preventing communication between the oral cavity and the mandible/neck during healing. To aid healing further, a nasogastric feeding tube was placed intraoperatively. The patient remained completely nil by mouth for 3 days and took only clear oral fluids for a further 2 days. The nasogastric tube was removed at 5 days postoperative. The Mepitel bolster, ribbon gauze pack, and the top silicone layer of the Integra were removed 3 weeks later, showing early granulation of the bone (Fig. 1C). The area then continued to granulate until full mucosal coverage occurred at about 8 weeks. No intraoral communication remained (Fig. 1D) and no further ORN has occurred.
Discussion
This new technique using a skin regeneration system (Integra) was very effective in resolving this case of an intraoral defect of ORN in the mandible. It allowed the localized and minimally invasive treatment of ORN of the mandible. The use of a free flap, local flap, or graft, which may have increased patient morbidity, was also avoided. The authors do accept that there are limitations to this technique. The skin regeneration system requires a blood supply for the development of a neodermis from either bone or neighbouring mucosa in the defect. In cases where no healthy vascularized bone can be found, or where there is a poor quality local blood supply in the mucosa, the technique will not work. In addition, larger defects would be very difficult to manage in this way and are more likely to require free tissue transfer. Having demonstrated the success of this single-stage skin regeneration system, with subsequent granulation and healing by secondary intention in this case, it is proposed that it may also be helpful in similar cases of minor to moderate intraoral defects of other cause, e.g., the oral rehabilitation and release of scarred and tethered mucosa following oral cancer resection and reconstruction. Funding
None. Competing interests
None. Ethical approval
3
2. Lyons A, Osher J, Warner E, Kumar R, Brennan PA. Osteoradionecrosis—a review of current concepts in defining the extent of the disease and a new classification proposal. Br J Oral Maxillofac Surg 2014;52:392–5. 3. Nadella KR, Kodali RM, Guttikonda LK, Jonnalagadda A. Osteoradionecrosis of the jaws: clinico-therapeutic management: a literature review and update. J Maxillofac Oral Surg 2015;14:891–901. http://dx.doi.org/10. 1007/s12663-015-0762-9. 4. Lee M, Chin RY, Eslick GD, Sritharan N, Paramaesvaran S. Outcomes of microvascular free flap reconstruction for mandibular osteoradionecrosis: a systematic review. J Craniomaxillofac Surg 2015;43:2026–33. 5. D’Souza J, Lowe D, Rogers SN. Changing trends and the role of medical management on the outcome of patients treated for osteoradionecrosis of the mandible: experience from a regional head and neck unit. Br J Oral Maxillofac Surg 2014;52:356–62. 6. Ceran C, Demirseren ME, Sarici M, Durgun M, Tekin F. Tongue flap as a reconstructive option in intraoral defects. J Craniofac Surg 2013;24:972–4. 7. Khan MA, Ali SN, Farid M, Pancholi M, Rayatt S, Yap LH. Use of dermal regeneration template (Integra) for reconstruction of full-thickness complex oncologic scalp defects. J Craniofac Surg 2010;21:905–9. 8. Singh M, Godden D, Farrier J, Ilankovan V. The use of Integra and full thickness skin grafts to reconstruct exposed bone in the head and neck. Br J Oral Maxillofac Surg 2016. 9. Burd A, Wong PS. One-stage Integra reconstruction in head and neck defects. J Plast Reconstr Aesthet Surg 2010;63:404–9. 10. De Angelis B, Gentile P, Tati E, Bottini DJ, Bocchini I, Orlandi F, Pepe G, Segni CD, Cervelli G, Cervelli V. One-stage reconstruction of scalp after full-thickness oncologic defects using a dermal regeneration template (Integra). Biomed Res Int 2015;2015. Available online www.hindawi.com/journals/ bmri/2015/698385/.
Not required. Patient consent
Written consent was obtained. References 1. Støre G, Boysen M. Mandibular osteoradionecrosis: clinical behaviour and diagnostic aspects. Clin Otolaryngol Allied Sci 2000;25: 378–84.
Address: Andrea Beech Department of Oral and Maxillofacial Surgery Gloucestershire Royal Hospital Gloucestershire Hospitals NHS Foundation Trust Great Western Road Gloucester Gloucestershire GL1 3NN UK E-mail: [email protected]
Please cite this article in press as: Beech A, Farrier J. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.03.016
Int. J. Oral Maxillofac. Surg. 2016; xxx: xxx–xxx http://dx.doi.org/10.1016/j.ijom.2016.03.016, available online at http://www.sciencedirect.com
Technical Note Clinical Pathology
Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis
A. Beech, J. Farrier Department of Oral and Maxillofacial Surgery, Gloucestershire Royal Hospital, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, Gloucestershire, UK
A. Beech, J. Farrier: Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis. Int. J. Oral Maxillofac. Surg. 2016; xxx: xxx–xxx. # 2016 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Abstract. The objective was to trial the use of the Integra skin regeneration system intraorally to promote healing of an intraoral defect in osteoradionecrosis (ORN), thereby avoiding the necessity for mucosal flaps, free flaps, or skin grafts. A 54year-old male patient presented with a pathological mandibular fracture at the angle, related to previous radiotherapy for tonsillar carcinoma, after the development of ORN. The fracture site was debrided and fixed with a reconstruction plate and the intraoral defect was dressed with the Integra two-layer system and an overlying pack. Three weeks later, the pack and silicone layer of the regeneration system were removed, showing early granulation over the previously exposed bone. At 8 weeks postoperative, the defect had healed completely with no need for further reconstruction. Using the method described, excellent healing was seen with the Integra skin regeneration system. A new use for the Integra skin regeneration system has been identified in the authors’ unit. This method is minimally invasive and resulted in good healing in the case presented. The need for further reconstruction with associated increased patient morbidity was avoided in this case.
Osteoradionecrosis (ORN) is a condition that can develop following radiotherapy for the treatment of cancer. It is known to affect between 2% and 22% of patients who have received radiation therapy to the head and neck region. Radiation therapy reduces the vascularity of both bone and the surrounding soft tissue, and the resulting sequelae can be difficult to manage. ORN has been 0901-5027/000001+03
defined as a potentially severe, delayed radiation-induced injury, characterized by bone tissue necrosis, failure to heal, and exposed bone for at least 3 months.1 Bone becomes devitalized, necrosed, and exposed, with associated failure to heal in the absence of tumour recurrence, and has previously been classified by Epstein and Marx to guide treatment planning.
Keywords: osteoradionecrosis; wound healing; skin regeneration systems. Accepted for publication 24 March 2016
However, ORN can occur without bone being exposed, which this classification does not address, therefore a new classification of ORN has been proposed by Lyons et al. to include this parameter.2 ORN causes a significant amount of patient morbidity and associated pain, recurrent infection, and disturbance in function and aesthetics.3 It may cause a pathological
# 2016 Published by Elsevier Ltd on behalf of International Association of Oral and Maxillofacial Surgeons.
Please cite this article in press as: Beech A, Farrier J. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.03.016
YIJOM-3393; No of Pages 3
2
Beech and Farrier
fracture of the bone. The treatment of ORN of the mandible, and any associated fracture, may require reconstruction with a free vascularized bone graft from the fibula, pelvic bone plus the deep circumflex iliac artery (DCIA), or scapula,3,4 and fixation with titanium reconstruction plates. If conservative management is required due to associated comorbidities, long-term antibiotics with or without the use of hyperbaric oxygen has been used with success, and these also have their place as adjunctive therapies.5 The principal problem is usually eradicating the communication between the affected bone and the oral cavity, thereby preventing contamination with oral bacteria. Reconstruction with the use of vascularized bone flaps with a paddle of skin, free tissue flaps, e.g. radial forearm or rectus abdominis,3,4 or, to fill smaller defects, a local mucosal flap such as a
tongue flap 6, has been used with varying degrees of success. However, these additional procedures may enhance patient morbidity by increasing scarring and creating a further wound at the donor site. The use of a skin regeneration system (Integra; Integra Life Sciences Corp, Plainsboro, NJ, USA) has previously been reported to provide good healing for defects of the head and neck.7 More recently, Singh et al. demonstrated its use in the management of ORN communicating with extraoral wounds.8 The authors decided to trial the Integra skin regeneration system intraorally on a small to moderatesized mandibular defect following the debridement of necrotic bone and placement of an extraoral reconstruction plate. The aim was to eradicate the oral communication with the bone and promote full bony healing in a closed environment.
Integra is made of a combined bovine type I collagen and shark chondroitin-6sulphate glycosaminoglycan bound to a silicone pseudoepidermis. The bovine dermal collagen component allows fibroblasts to be incorporated into the Integra matrix, resulting in the formation of a neodermis. It then facilitates graft placement onto the neodermis. A one-stage Integra procedure with subsequent healing by secondary intention has been shown to be successful in other areas of the head and neck.9,10 Thus, it was aimed to trial a one-stage procedure using Integra to gain healing in an intraoral mandibular defect arising in ORN. Case report
A 54-year-old male presented to the department of oral and maxillofacial surgery with pain, difficulty eating, and a foul taste in his mouth that he had experienced with
Fig. 1. (A) Preoperative clinical photograph revealing necrotic, exposed bone and an intraoral defect. (B) Two-layer Integra system in position over the debrided and bleeding bone. (C) Early granulation of the defect at 3 weeks, directly after pack and Integra removal. (D) Full mucosal healing at 8 weeks after pack and Integra removal.
Please cite this article in press as: Beech A, Farrier J. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.03.016
YIJOM-3393; No of Pages 3
Integra skin regeneration system for ORN increasing severity over the previous 3 months. He also had anaesthesia of his right inferior dental nerve. His medical history included a left-sided tonsillar carcinoma treated with surgical excision and radiotherapy 5 years previously. He had not had a dental health assessment before treatment. He was fit and well, taking no regular medication. Clinical examination revealed a 2.4 1.5 cm intraoral defect with exposed and visibly necrotic bone associated with an active draining infection (Fig. 1A). Radiographic and histological examination confirmed ORN surrounding his lower right first and second molar teeth and a pathological fracture of the mandibular angle. The two teeth involved in the area of ORN were extracted and the patient was placed on antibiotics prior to a secondstage procedure. Two weeks later, the patient underwent a general anaesthetic for the debridement of ORN at the mandibular angle and placement of a large titanium reconstruction plate via an approach through the neck to access the fracture site. The remaining intraoral defect could not be closed due to a lack of remaining soft and hard tissue following debridement. An appropriately sized oval of the twolayer Integra skin regeneration system was placed directly onto the bone (Fig. 1B), which had been debrided until bleeding. This was directly covered by a Mepitel bolster and an overlying ribbon gauze pack. The pack was secured in place with 4–0 Vicryl sutures to the mucosa at the edge of the defect. This acted as a bolster over the Integra system preventing communication between the oral cavity and the mandible/neck during healing. To aid healing further, a nasogastric feeding tube was placed intraoperatively. The patient remained completely nil by mouth for 3 days and took only clear oral fluids for a further 2 days. The nasogastric tube was removed at 5 days postoperative. The Mepitel bolster, ribbon gauze pack, and the top silicone layer of the Integra were removed 3 weeks later, showing early granulation of the bone (Fig. 1C). The area then continued to granulate until full mucosal coverage occurred at about 8 weeks. No intraoral communication remained (Fig. 1D) and no further ORN has occurred.
Discussion
This new technique using a skin regeneration system (Integra) was very effective in resolving this case of an intraoral defect of ORN in the mandible. It allowed the localized and minimally invasive treatment of ORN of the mandible. The use of a free flap, local flap, or graft, which may have increased patient morbidity, was also avoided. The authors do accept that there are limitations to this technique. The skin regeneration system requires a blood supply for the development of a neodermis from either bone or neighbouring mucosa in the defect. In cases where no healthy vascularized bone can be found, or where there is a poor quality local blood supply in the mucosa, the technique will not work. In addition, larger defects would be very difficult to manage in this way and are more likely to require free tissue transfer. Having demonstrated the success of this single-stage skin regeneration system, with subsequent granulation and healing by secondary intention in this case, it is proposed that it may also be helpful in similar cases of minor to moderate intraoral defects of other cause, e.g., the oral rehabilitation and release of scarred and tethered mucosa following oral cancer resection and reconstruction. Funding
None. Competing interests
None. Ethical approval
3
2. Lyons A, Osher J, Warner E, Kumar R, Brennan PA. Osteoradionecrosis—a review of current concepts in defining the extent of the disease and a new classification proposal. Br J Oral Maxillofac Surg 2014;52:392–5. 3. Nadella KR, Kodali RM, Guttikonda LK, Jonnalagadda A. Osteoradionecrosis of the jaws: clinico-therapeutic management: a literature review and update. J Maxillofac Oral Surg 2015;14:891–901. http://dx.doi.org/10. 1007/s12663-015-0762-9. 4. Lee M, Chin RY, Eslick GD, Sritharan N, Paramaesvaran S. Outcomes of microvascular free flap reconstruction for mandibular osteoradionecrosis: a systematic review. J Craniomaxillofac Surg 2015;43:2026–33. 5. D’Souza J, Lowe D, Rogers SN. Changing trends and the role of medical management on the outcome of patients treated for osteoradionecrosis of the mandible: experience from a regional head and neck unit. Br J Oral Maxillofac Surg 2014;52:356–62. 6. Ceran C, Demirseren ME, Sarici M, Durgun M, Tekin F. Tongue flap as a reconstructive option in intraoral defects. J Craniofac Surg 2013;24:972–4. 7. Khan MA, Ali SN, Farid M, Pancholi M, Rayatt S, Yap LH. Use of dermal regeneration template (Integra) for reconstruction of full-thickness complex oncologic scalp defects. J Craniofac Surg 2010;21:905–9. 8. Singh M, Godden D, Farrier J, Ilankovan V. The use of Integra and full thickness skin grafts to reconstruct exposed bone in the head and neck. Br J Oral Maxillofac Surg 2016. 9. Burd A, Wong PS. One-stage Integra reconstruction in head and neck defects. J Plast Reconstr Aesthet Surg 2010;63:404–9. 10. De Angelis B, Gentile P, Tati E, Bottini DJ, Bocchini I, Orlandi F, Pepe G, Segni CD, Cervelli G, Cervelli V. One-stage reconstruction of scalp after full-thickness oncologic defects using a dermal regeneration template (Integra). Biomed Res Int 2015;2015. Available online www.hindawi.com/journals/ bmri/2015/698385/.
Not required. Patient consent
Written consent was obtained. References 1. Støre G, Boysen M. Mandibular osteoradionecrosis: clinical behaviour and diagnostic aspects. Clin Otolaryngol Allied Sci 2000;25: 378–84.
Address: Andrea Beech Department of Oral and Maxillofacial Surgery Gloucestershire Royal Hospital Gloucestershire Hospitals NHS Foundation Trust Great Western Road Gloucester Gloucestershire GL1 3NN UK E-mail: [email protected]
Please cite this article in press as: Beech A, Farrier J. Use of the Integra skin regeneration system in an intraoral mandibular defect in osteoradionecrosis, Int J Oral Maxillofac Surg (2016), http://dx.doi.org/10.1016/j.ijom.2016.03.016