None listed
Conditions
Interventions
Drug : The study will be progressed the two groups as belows. And please refer to the following investigational product drug information.
- Experimental product vs placebo comparator(18 numbers)
- Exp
Sponsors
Eyegene
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) arbitrary participation informed consent volunteer 2) 19~75 years when screening 3) the patient who need skin graft because of trauma, ulcer, burns, surgery incision defect 4) the patient who can give the following the skin graft donor site (1) location: both sides leg similar location or ipsilateral(if ipsilateral donor site, the maxium distance= 3cm) leg skin graft donor site (2) 0.008~0.012 inch (0.20~0.30mm) split-thickness skin grafts (STSG) (3) if the following size was content with criteria: ? 2 skin graft donor site areas are similar(permission within 25% difference) ? 2 skin graft donor site areas 38~127cm2(25% difference consideration) (4) if the skin graft donor site which the previous skin graft donor site didn't give
Exclusion criteria
Exclusion criteria: 1) active systemic infection or over 38? fever lasted 3 days within 1 week before inject investigaional product 2) the severity of disease excluded diabetes(immune deficiency syndrom, arteriosclerosis obliterans, variceal) could be influenced wound recovery 3) the patient who couldn't regulate blood sugar of HbA1c= 8.5% or severe diabetes complication 4) B or C type hepatitis patient(exclusion healthy carrier) or evidence of HIV(Human Immunodeficiency Virus) 5) thyroid cancer(stage I, II papillary, follicular, medullary types), basal cell or squamous cell carcinoma not metastasize in skin, CIN and CIS of cervix, other site malignancy tumor medical history within 3 years excluded intraepithelial carcinoma 6) hypersensitivity reaction anamnesis 7) the patient didn't progress the fix period received the prohibited drug or therapy before clinical trial 8) the patient who injecting the comcomitant prohibied drugs 9) creatinine > 1.5 x ULN(upper limit of Normal) 10) ALT >3 x ULN(upper limit of Normal) 11) Total bilirubin > 3 x ULN(upper limit of Normal) 12) Plasma Albumin 1.5 x UNL(upper limit of Normal) (2) the patient is relevant to the following category as the patient are injecting anticoagulant(e.g. warfarin or LMW heparin) ? active bleeding or hemorrhage inclination highly (e.g.: anamnesis aneurysm patient) ? target INR(2~3) couldn't maintain although injection the stable dose 14) smoker didn't stop smoking within clinical trial 15) the anamnesis patient who drink and other drug abuse before screening 6 months 16) the patient who contingently have the injection experience of psychotropic substances, narcotic analgesics before screening 6 months 17) the psychosis or other central nerve patient who couldn't proceed the clinical trial by investigator judgment 18) communication impossible patient 19) the patient who have low understanding clinical trial or no willingness to visit or already scheduled elective surgery by investigator judgement 20) pregnant woman or no willingness to stop breast-feeding 21) Not included the following criteria(in other words, the patient can participate if the following are relevent) (1) menopause(non-therapy-induced amenorrhea over 12 months) woman (2) infertility because of surgery(ovary or have no uterus) woman (3) if man who have no any semen after man-infertility surgery have sexual relationship only one partner (4) if pregnancy could be woman, woman who use the effective contraception as below. ? oral contraception ? contraception patch ? intrauterine device(IUD) ? contraception implant ? contraception injection(controlled-relaese) ? uterus hormone device ? tubal ligation and infertility surgery (5) woman who agreed the abstinence within clinical trial ? the experience which the patient definitely have abstinence during all period ? excluded the intermittent abstinence(e.g.: ovulation, symptothermal, after ovulation) or external ejaculation 22) the patient who participate present participating or within 30 days after previous participation 23) other unsuitable cases by investigator judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 100% re-epithelialization or not and lead time in experimental product and comparator by investigator judgement | — |
Secondary
| Measure | Time frame |
|---|---|
| re-epithelialization area ratio(%) injected in experimental product and comparator;re-epithelialization velocity(re-epithelialization area(%)/ lead time(day));50% re-epithelialization lead time(day);100% re-epithelialization or not by investigator judgement;100% re-epithelialization or not by judging the photos in skin graft donor site;blister formation or breakdown occurrence patient ratio after 100% re-epithelialization;exudate occurence frequency and ratio in injected experimental product and comparator;exudate occurence aspect in injected experimental product and comparator | — |
Countries
Korea, Republic of
Contacts
Public ContactHyung Min Han
Ajou University Hospital
Outcome results
None listed