A Phase 2 interventional study of EHSG-KF and STSG in Skin Wound, sponsored by CUTISS AG. Completed at 7 sites in 3 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by CUTISS AG · Phase 2, Interventional, and Treatment
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →CUTISS AG is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Location A is the experimental area and Location B is the control area.
Biological: EHSG-KF · Biological: STSG
Location A is the control area and Location B is the experimental area.
Biological: EHSG-KF · Biological: STSG
Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
Also known as: denovoSkin
Transplantation of autologous split-thickness skin graft to the control area
Also known as: Split-thickness skin graft
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).
Time frame: 3 months post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Observer Total Score
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score
Time frame: 3 months and 1 year +/- 30 days post grafting
A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,.
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation
Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area.
Time frame: 28 +/- 3 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.
Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take
Time frame: 4-11 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory")
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Patient Observer Scar Assessment Scale")
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("EuroQuol 5 dimensions questionnaire")
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief")
Time frame: 1 +/- 30 days year post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.
Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation.
Time frame: 4-11 days and 19-23 days post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.
Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events.
Time frame: through study completion, an average of 3 years
Plan to share: No
Ran from Feb 2018 to primary completion in Dec 2023, 69 months.
Of 24 phase 2 interventional studies under Cicatrix, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 61. This study's 69 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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CUTISS AG