RARE DISEASE
Partial deep dermal and full thickness burns
Partial deep dermal and full thickness burns
Partial deep dermal and full thickness burns
Drug discovery
19
drugs
With orphan designations
Overview
Partial deep dermal (deep second-degree) and full-thickness burns involve significant destruction of skin layers, extending into the reticular dermis or deeper tissues (subcutaneous fat, muscle, or bone) [1][2][6]. Partial deep dermal burns appear mottled pink/white with minimal blanching and reduced sensation, while full-thickness burns are leathery, insensate, and often charred [1][6][15]. These burns lack sufficient regenerative capacity for spontaneous healing, typically requiring surgical intervention [3][8][12].
Therapies
Deep dermal: Initial conservative management with silver-based dressings (e.g., Acticoat) or enzymatic debridement (NexoBrid®) [3][16], transitioning to tangential excision/grafting if unhealed by 3 weeks [8][12].
Full-thickness: Early excision (within 3–5 days) and autografting; temporizing measures include allografts or synthetic substitutes (Integra®) [12][16].
Categories: rare skin diseases
Research Papers
967 drug discovery papers about Partial deep dermal and full thickness burns, with 1 first-in-class and 14 next-in-class emerging drug candidates forecasted to outperform the average preclinical success rate. Recent publications:
967 drug discovery papers about Partial deep dermal and full thickness burns, with 1 first-in-class and 14 next-in-class emerging drug candidates forecasted to outperform the average preclinical success rate. Recent publications:
2026-07-29 | Bromelain-based enzymatic debridement versus standard of care in deep partial- and full-thickness burns: A systematic review and meta-analysis of randomized controlled trials.
Management of debridement-eligible thermal burns requires accurate removal of devitalized tissue. Tangential excision remains limited by imprecise depth assessment beneath opaque eschar, risking unintended dermal sacrifice. Bromelain-based enzymatic debridement (BBD) has emerged as an alternative; however, its impact on patient-level surgical outcomes has not been rigorously quantified in randomized trials. A systematic review and meta-analysis of randomized trials compared BBD with standard of care (SOC) in acute deep thermal burns. The primary outcome was the proportion requiring surgical excision. Random-effects models pooled effects. A prespecified sensitivity analysis evaluated a wound-level trial. Risk of bias was assessed using the Cochrane RoB 2 tool. Five randomized trials met criteria. Four reporting per-patient outcomes contributed to the primary meta-analysis (n = 336). BBD reduced surgical excision versus SOC (RR, 0.11; 95% CI, 0.06-0.23; I² = 0%), corresponding to an absolute risk reduction of 65% and a number needed to treat of 1.5. BBD was also associated with reduced autograft use, shorter time to debridement, and comparable or improved blinded scar assessments at 12 months. Open-label design was the principal source of potential bias. Sensitivity analysis including the wound-level trial preserved effect direction with increased heterogeneity. Randomized evidence demonstrates that, in early-treated debridement-eligible burns with limited total body surface area burned (TBSA), BBD reduces operative and graft burden without compromising wound closure or long-term remodeling. Future trials incorporating blinded operative endpoint adjudication, objective assessment of dermal preservation and broader clinical outcomes will further clarify treatment effect and optimize patient selection.
2026-06-22 | The Use of Kerecis Omega3 Wound Fish Skin Graft for the Treatment of Deep Burn Wounds.
Addressing deep partial-thickness burns (DPTBs) and full-thickness burns (FTBs) remains a significantly challenging task in modern burn surgery. Among a broad lineup of wound products, biological adjuncts like fish skin-derived scaffolds offer unique regenerative properties, presenting new possibilities in complex wound management. We herein report our institutional clinical experience with the fish skin-based scaffold Kerecis Omega3 Wound. This retrospective, single-center case series evaluated all patients with DPTBs and FTBs treated with Kerecis Omega3 Wound between 2020 and 2024 at the burn center of the University Hospital Zurich. The specific indications for intervention, depth of burn injury, anatomical regions of application, subsequent need for further surgery, and short- and long-term complications were systematically assessed. Twenty-seven patients were reviewed, exhibiting a mean affected total body surface area of 35.73% and an average abbreviated burn severity index score of 7.74. Fish skin was used in an acute setting in 21 cases; for the remaining cases, it was used for chronic wound-healing disturbances following burn injury. The most frequently treated anatomical region was the upper extremity. Almost 50% of the DPTB wounds healed spontaneously following treatment with Kerecis Omega3 Wound. Conversely, all FTBs required further skin grafting or other reconstructive measures. Postsurgical infections occurred in 4 patients, necessitating the removal of the product. Contractures were observed in 3 patients with FTBs during clinical follow-up. Kerecis Omega3 Wound represents a valuable adjunct for wound conditioning in patients with DPTBs, either as a preparation before skin grafting or to stimulate spontaneous wound regeneration. Regarding FTBs, its efficacy in restoring the dermal layer requires further research and clinical validation.
2026-03-27 | Histopathological Changes Following Bromelain-Based Enzymatic Debridement (NexoBrid®): A Comprehensive Systematic Review of Preclinical and Clinical Evidence.
Background: NexoBrid® (NXB; MediWound Ltd., Yavne, Israel) (anacaulase-bcdb) is a bromelain-based enzymatic debriding agent approved for eschar removal in burn care. Despite widespread clinical use, histological evidence of tissue-level changes after enzymatic debridement remains limited. This systematic review aimed to evaluate preclinical and clinical studies describing histological findings following bromelain-based enzymatic debridement of thermal burns. Methods: Following PRISMA 2020 guidelines, we performed parallel systematic searches of preclinical (animal) and clinical (human) studies across PubMed, Embase, CENTRAL, Web of Science, and Scopus. Included studies reported thermal burns treated with bromelain-based enzymatic debridement and tissue biopsies with histological analysis. Quality was assessed using the SYRCLE Risk of Bias Tool (preclinical) and JBI Critical Appraisal Checklists (clinical). Results: Six preclinical studies (five porcine, one rat) met inclusion criteria. Findings included: selective eschar removal with dermal preservation; protection of the zone of stasis (67% partial- vs. 100% full-thickness necrosis; p = 0.05); viable dermal thickness of 1.1 ± 0.7 mm; and accelerated re-epithelialization (7.4 ± 0.8 vs. 9.1 ± 2.1 days; p < 0.05). Only two clinical studies (n = 9 patients) met the inclusion criteria: one case series (n = 8) and one case report. Clinical findings showed upper dermal homogenisation with preserved deep dermis, vascular congestion correlating with pinpoint bleeding, and pseudoeschar formation via transepidermal elimination. Conclusions: Preclinical evidence supports selective enzymatic debridement with dermal preservation. However, clinical histological data are limited to nine patients after over 13 years of use. This highlights a critical translational gap and underscores the need for prospective clinical histological studies.
2026-03-10 | Evaluation of Burn Depth using Indocyanine Green: Discrepancies Between Macroscopic Visualization and the Microenvironment.
Burn wound management is guided by the depth of dermal tissue damage. Standard practice for this depth assessment is daily visual evaluation of the wound by an experienced burn surgeon, which is inherently subjective and at times inaccurate. Perioperative fluorescence imaging with indocyanine green (ICG) has emerged as a potential tool to objectively evaluate burn depth. The current study aims to explore the relationship between ICG angiography (ICGA), Second-window ICG (SWIG), and burn depth, with the goal of understanding how this technology could guide the prognosis and treatment of human burn wounds. Patients (n = 14) with indeterminate depth or deep partial thickness burns received an infusion of ICG on post-burn day 2-3 or the day before surgery. Imaging was performed immediately after injection for angiography as well as the following day for SWIG. A full-thickness tissue biopsy was obtained for histologic evaluation. In vitro primary human fibroblasts and keratinocytes were cultured, subjected to heat injury (65 deg C for 2.5 or 5 minutes), and incubated with ICG. Flow cytometry was used to classify the cells as live, apoptotic, or necrotic based and to quantify ICG uptake. ICGA perfusion parameters are increased in burn wounds that did not require grafting and ICGA egress slope correlates to SWIG fluorescence intensity. Furthermore, SWIG microscopic fluorescence intensity correlates to histologic burn depth and colocalizes in necrotic region of burn injury, however there is high interpatient variability between SWIG fluorescence intensity and histologic burn depth, predicted healing potential, and graft status. Flow cytometric analysis of in vitro skin cells shows that preferential ICG binding to necrotic cells contributes to SWIG signal in a burn, with binding influenced by cell type and injury severity. Overall, this study suggests that fluorescence imaging has the potential to aid in the assessment of healing potential, although current challenges related to imaging variability, interpretation, and clinical integration must be addressed to optimize its utility in burn management.Clinical trials number: NCT05593523.
2026-03-01 | 1013. Case Study. Fish Skin Grafts for Partial-thickness Electrical Burns: A Mini Case Series of Successful Outcomes
Abstract Patient Presentation (age range, injury details, relevant history) A 27-year-old and 36-year-old healthy Hispanic male with Fitzpatrick type IV skin sustained 1% electrical burns to their left (non-dominant) hands during a construction accident. The 27-year-old had superficial and deep second-degree burns to dorsal digits 3-5 (including PIP and DIP joints), with near circumferential wrist involvement. The 36-year-old had superficial second-degree burns to all dorsal digits (including MCP, PIP, and DIP joints) and volar wrist involvement. Clinical Challenges Deep partial thickness burns spanning multiple joints. The goal was to reduce scarring and optimize hand function, focusing on a quick return to work, effective pain management, and brief hospitalization. Management Approach Both patients underwent 5 days of local wound care followed by tangential excision and piscine xenograft coverage. Wound care included twice daily cleansing, Silvadene application, gauze wrap, elastic compression and elevation. Occupational therapy was consulted. Tangential excision was performed with a Goulian blade, followed by the application of piscine xenografts fixed with staples. Sterile dressings included antibiotic ointment, gauze wrap, and an elastic compression bandage. Both patients were discharged with one-week follow-up for dressing changes. Outcomes A mini case series with terrific cosmetic and functional outcomes while providing prompt coverage of a raw wound, thus minimizing pain. Piscine xenograft was pursued in lieu of autograft due to the superficial partial thickness depth. The piscine dermal matrix offered the additional benefits of modulating inflammation, promoting neovascularization and reinforcing the dermal construct with natural collagen, elastin, glycosaminoglycans and extracellular membrane components resulting in a more pliable neodermis. At 1 week post-op, full graft incorporation was noted in deeper areas, while more superficial injuries exhibited partial graft loss as dry, scaly tissue. Neither patient required narcotics postoperatively. Both had some restricted grip formation, more pronounced in the younger male. They were provided wound care, hand exercises, and outpatient occupational therapy prescriptions. At 2 weeks post-op, both patients had full epithelialization, no hypertrophy, and improved range of motion. Wound care transitioned to moisturizing, and they were provided compression gloves and sun exposure precautions. They returned to work at this time without functional deficits. At 7 months post-op, both patients had excellent cosmetic outcomes and regained native functionality, with no hypertrophy or contracture. The patients' lack of co-morbidities and good nutritional status likely aided healing. Lessons Learned In appropriate cases, piscine xenografts can achieve timely wound healing with optimal tissue pliability and cosmesis without the need for autograft, thus reducing procedural time, minimizing pain, and avoiding donor site morbidity. Applicability to Practice:
2026-07-29 | Bromelain-based enzymatic debridement versus standard of care in deep partial- and full-thickness burns: A systematic review and meta-analysis of randomized controlled trials.
Management of debridement-eligible thermal burns requires accurate removal of devitalized tissue. Tangential excision remains limited by imprecise depth assessment beneath opaque eschar, risking unintended dermal sacrifice. Bromelain-based enzymatic debridement (BBD) has emerged as an alternative; however, its impact on patient-level surgical outcomes has not been rigorously quantified in randomized trials. A systematic review and meta-analysis of randomized trials compared BBD with standard of care (SOC) in acute deep thermal burns. The primary outcome was the proportion requiring surgical excision. Random-effects models pooled effects. A prespecified sensitivity analysis evaluated a wound-level trial. Risk of bias was assessed using the Cochrane RoB 2 tool. Five randomized trials met criteria. Four reporting per-patient outcomes contributed to the primary meta-analysis (n = 336). BBD reduced surgical excision versus SOC (RR, 0.11; 95% CI, 0.06-0.23; I² = 0%), corresponding to an absolute risk reduction of 65% and a number needed to treat of 1.5. BBD was also associated with reduced autograft use, shorter time to debridement, and comparable or improved blinded scar assessments at 12 months. Open-label design was the principal source of potential bias. Sensitivity analysis including the wound-level trial preserved effect direction with increased heterogeneity. Randomized evidence demonstrates that, in early-treated debridement-eligible burns with limited total body surface area burned (TBSA), BBD reduces operative and graft burden without compromising wound closure or long-term remodeling. Future trials incorporating blinded operative endpoint adjudication, objective assessment of dermal preservation and broader clinical outcomes will further clarify treatment effect and optimize patient selection.
2026-06-22 | The Use of Kerecis Omega3 Wound Fish Skin Graft for the Treatment of Deep Burn Wounds.
Addressing deep partial-thickness burns (DPTBs) and full-thickness burns (FTBs) remains a significantly challenging task in modern burn surgery. Among a broad lineup of wound products, biological adjuncts like fish skin-derived scaffolds offer unique regenerative properties, presenting new possibilities in complex wound management. We herein report our institutional clinical experience with the fish skin-based scaffold Kerecis Omega3 Wound. This retrospective, single-center case series evaluated all patients with DPTBs and FTBs treated with Kerecis Omega3 Wound between 2020 and 2024 at the burn center of the University Hospital Zurich. The specific indications for intervention, depth of burn injury, anatomical regions of application, subsequent need for further surgery, and short- and long-term complications were systematically assessed. Twenty-seven patients were reviewed, exhibiting a mean affected total body surface area of 35.73% and an average abbreviated burn severity index score of 7.74. Fish skin was used in an acute setting in 21 cases; for the remaining cases, it was used for chronic wound-healing disturbances following burn injury. The most frequently treated anatomical region was the upper extremity. Almost 50% of the DPTB wounds healed spontaneously following treatment with Kerecis Omega3 Wound. Conversely, all FTBs required further skin grafting or other reconstructive measures. Postsurgical infections occurred in 4 patients, necessitating the removal of the product. Contractures were observed in 3 patients with FTBs during clinical follow-up. Kerecis Omega3 Wound represents a valuable adjunct for wound conditioning in patients with DPTBs, either as a preparation before skin grafting or to stimulate spontaneous wound regeneration. Regarding FTBs, its efficacy in restoring the dermal layer requires further research and clinical validation.
2026-03-27 | Histopathological Changes Following Bromelain-Based Enzymatic Debridement (NexoBrid®): A Comprehensive Systematic Review of Preclinical and Clinical Evidence.
Background: NexoBrid® (NXB; MediWound Ltd., Yavne, Israel) (anacaulase-bcdb) is a bromelain-based enzymatic debriding agent approved for eschar removal in burn care. Despite widespread clinical use, histological evidence of tissue-level changes after enzymatic debridement remains limited. This systematic review aimed to evaluate preclinical and clinical studies describing histological findings following bromelain-based enzymatic debridement of thermal burns. Methods: Following PRISMA 2020 guidelines, we performed parallel systematic searches of preclinical (animal) and clinical (human) studies across PubMed, Embase, CENTRAL, Web of Science, and Scopus. Included studies reported thermal burns treated with bromelain-based enzymatic debridement and tissue biopsies with histological analysis. Quality was assessed using the SYRCLE Risk of Bias Tool (preclinical) and JBI Critical Appraisal Checklists (clinical). Results: Six preclinical studies (five porcine, one rat) met inclusion criteria. Findings included: selective eschar removal with dermal preservation; protection of the zone of stasis (67% partial- vs. 100% full-thickness necrosis; p = 0.05); viable dermal thickness of 1.1 ± 0.7 mm; and accelerated re-epithelialization (7.4 ± 0.8 vs. 9.1 ± 2.1 days; p < 0.05). Only two clinical studies (n = 9 patients) met the inclusion criteria: one case series (n = 8) and one case report. Clinical findings showed upper dermal homogenisation with preserved deep dermis, vascular congestion correlating with pinpoint bleeding, and pseudoeschar formation via transepidermal elimination. Conclusions: Preclinical evidence supports selective enzymatic debridement with dermal preservation. However, clinical histological data are limited to nine patients after over 13 years of use. This highlights a critical translational gap and underscores the need for prospective clinical histological studies.
2026-03-10 | Evaluation of Burn Depth using Indocyanine Green: Discrepancies Between Macroscopic Visualization and the Microenvironment.
Burn wound management is guided by the depth of dermal tissue damage. Standard practice for this depth assessment is daily visual evaluation of the wound by an experienced burn surgeon, which is inherently subjective and at times inaccurate. Perioperative fluorescence imaging with indocyanine green (ICG) has emerged as a potential tool to objectively evaluate burn depth. The current study aims to explore the relationship between ICG angiography (ICGA), Second-window ICG (SWIG), and burn depth, with the goal of understanding how this technology could guide the prognosis and treatment of human burn wounds. Patients (n = 14) with indeterminate depth or deep partial thickness burns received an infusion of ICG on post-burn day 2-3 or the day before surgery. Imaging was performed immediately after injection for angiography as well as the following day for SWIG. A full-thickness tissue biopsy was obtained for histologic evaluation. In vitro primary human fibroblasts and keratinocytes were cultured, subjected to heat injury (65 deg C for 2.5 or 5 minutes), and incubated with ICG. Flow cytometry was used to classify the cells as live, apoptotic, or necrotic based and to quantify ICG uptake. ICGA perfusion parameters are increased in burn wounds that did not require grafting and ICGA egress slope correlates to SWIG fluorescence intensity. Furthermore, SWIG microscopic fluorescence intensity correlates to histologic burn depth and colocalizes in necrotic region of burn injury, however there is high interpatient variability between SWIG fluorescence intensity and histologic burn depth, predicted healing potential, and graft status. Flow cytometric analysis of in vitro skin cells shows that preferential ICG binding to necrotic cells contributes to SWIG signal in a burn, with binding influenced by cell type and injury severity. Overall, this study suggests that fluorescence imaging has the potential to aid in the assessment of healing potential, although current challenges related to imaging variability, interpretation, and clinical integration must be addressed to optimize its utility in burn management.Clinical trials number: NCT05593523.
2026-03-01 | 1013. Case Study. Fish Skin Grafts for Partial-thickness Electrical Burns: A Mini Case Series of Successful Outcomes
Abstract Patient Presentation (age range, injury details, relevant history) A 27-year-old and 36-year-old healthy Hispanic male with Fitzpatrick type IV skin sustained 1% electrical burns to their left (non-dominant) hands during a construction accident. The 27-year-old had superficial and deep second-degree burns to dorsal digits 3-5 (including PIP and DIP joints), with near circumferential wrist involvement. The 36-year-old had superficial second-degree burns to all dorsal digits (including MCP, PIP, and DIP joints) and volar wrist involvement. Clinical Challenges Deep partial thickness burns spanning multiple joints. The goal was to reduce scarring and optimize hand function, focusing on a quick return to work, effective pain management, and brief hospitalization. Management Approach Both patients underwent 5 days of local wound care followed by tangential excision and piscine xenograft coverage. Wound care included twice daily cleansing, Silvadene application, gauze wrap, elastic compression and elevation. Occupational therapy was consulted. Tangential excision was performed with a Goulian blade, followed by the application of piscine xenografts fixed with staples. Sterile dressings included antibiotic ointment, gauze wrap, and an elastic compression bandage. Both patients were discharged with one-week follow-up for dressing changes. Outcomes A mini case series with terrific cosmetic and functional outcomes while providing prompt coverage of a raw wound, thus minimizing pain. Piscine xenograft was pursued in lieu of autograft due to the superficial partial thickness depth. The piscine dermal matrix offered the additional benefits of modulating inflammation, promoting neovascularization and reinforcing the dermal construct with natural collagen, elastin, glycosaminoglycans and extracellular membrane components resulting in a more pliable neodermis. At 1 week post-op, full graft incorporation was noted in deeper areas, while more superficial injuries exhibited partial graft loss as dry, scaly tissue. Neither patient required narcotics postoperatively. Both had some restricted grip formation, more pronounced in the younger male. They were provided wound care, hand exercises, and outpatient occupational therapy prescriptions. At 2 weeks post-op, both patients had full epithelialization, no hypertrophy, and improved range of motion. Wound care transitioned to moisturizing, and they were provided compression gloves and sun exposure precautions. They returned to work at this time without functional deficits. At 7 months post-op, both patients had excellent cosmetic outcomes and regained native functionality, with no hypertrophy or contracture. The patients' lack of co-morbidities and good nutritional status likely aided healing. Lessons Learned In appropriate cases, piscine xenografts can achieve timely wound healing with optimal tissue pliability and cosmesis without the need for autograft, thus reducing procedural time, minimizing pain, and avoiding donor site morbidity. Applicability to Practice:
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Drug Discovery Landscape
19 orphan drug designations for Partial deep dermal and full thickness burns, including 3 approved therapies.
19 orphan drug designations for Partial deep dermal and full thickness burns, including 3 approved therapies.
Drug | Therapy type | Regulator | Orphan designation | Approval | Sponsor |
|---|---|---|---|---|---|
Human allogeneic keratinocytes | cell therapies | EMA | 2022-06-21 | — | Evomedis GmbH |
Human keratinocytes | cell therapies | EMA | 2021-08-20 | — | Dizg Deutsches Institut Für Zell- Und Gewebeersatz gGmbH |
Genetically engineered (alpha-1,3-galactosyltransferase knock-out}, live cell porcine (Sus scrofa) xenotransplantation skin graft | cell therapies | FDA | 2021-06-14 | — | XenoTherapeutics, Inc. |
bilayer, engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts | cell therapies | FDA | 2016-09-06 | — | Curtiss AG |
cultured skin substitute (CSS) | cell therapies | FDA | 2016-08-22 | — | Regenicin Inc. |
Sodium hypochlorite | small molecules | EMA | 2016-07-14 | — | Hypo-Stream Ltd |
Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts | cell therapies | EMA | 2015-12-14 | — | Yes Pharmaceutical Development Services GmbH |
Autologous Engineered Skin Substitute | cell therapies | FDA | 2012-06-01 | — | Amarantus BioScience Holdings, Inc. |
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat [StrataGraft] | cell therapies | FDA | 2012-05-21 | 2021-06-15 | Stratatech Corporation, a Mallinckrodt company |
Fibronectin Peptide | peptides | FDA | 2011-06-29 | — | NeoMatrix Therapeutics, Inc. |
N'-(5-chloro-2-hydroxy-3-methylbenzylidene)-2,4-dihydroxybenzhydrazide | small molecules | EMA | 2008-09-22 | — | Creative Antibiotics Sweden AB |
vibriolysin | proteins | FDA | 2006-06-16 | — | BioMarin Pharmaceutical Inc. |
anacaulase-bcbd [NexoBrid] | proteins | FDA | 2003-08-20 | 2024-08-15 | MediWound, Ltd. |
anacaulase-bcdb [NexoBrid] | other | FDA | 2003-08-20 | 2022-12-28 | Vericel Corporation |
Concentrate of proteolytic enzymes enriched in bromelain [NexoBrid] | proteins | EMA | 2002-07-30 | — | MediWound Germany GmbH |
Silver sulfadiazine and cerium nitrate | small molecules | FDA | 1999-11-17 | — | Alliance Pharmaceuticals Ltd |
Ananain, comosain | other | FDA | 1992-01-21 | — | Genzyme Corporation |
Poloxamer 188 | small molecules | FDA | 1990-02-22 | — | CytRx Corporation |
Somatropin (rDNA) | proteins | FDA | 1989-05-03 | — | EMD Serono, Inc. |
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