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Treatment of the head and neck region with HD-AM

Surgical reconstruction using the hyper dry human drying amniotic membrane (HD-AM) of the otolaryngology field - SHDAMO

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042200040
Enrollment
60
Registered
2020-08-28
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ear disease, sinonasal disease, pharyngeal and laryngeal diseases

Interventions

[Ear disease] (1)Cholesteatoma 1) After a general anesthesia, 1% Xylocaine solution with "1:100,000" epirenamine component (AstraZeneca Co.) is injected the planned retro-auricular incision. 2) After

Sponsors

Morita Yuka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)age, The patients who relatively have good Patient. 2)overall status of(at the agreement acquisition)20 years old or older. (ECOG Performance Status is more than level 2.) 3) [Ear disease] (1)Cholesteatoma Patients who were operated for canal wall down tympanoplasty (without reconstruction of canal wall,or packing mastoid). (2)Myringoplasty Patients who have tympanic perforation. (3)Skin graft on the auricle Patients who have the auricle disease(carcinoma,etc.). [sinonasal diseases] (1)maxillary tumor Adult patients who will receive a partial maxillectomy for the maxillary tumor. (2)nasal cavity tumor Patients who will receive the endoscopic resection for the nasal cavity tumor. (3)Hypertrophic or Allergic rhinitis Patients who will receive the endoscopic turbinectomy or mucosal cauterization of the inferior turbinate for hypertrophic or allergic rhinitis. (4)Refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus. Patients who will receive the endoscopic modified Lothrop - Draf3 procedure for refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus. [Oral and laryngopharyngeal diseases] Patients who are scheduled to have mucous membrane or skin defect due to head and neck surgery. 4)The patients whom it is judged to be available for observation,the testing that conformed to a study enforcement plan and a survey.

Exclusion criteria

Exclusion criteria: 1) Ear disease (1)Cholesteatoma Patients who were operated for canal wall up tympanoplasty (with reconstruction of canal wall, or packing mastoid) (2)Myringoplasty & (3)Skin graft on the auricle Bellow 2) to 8) sinonasal diseases (1)maxillary tumor Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past (2)nasal cavity tumor Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past (3)Hypertrophic or Allergic rhinitis Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past (4)Refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past Oral and laryngopharyngeal diseases Patients who are considered not to be required to compensate for mucocutaneous defects due to the surgical procedure. 2)The patients whom a doctor judged safely for study period if it was difficult hospital visiting and to come home. 3)The patients who complicate eye infection with activity. 4)The patients who plan the enforcement of eye operations for evaluation eyes effective during study period in (we assume the agreement acquisition study initiation). 5)For the group medicine of the planned drug (Xylocaine anesthetic agent, Achromycin) to use during study period, it is the patient with a history of the drug allergy. 6)The patients (saying that, however, the subjects who do not receive the study drug are possible) who participated in other studies or clinical studies within six months. 7)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception. 8)The patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.

Design outcomes

Primary

MeasureTime frame
(1)Ear disease [Middle ear disease] "time to epithelization completion of the postoperative bony wall surface" In addition, the epithelization completion defines "the point in time when the summation of each item score became 0" as "epithelization completion" at each evaluation point of "pain, otorrhea, adhesion, color, the neovascularisation". [Ear drum perforation choke technique] "time to (epithelization) that a perforation choke is completed" [Skin grafting after the pinna skin lesions extraction] "Take (epithelization) of the skin grafting" (2)Nose, paranasal sinus disease "time to epithelization completion of the postoperative bony wall surface" In addition, the epithelization completion defines "the point in time when the summation of each item score became 0" as "epithelization completion" at each evaluation point of "pain, otorrhea, adhesion, color, the neovascularisation". (3)Oral laryngopharynx disease "time to epithelization completion of the postoperative mucosa defect"

Secondary

MeasureTime frame
(1)Ear disease:middle ear disease / ear drum perforation choke technique / pinna skin lesions extraction / (2)Nose, Paranasal sinus disease 1)pain 2)adhesion 3)color 4)neovascularisation 5)Impression degree questionnaire(it aims it to confirm a relationship with the objectivity endpoint)by the 5) patient (3)Oral laryngopharynx disease 1)oral intake situation 2)pain:using numerical rating scale (NRS) 3)trismus 4)tongue movement disorder 5)dysphonia 6)dysphagia 7)endoscope 1:Bleeding 2:Granulation hyperplasy of the wound margin 3:Adhesion of the HD amnion 4:Degradability of the HD amnion 5:Neovascularisation in the HD amnion 6:Progress of the epithelization 7:Stenotic degree 8:Behavior

Contacts

Public ContactMotonori Okabe

University of Toyama

okabe@med.u-toyama.ac.jp+81-76-434-7212

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026