The Experts below are selected from a list of 264 Experts worldwide ranked by ideXlab platform
Keith Harding - One of the best experts on this subject based on the ideXlab platform.
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a prospective multicentre randomised controlled study of human fibroblast derived dermal substitute Dermagraft in patients with venous leg ulcers
International Wound Journal, 2013Co-Authors: Keith Harding, Michael Sumner, Matthew CardinalAbstract:This was an open-label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast-derived dermal substitute (HFDS) plus four-layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty-four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P=0·235). For ulcers≤12months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12weeks (P=0·029). For ulcers≤10cm2, complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P=0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.
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A prospective, multicentre, randomised controlled study of human fibroblast‐derived dermal substitute (Dermagraft) in patients with venous leg ulcers
International Wound Journal, 2013Co-Authors: Keith Harding, Michael Sumner, Matthew CardinalAbstract:This was an open-label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast-derived dermal substitute (HFDS) plus four-layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty-four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P=0·235). For ulcers≤12months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12weeks (P=0·029). For ulcers≤10cm2, complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P=0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.
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the clinical and histological effects of Dermagraft in the healing of chronic venous leg ulcers
Phlebology, 2003Co-Authors: Latha Krishnamoorthy, Keith Harding, David J Griffiths, Keith Moore, David Leaper, K R Poskitt, Gary R Sibbald, Alain Brassard, Kenneth N Dolynchuk, Julian J AdamsAbstract:Objective: Pilot study to assess the safety and effectiveness of Dermagraft® when used in conjunction with multi-layer compression bandage therapy (Profore) compared with multi-layer compression only in the treatment of chronic venous leg ulcers. Design: Open-label, prospective, multicentre, randomized, controlled clinical trial. Methods: Patients aged at least 18 years with leg ulceration of venous aetiology were screened for inclusion in the trial. Patients with arterial disease (ankle brachial pressure index <0.7) and causes of ulceration other than venous disease were excluded. Patients were randomized into four groups. Three active treatment groups received Dermagraft® in combination with compression bandaging, Profore: Group 1, 12 pieces of Dermagraft (one per week for 12 weeks); Group 2, four pieces of Dermagraft (Weeks 0, 1, 4, 8); Group 3, one piece of Dermagraft (Week 0). The control group was treated with compression bandaging alone (Group 4). The study was not powered to detect statistical differences in healing rates. Adverse events were reported according to national guidelines. There was no statistical analysis of adverse event data. Results: In all 53 patients were randomized, of whom 47 completed the study per protocol. At 12 weeks complete healing of the ulcer, analysed by 'intention-to-treat' (ITT) was 15% using Profore alone, 7% using single application Dermagraft and Profore (Group 3), compared with 38% using multiple applications of Dermagraft and Profore (Groups 1 and 2). At study discontinuation, the median percentage reduction in wound area was 81.4% for Group 1, 88.6% for Group 2, 59.4% for Group 3 and 78.1% for Group 4. No major safety issues were identified during the course of the study. Conclusions: The results of the pilot study indicate that four pieces of Dermagraft are the optimal application frequency to take forward to further clinical trials. Further studies are required to confirm these data, and these should be powered to detect whether there are statistical differences in healing rates and safety between different regimens.
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The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers
Phlebology, 2003Co-Authors: Latha Krishnamoorthy, Keith Harding, David J Griffiths, Keith Moore, David Leaper, K R Poskitt, Alain Brassard, Kenneth N Dolynchuk, R. Gary Sibbald, Julian J AdamsAbstract:Objective: Pilot study to assess the safety and effectiveness of Dermagraft® when used in conjunction with multi-layer compression bandage therapy (Profore) compared with multi-layer compression only in the treatment of chronic venous leg ulcers. Design: Open-label, prospective, multicentre, randomized, controlled clinical trial. Methods: Patients aged at least 18 years with leg ulceration of venous aetiology were screened for inclusion in the trial. Patients with arterial disease (ankle brachial pressure index
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enhancement of wound tissue expansion and angiogenesis by matrix embedded fibroblast Dermagraft a role of hepatocyte growth factor scatter factor
International Journal of Molecular Medicine, 1998Co-Authors: Wen Guo Jiang, Keith HardingAbstract:: This study examined the effects of matrix-embedded human fibroblasts, a predominant cell type in the injured tissue, on the tissue expansion and angiogenesis. Using a co-culture technique, it was demonstrated that the presence of matrix-embedded fibroblasts (Dermagraft) significantly enhanced the expansion of human wound tissue in a 3D gel system over a period of 10 days. Using a rat aorta ring assay, fibroblasts also significantly stimulated the growth of new vessels from the ring and also enhanced the motility of human vascular endothelial cells. This effect of fibroblasts was neutralised with anti-HGF/SF antibody. HGF/SF protein was detected in both supernatant and cell lysate of the fibroblasts by bioassay and Western blotting, mRNA for HGF/SF was detected in the fibroblasts by RT-PCR. HGF/SF secreted by the fibroblast was able to stimulate the phosphorylation of cMET, HGF/SF receptor. It is thus concluded that matrix embedded fibroblasts are capable of stimulating wound healing and this effect is attributed to HGF/SF, produced by the cell.
Matthew Cardinal - One of the best experts on this subject based on the ideXlab platform.
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a prospective multicentre randomised controlled study of human fibroblast derived dermal substitute Dermagraft in patients with venous leg ulcers
International Wound Journal, 2013Co-Authors: Keith Harding, Michael Sumner, Matthew CardinalAbstract:This was an open-label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast-derived dermal substitute (HFDS) plus four-layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty-four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P=0·235). For ulcers≤12months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12weeks (P=0·029). For ulcers≤10cm2, complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P=0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.
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A prospective, multicentre, randomised controlled study of human fibroblast‐derived dermal substitute (Dermagraft) in patients with venous leg ulcers
International Wound Journal, 2013Co-Authors: Keith Harding, Michael Sumner, Matthew CardinalAbstract:This was an open-label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast-derived dermal substitute (HFDS) plus four-layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty-four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P=0·235). For ulcers≤12months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12weeks (P=0·029). For ulcers≤10cm2, complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P=0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.
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Human fibroblast-derived dermal substitute: results from a treatment investigational device exemption (TIDE) study in diabetic foot ulcers.
Advances in Skin & Wound Care, 2011Co-Authors: Robert A. Warriner, Matthew CardinalAbstract:OBJECTIVE: To gain experience in the use of Dermagraft (Advanced Biohealing Inc, La Jolla, California), a human fibroblast-derived dermal substitute (HFDS), for the treatment of nonhealing diabetic foot ulcers (DFUs). STUDY DESIGN: An open label, noncontrolled, multicenter clinical trial of HFDS in the treatment of DFU was conducted. Subjects with DFUs underwent sharp debridement of the study ulcer and were prescribed an off-loading device. All of the subjects enrolled received applications of HFDS, beginning at day 0 and applied weekly thereafter, along with saline gauze or polyurethane foam dressings from day 0 to week 20. A maximum of 8 HFDS applications was allowed. MAIN OUTCOME MEASURES: The primary and secondary end points of the study were complete wound closure by weeks 12 and 20, respectively. MAIN RESULTS: A total of 23 centers screened 91 subjects, and 18 centers enrolled an intent-to-treat (ITT) population of 62 subjects. For the ITT population, 27 (44%) subjects healed by week 12, and 32 (52%) healed by week 20. Fifty-one subjects (82%) completed the study to week 12, and 46 subjects (74%) completed the entire 20-week study; wound closure rates in these groups were 59% and 70%, respectively. Median time to healing was 13 weeks. The overall incidence of at least 1 adverse event (44%, 27/62) was typical for this subject population. No adverse events were attributable to HFDS. CONCLUSION: Data from this study support the safety and efficacy of HFDS in the treatment of nonhealing DFUs.
William H. Eaglstein - One of the best experts on this subject based on the ideXlab platform.
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Tissue-engineered skin. Current status in wound healing.
American Journal of Clinical Dermatology, 2012Co-Authors: Ysabel M. Bello, Anna F. Falabella, William H. EaglsteinAbstract:Tissue-engineered skin is a significant advance in the field of wound healing and was developed due to limitations associated with the use of autografts. These limitations include the creation of a donor site which is at risk of developing pain, scarring, infection and/or slow healing. A number of products are commercially available and many others are in development. Cultured epidermal autografts can provide permanent coverage of large area from a skin biopsy. However, 3 weeks are needed for graft cultivation. Cultured epidermal allografts are available immediately and no biopsy is necessary. They can be cryopreserved and banked, but are not currently commercially available. A nonliving allogeneic acellular dermal matrix with intact basement membrane complex (Alloderm®) is immunologically inert. It prepares the wound bed for grafting allowing improved cultured allograft ‘take’ and provides an intact basement membrane. A nonliving extracellular matrix of collagen and chondroitin-6-sulfate with silicone backing (Integra®) serves to generate neodermis. A collagen and glycosaminoglycan dermal matrix inoculated with autologous fibroblasts and keratinocytes has been investigated but is not commercially available. It requires 3 to 4 weeks for cultivation. Dermagraft® consists of living allogeneic dermal fibroblasts grown on degradable scaffold. It has good resistance to tearing. An extracellular matrix generated by allogeneic human dermal fibroblasts (TransCyte™) serves as a matrix for neodermis generation. Apligraf® is a living allogeneic bilayered construct containing keratinocytes, fibroblasts and bovine type I collagen. It can be used on an outpatient basis and avoids the need for a donor site wound. Another living skin equivalent, composite cultured skin (OrCel™), consists of allogeneic fibroblasts and keratinocytes seeded on opposite sides of bilayered matrix of bovine collagen. There are limited clinical data available for this product, but large clinical trials are ongoing. Limited data are also available for 2 types of dressing material derived from pigs: porcine small intestinal submucosa acellular collagen matrix (Oasis™) and an acellular xenogeneic collagen matrix (E-Z-Derm™). Both products have a long shelf life. Other novel skin substitutes are being investigated. The potential risks and benefits of using tissue-engineered skin need to be further evaluated in clinical trials but it is obvious that they offer a new option for the treatment of wounds.
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Tissue-Engineered Skin
American Journal of Clinical Dermatology, 2001Co-Authors: Ysabel M. Bello, Anna F. Falabella, William H. EaglsteinAbstract:Tissue-engineered skin is a significant advance in the field of wound healing and was developed due to limitations associated with the use of autografts. These limitations include the creation of a donor site which is at risk of developing pain, scarring, infection and/or slow healing. A number of products are commercially available and many others are in development. Cultured epidermal autografts can provide permanent coverage of large area from a skin biopsy. However, 3 weeks are needed for graft cultivation. Cultured epidermal allografts are available immediately and no biopsy is necessary. They can be cryopreserved and banked, but are not currently commercially available. A nonliving allogeneic acellular dermal matrix with intact basement membrane complex (Alloderm®) is immunologically inert. It prepares the wound bed for grafting allowing improved cultured allograft ‘take’ and provides an intact basement membrane. A nonliving extracellular matrix of collagen and chondroitin-6-sulfate with silicone backing (Integra®) serves to generate neodermis. A collagen and glycosaminoglycan dermal matrix inoculated with autologous fibroblasts and keratinocytes has been investigated but is not commercially available. It requires 3 to 4 weeks for cultivation. Dermagraft® consists of living allogeneic dermal fibroblasts grown on degradable scaffold. It has good resistance to tearing. An extracellular matrix generated by allogeneic human dermal fibroblasts (TransCyte™) serves as a matrix for neodermis generation. Apligraf® is a living allogeneic bilayered construct containing keratinocytes, fibroblasts and bovine type I collagen. It can be used on an outpatient basis and avoids the need for a donor site wound. Another living skin equivalent, composite cultured skin (OrCel™), consists of allogeneic fibroblasts and keratinocytes seeded on opposite sides of bilayered matrix of bovine collagen. There are limited clinical data available for this product, but large clinical trials are ongoing. Limited data are also available for 2 types of dressing material derived from pigs: porcine small intestinal submucosa acellular collagen matrix (Oasis™) and an acellular xenogeneic collagen matrix (E-Z-Derm™). Both products have a long shelf life. Other novel skin substitutes are being investigated. The potential risks and benefits of using tissue-engineered skin need to be further evaluated in clinical trials but it is obvious that they offer a new option for the treatment of wounds.
S Homervanniasinkam - One of the best experts on this subject based on the ideXlab platform.
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treatment of venous leg ulcers with Dermagraft
European Journal of Vascular and Endovascular Surgery, 2004Co-Authors: A A Omar, A I D Mavor, A M Jones, S HomervanniasinkamAbstract:Abstract Background. A number of different treatment approaches have been recommended for the treatment of venous ulceration, including local ulcer treatment, compression and drug therapy. Recent advances in tissue engineering have resulted in living tissues being developed for cutaneous wound repair and skin replacement. The aim of this pilot study was to compare the rate of healing of venous ulcers in patients treated with Dermagraft (a human fibroblast-derived dermal replacement) and compression therapy or compression therapy alone. Methods. A total of 18 patients with venous ulceration of the leg were recruited into the pilot study. Ten patients were treated with Dermagraft and compression therapy, and eight patients were treated with compression therapy alone. Healing was assessed by ulcer tracing and computerised planimetry. Skin perfusion was measured by laser Doppler. Results. Five (50%) of the patients treated with Dermagraft and one (12.5%) control patient had healed by the end of the 12-week study period (NS). The total ulcer area rate of healing and linear rate of healing was significantly improved in patients treated with Dermagraft ( P =0.001 and P =0.006, respectively, Mann–Whitney U -test). The number of capillaries increased in both the treatment and control group. Peri-ulcer skin perfusion increased by 20% in patients treated with Dermagraft, compared with 4.9% in the control group. Conclusion. The data from this small pilot study suggests that Dermagraft is associated with improved healing of venous ulceration. Following this pilot study, further clinical studies are needed to confirm the validity of these results in ‘hard to heal' venous leg ulcers.
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evaluation of Dermagraft as an alternative to grafting for open fasciotomy wounds
Journal of Wound Care, 2002Co-Authors: A A Omar, A I D Mavor, S HomervanniasinkamAbstract:Wounds produced following open fasciotomy can be healed by grafting but this requires a second operation. Is Dermagraft, a tissue-engineered human fibroblast-derived dermis that can be applied on an outpatient basis, a viable alternative?
R J Snyder - One of the best experts on this subject based on the ideXlab platform.
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118 Dermagraft as an adjunct in the treatment of venous leg ulcers
Wound Repair and Regeneration, 2004Co-Authors: R J SnyderAbstract:Aim: To document successful healing of a recalcitrant venous ulcer with adjunctive use of Dermagraft Materials and Methods: A 74-year-old Hispanic male presented with a chronic venous ulcer at the medial aspect of his right ankle. Biopsy failed to reveal malignancy and confirmed stasis changes. Treatment was ongoing including compression therapy, local debridements, and moist wound healing, off-loading, and nutritional support. The wound remained free of infection. Due to the continued recalcitrant nature of the lesion multiple applications of Dermagraft were utilized to augment healing. Results: The researcher observed dramatic improvement in wound dimensions, wound contracture, and granulation tissue. Conclusions: Dermagraft appears to augment healing in patients with venous ulcers and may be useful as adjunctive therapy. Acknowledgements: Smith & Nephew Wound Management, Largo, Fl.