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Guidelines of care for soft tissue augmentation: Gelatin matrix implant
This report reflects the best data available at the time the report was prepared, but caution should be exercised in interpreting the data; the results of future studies may require alteration of the conclusions or recommendations set forth in this report.
Guidelines of care for soft tissue augmentation: Gelatin matrix implant Guidelines~Outcomes Committee: Lynn A. Drake, MD, Chairman, Scott M. Dinehart, MD, Evan R. Farmer, MD, Robert W. Goltz, MD, Gloria F. Graham, MD, Maria K. Hordinsky, MD, Charles W. Lewis, MD, David M. Pariser, MD, Duane C. Whitaker, MD, Barbara Butler, CPA-SDR Consultant, and Barbara J. Lowery, M P H Task Force: Harold J. Brody, MD, Chairman, Scott M. Dinehart, MD, Melvin L. Elson, MD, C. William Hanke, MD, June K. Robinson, MD, and John W. Skouge, M D
I. Introduction The American Academy of Detmatology's Guidelines/Outcomes Committee is developing guidelines of care for our profession. The development of guidelines will promote the continued delivery of quality care and assist those outside our profession in understanding the complexities and scope of care provided by dermatologists. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration. IL Defimtion Gelatin matrix implant, a porcine derivative collagen powder, is a lyophilized gelatin powder and ~-aminocaproic acid. It is reconstituted with the patient's serum and normal saline solution and stimulates the proliferation of the patient's own collagen through wound healing. This process elevates soft tissue in the treatment of soft-tissue defects resulting from trauma, disease, or aging. III. Rationale A. Scope Trauma or diseases, such as acne, can result in loss of part or all of the dermis and subcutaneous tissue. Similarly, the dermis and underlying
Reprintrequests:AmericanAcademyofDermatology,P.O.Box4014, Schaumburg, IL 60168-4014.(Providedfree of charge) J AMACADDImMATOLI996;34:695-7. Copyright© 1996by the AmericanAcademyof Dermatology,Inc. 0190-9622/96$5.00+0 16/1/70953
tissues alrophy as part of the normal aging process. This atrophy results in wrinkles and furrows in the skin. Gelatin matrix implant, injected intradermally, is replaced by the patient' s own collagen and elevates the soft tissue. The following conditions are amenable to treamaent with gelatin matrix implants: 1. Soft, distensible, depressed scars 2. Some nondistensible scars may be amenable to treatment with gelatin matrix implant with proper undermining. 3. Creases or furrows may respond to gelatin matrix implant. 4. Other The following conditions do not usually respond well to gelatin matrix implants: 1. Very superficial wrinkles 2. Ice pick scars 3. Viral pockmarks 4. Abdominal stretch marks 5. Conditions in which loss of soft tissue is primarily characterized by a loss of subcutaneous tissue 6. Other B. Issue Physician qualifications 1. General a. The physician should have completed residency training or be board certified in an appropriate specialty, such as dermatology. b. The physician should have knowledge of the 1) Skin and subcutaneous tissue
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Drake et al.
2) Components of the gelatin matrix implant to select the proper defects for appropriate undermining and injection. 2. Specific The physician should have appropriate training in gelatin matrix implantation techniques during a. Residency, or b. Postgraduate training that includes hands-on experience. IV. Diagnostic criteria A. Clinical Selection and evaluation of patients are critical in determining the feasibility of the procedure being considered. Patients undergoing gelatin matrix implantation should have an appropriate history and physical examination. 1. History may include a. General medical history as appropriate b. Condition of area being treated 1) Duration 2) Location 3) Precipitating event(s) 4) Previous treatment(s) c. Conditions requiring close evaluation 1) History of bleeding disorders 2) Other d. Conditions that are contraindications to gelatin matrix implantation 1) Reaction to required skin test 2) History of keloids, autoimmune disease, and anaphylactoid reactions 3) Previous allergic reaction or hypersensitivity to any of the components of the gelatin matrix implant (i.e., gelatin, benzyl alcohol, and e-aminocaproic acid) 4) Other e. Other 2. Physical examination may include a. General physical examination as appropriate b. Evaluation ofthe area(s) to be treated to assess the likelihood of improvement with gelatin matrix implants c. Inspection of the skin at and near the area(s) of planned implantation for presence of active dermatologic disease d. Other 3. Other The patient should understand the procedure and its limitations so that expectations are realistic. B. Diagnostic tests
Journal of the American Academy of Dermatology April 1996
Before the initial gelatin matrix implant treatment, only single skin testing is required to identify preexisting allergy to any gelatin matrix implant component. A solution containing 0.05 ml of gelatin and e-aminocaproic acid in saline is injected inlradermally into the volar aspect of the forearm. A positive test is demonstrated by induration and erythema lasting more than 5 hours or appearing more than 24 hours after implantation. If the skin test is negative at 4 weeks, treatment may commence. An equivocal skin test result may necessitate a second test. C. Inappropriate diagnostic tests Not applicable D. Exceptions Not applicable E. Evolving diagnostic tests Not applicable V. Recommendations A. Treatment 1. Medical Not applicable 2. Surgical a. Preoperative 1) Obtain informed consent. 2) Cleanse the area to be treated. 3) May outline area with gentian violet Or similar marking solution. b. Procedure 1) A lyophiliTed preparation of 125 mg of e-aminocaproic acid and 100 mg of gelatin powder is mixed with 0.5 ml of normal saline solution and 0.5 ml of patient plasma. A centlLfuge is necessary to obtain the patient's plasma. 2) A local anesthetic may optionally be administered before the injection of gelatin matrix implant. 3) Gelatin matrix implant is injected into the papillary, mid, or reticular dermis with a 27- to 20-gauge needle. 4) A 20-gauge custom needle is provided in the gelatin matrix implant kit for undermining fibrotic scars. c. Postoperative care Iced dressings may be applied to reduce inflammation. d. Postoperative findings 1) Usual and expected a) Bruising b) Ecchymosis c) Inflammation
Journal of the American Academy of Dermatology Volun~ 34, Number 4
d) Swelling of treatment site (1 to 3 days) 2) Occasional Swelling of the treatment site can last as long as 2 weeks. This occurs especially when gelatin matrix implant is placed in the papillary dermis or when the custom needle undermining of the dermis is performed.
3) Rare a) Allergic treatment site reactions b) Erythema without significant sequelae 3. Evolving Lidocaine 1% and/or additional saline solution may be substituted for plasma, often with equally good results. B. Miscellaneous Not applicable VI. Supporting evidence See Bibliography (Appendix) VII. Disclaimer Adherence to these guidelines will not ensure suecessful treatment in every situation. Further, these guidelines should not be deemed inclusive of all
Drake et ~al. 697 proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
Appendix. Bibliography Millikan L. Long-term safety and efficacy with Fibrel in the treatment of cutaneous scars: results of a multicenter study. J Dermatol Surg Oncol 1989;15:837-42. Millikan L, Banks K, Purkait B, et al. A 5-year safety and efficacy evaluation with Fibrel in the correction of cutaneous scars following one or two treatments. J Dermatol Surg Oncol 1991;17:223-9. Millikan L, Rosen T, Monheit G, et al. Treamaentof depressedcutaneous scars with gelatin matrix implant: a multicenterstudy. J AM ACADDF.RMATOL1987;16:1155-62. Spangler AS. New treatment for pitted scars. Arch Dermatol 1957;76:708-11. Spangler AS. Treatment of depressed scars with fibrin foam: seventeen years of experience. J Dermatol Surg 1975;1:65-9.
Guidelines of care for soft tissue augmentation: Gelatin matrix implant Guidelines~Outcomes Committee: Lynn A. Drake, MD, Chairman, Scott M. Dinehart, MD, Evan R. Farmer, MD, Robert W. Goltz, MD, Gloria F. Graham, MD, Maria K. Hordinsky, MD, Charles W. Lewis, MD, David M. Pariser, MD, Duane C. Whitaker, MD, Barbara Butler, CPA-SDR Consultant, and Barbara J. Lowery, M P H Task Force: Harold J. Brody, MD, Chairman, Scott M. Dinehart, MD, Melvin L. Elson, MD, C. William Hanke, MD, June K. Robinson, MD, and John W. Skouge, M D
I. Introduction The American Academy of Detmatology's Guidelines/Outcomes Committee is developing guidelines of care for our profession. The development of guidelines will promote the continued delivery of quality care and assist those outside our profession in understanding the complexities and scope of care provided by dermatologists. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration. IL Defimtion Gelatin matrix implant, a porcine derivative collagen powder, is a lyophilized gelatin powder and ~-aminocaproic acid. It is reconstituted with the patient's serum and normal saline solution and stimulates the proliferation of the patient's own collagen through wound healing. This process elevates soft tissue in the treatment of soft-tissue defects resulting from trauma, disease, or aging. III. Rationale A. Scope Trauma or diseases, such as acne, can result in loss of part or all of the dermis and subcutaneous tissue. Similarly, the dermis and underlying
Reprintrequests:AmericanAcademyofDermatology,P.O.Box4014, Schaumburg, IL 60168-4014.(Providedfree of charge) J AMACADDImMATOLI996;34:695-7. Copyright© 1996by the AmericanAcademyof Dermatology,Inc. 0190-9622/96$5.00+0 16/1/70953
tissues alrophy as part of the normal aging process. This atrophy results in wrinkles and furrows in the skin. Gelatin matrix implant, injected intradermally, is replaced by the patient' s own collagen and elevates the soft tissue. The following conditions are amenable to treamaent with gelatin matrix implants: 1. Soft, distensible, depressed scars 2. Some nondistensible scars may be amenable to treatment with gelatin matrix implant with proper undermining. 3. Creases or furrows may respond to gelatin matrix implant. 4. Other The following conditions do not usually respond well to gelatin matrix implants: 1. Very superficial wrinkles 2. Ice pick scars 3. Viral pockmarks 4. Abdominal stretch marks 5. Conditions in which loss of soft tissue is primarily characterized by a loss of subcutaneous tissue 6. Other B. Issue Physician qualifications 1. General a. The physician should have completed residency training or be board certified in an appropriate specialty, such as dermatology. b. The physician should have knowledge of the 1) Skin and subcutaneous tissue
695
696
Drake et al.
2) Components of the gelatin matrix implant to select the proper defects for appropriate undermining and injection. 2. Specific The physician should have appropriate training in gelatin matrix implantation techniques during a. Residency, or b. Postgraduate training that includes hands-on experience. IV. Diagnostic criteria A. Clinical Selection and evaluation of patients are critical in determining the feasibility of the procedure being considered. Patients undergoing gelatin matrix implantation should have an appropriate history and physical examination. 1. History may include a. General medical history as appropriate b. Condition of area being treated 1) Duration 2) Location 3) Precipitating event(s) 4) Previous treatment(s) c. Conditions requiring close evaluation 1) History of bleeding disorders 2) Other d. Conditions that are contraindications to gelatin matrix implantation 1) Reaction to required skin test 2) History of keloids, autoimmune disease, and anaphylactoid reactions 3) Previous allergic reaction or hypersensitivity to any of the components of the gelatin matrix implant (i.e., gelatin, benzyl alcohol, and e-aminocaproic acid) 4) Other e. Other 2. Physical examination may include a. General physical examination as appropriate b. Evaluation ofthe area(s) to be treated to assess the likelihood of improvement with gelatin matrix implants c. Inspection of the skin at and near the area(s) of planned implantation for presence of active dermatologic disease d. Other 3. Other The patient should understand the procedure and its limitations so that expectations are realistic. B. Diagnostic tests
Journal of the American Academy of Dermatology April 1996
Before the initial gelatin matrix implant treatment, only single skin testing is required to identify preexisting allergy to any gelatin matrix implant component. A solution containing 0.05 ml of gelatin and e-aminocaproic acid in saline is injected inlradermally into the volar aspect of the forearm. A positive test is demonstrated by induration and erythema lasting more than 5 hours or appearing more than 24 hours after implantation. If the skin test is negative at 4 weeks, treatment may commence. An equivocal skin test result may necessitate a second test. C. Inappropriate diagnostic tests Not applicable D. Exceptions Not applicable E. Evolving diagnostic tests Not applicable V. Recommendations A. Treatment 1. Medical Not applicable 2. Surgical a. Preoperative 1) Obtain informed consent. 2) Cleanse the area to be treated. 3) May outline area with gentian violet Or similar marking solution. b. Procedure 1) A lyophiliTed preparation of 125 mg of e-aminocaproic acid and 100 mg of gelatin powder is mixed with 0.5 ml of normal saline solution and 0.5 ml of patient plasma. A centlLfuge is necessary to obtain the patient's plasma. 2) A local anesthetic may optionally be administered before the injection of gelatin matrix implant. 3) Gelatin matrix implant is injected into the papillary, mid, or reticular dermis with a 27- to 20-gauge needle. 4) A 20-gauge custom needle is provided in the gelatin matrix implant kit for undermining fibrotic scars. c. Postoperative care Iced dressings may be applied to reduce inflammation. d. Postoperative findings 1) Usual and expected a) Bruising b) Ecchymosis c) Inflammation
Journal of the American Academy of Dermatology Volun~ 34, Number 4
d) Swelling of treatment site (1 to 3 days) 2) Occasional Swelling of the treatment site can last as long as 2 weeks. This occurs especially when gelatin matrix implant is placed in the papillary dermis or when the custom needle undermining of the dermis is performed.
3) Rare a) Allergic treatment site reactions b) Erythema without significant sequelae 3. Evolving Lidocaine 1% and/or additional saline solution may be substituted for plasma, often with equally good results. B. Miscellaneous Not applicable VI. Supporting evidence See Bibliography (Appendix) VII. Disclaimer Adherence to these guidelines will not ensure suecessful treatment in every situation. Further, these guidelines should not be deemed inclusive of all
Drake et ~al. 697 proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all the circumstances presented by the individual patient. For the benefit of members of the American Academy of Dermatology who practice outside the jurisdiction of the United States, the listed treatments may include agents that are not currently approved by the U.S. Food and Drug Administration.
Appendix. Bibliography Millikan L. Long-term safety and efficacy with Fibrel in the treatment of cutaneous scars: results of a multicenter study. J Dermatol Surg Oncol 1989;15:837-42. Millikan L, Banks K, Purkait B, et al. A 5-year safety and efficacy evaluation with Fibrel in the correction of cutaneous scars following one or two treatments. J Dermatol Surg Oncol 1991;17:223-9. Millikan L, Rosen T, Monheit G, et al. Treamaentof depressedcutaneous scars with gelatin matrix implant: a multicenterstudy. J AM ACADDF.RMATOL1987;16:1155-62. Spangler AS. New treatment for pitted scars. Arch Dermatol 1957;76:708-11. Spangler AS. Treatment of depressed scars with fibrin foam: seventeen years of experience. J Dermatol Surg 1975;1:65-9.