[SavageGlow]

An allegedly-four day-old neonate, born by home delivery by an apparently psychotic mother, was referred to a regional Italian pediatric burn center and immediately recovered on the neonatal intensive care unit (NICU). Since non-accidental injury was strongly suspected, both parents were arrested, and no reliable medical history was available. The newborn, weighing 3.5 kg, demonstrated 40 % TBSA full-thickness skin lesions (scalp, face, chest, abdomen, both legs), looking like chemical burns (Fig. 1). Also, a hypochlorite-like smell was noted, and the baby therefore immediately washed under running water and dressed with polyurethane foam.

The patient was stabilized, intubated, cannulated (vein and artery), and monitored (respiratory, cardiac, and neurologic). Seizures and cardiac arrhythmias of unknown origin were successfully treated with i.v. medication. Due to the extended full-thickness skin lesions and the impossibility to harvest enough of the very thin skin from remaining uninjured areas without the risk of creating deep skin defects requiring grafting, the team decided for an innovative solution, i.e. using bioengineered autologous skin. The Pediatric Plastic Surgeon in charge, contacted the Pediatric Burn Center of the University Children’s Hospital Zurich, Switzerland, asking support by means of cultured Zurich Skin for this patient. This request was approved, and the decision made to produce and eventually apply Zurich Skin.

A Swiss-Italian task force was installed. Within one week, in close collaboration with the Italian Regulatory authority Agenzia Italiana del Farmaco (AIFA), the local ethics committees (EC) of the hospital (A.O.R.N.A. Cardarelli-Santobono Comitato Etico), and the hospital administration, all necessary documents were prepared, and a sub-study was developed within the ongoing phase II clinical trial (NCT03229564) to allow formal recruitment of this patient and subsequent treatment with Zurich Skin. Following AIFA and EC approval, the clinical site was activated as official study center. After consent for the procedures by the legal representative of the patient, the process for Zurich Skin manufacturing was initiated according to the study protocol.

A 4 cm2 skin biopsy was harvested from the right axillary region on post burn day 10 (PBD-10) and sent by dedicated courier to CUTISS Inc., Zurich, for culturing of Zurich Skin. Manufacturing was performed in a Good Manufacturing Practice (GMP)-certified clean-room facility of the Wyss Zurich Translational Center, University of Zurich, Switzerland, as previously published [8]. In short, keratinocytes and fibroblasts were isolated from the skin biopsy and expanded in vitro. Thereafter, fibroblasts were combined with a collagen type I hydrogel, and after an initial cultivation phase, keratinocytes were seeded onto the hydrogel surface. After an additional cultivation period, grafts were shipped by dedicated courier (Good Distribution Practice, GDP) to the clinical site. Grafts were released by the manufacturer’s Qualified Person, as well as the EU Qualified Person responsible for the release of Zurich Skin. Manufacturing was performed in two runs, two plus five for a total of seven grafts. The receipt, control of the transport conditions, check of grafts after transport, unpackaging and handling of grafts was performed by the local team with live video assistance of the Zurich team.

Due to the unforeseen emergency circumstances, we could not rely on and make use of an established telemedicine system managing essential regulatory and legal aspects [[9], [10], [11], [12]]. Travelling on site for the Zurich medical team was not possible due to COVID-19 restrictions. We orchestrated, however, all telemedicine communication and online action to the best of our possibilities to ascertain maximal data safety and confidentiality. With the establishment of the telemedicine communication, assistance, advice, instruction, and other help during the operations could be “produced” and perceived live, and eventual modifications could be achieved instantly if necessary.

From admission, the baby underwent serial necrosectomies on the first four consecutive days in hospital. Resection down to fat or fascia was necessary to remove the partly liquefied necrotic tissue, presumably colliquation necrosis. On PBD-4, at the age of eight days, all defects were covered with Integra® Dermal Regeneration Template (IDRT) (Fig. 2) in order to stabilise the patient. IDRT was chosen as autograft harvesting would have been technically extremely difficult and would have added new wounds to a patient already in critical condition. Twenty days after the biopsy, i.e. on PBD-30, two Zurich Skin grafts (mean size each 25 cm2) were transplanted onto the abdomen (Fig. 3). Six days later, on PBD-36, another five cultured Zurich Skin grafts (mean size each 42 cm2) were transplanted onto the chest and abdomen (Fig. 4), thereby covering about half of the defects with a total of 260 cm2 (corresponding to 20 % TBSA). The above two sessions of Zurich Skin transplantations were performed with telemedicine assistance. The coordinating study investigator was connected online with the operating theatre via Zoom (Fig. 3) and was so able to supervise the operations and comment the procedures in a satisfactory, albeit not ideal way (instable internet). At the second grafting session (transplantation of 5 grafts, sized about 42 cm2), the first two grafts appeared frail and viability was questionable in some spots (Fig. 4), yet, later they recovered and epithelialized completely. The remaining defect areas were covered with autologous skin grafts, harvested from the posterior trunk, using the Meek technique (expansion ratio 1:3) on PBD-44. No infections were observed.

[Mr.NoCredit]

Jesus fucking Christ what is wrong with people that would do that to an infant.

Send to Mexico so they can have their faces removed with a knife by some coked out cartel member.

[SavageGlow]

Originally Posted by Mr.NoCredit ↗

Jesus fucking Christ what is wrong with people that would do that to an infant.

Send to Mexico so they can have their faces removed with a knife by some coked out cartel member.

I absolutely agree.

[HIGHTECHDUDE]

Same applies to mothers...

[jenna_live]

And yet if the child survives they won't remember the actual intention. Only being reminded of it by people in place of it care. Great opportunity to enforce abortion for mentally unable. & those deemed unfit. Lol as if

[Pyramid_Head]

How could you do this to a child, let alone your own child???

[Caveman5150]

"Zurich Skin" ...PEOPLE -- They hyper-grew the kids own skin, in a lab, from a tiny sample piece & patched it back on him like it was homemade... holy dogshit man. 25 years ago that would be a dead baby from infections....wow

[Jimntrix]

Somebody needs to die! Or have the same thing done to them over and over.

[Boneshaker]

the mentally unstable parents should be skinned alive. seems just, in this case.

[Vulpes Inculta]

Poor, sweet baby :(