Treatment of the head and neck region with HD-AM

JRCT ID: jRCTs042200040

Registered date:28/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: ear disease, sinonasal disease, pharyngeal and laryngeal diseases
• Date of first enrollment: 01/04/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

[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 draping, skin is incised from superior to inferior.
3) The musculoperiosteal layer is cut from the area of the superior edge of the external auditory canal toward the posterior edge of the skin incision. The flap is detached from bone.
4) In mastoidectomy, drilling is carried out with a cutting burr.
5)Facial ridge, and the anterior attachment of the facial ridge is drilled.
6) It is removed the pathological tissues (like cholesteatoma) from mastoid and tympanic cavity.
7) After removal the pathological tissues, it is covered with HD amniotic membrane to mastoid and tympanic cavity.
8)It is sutured the retroaulicular incision with nylon thread.

(1)Myringoplasty
1)The edge of perforation is refreshed.
2)It is covered with HD amniotic membrane on the perforation.

(2)Skin graft on the auricle
1)It is removed the pathological tissues (cancer etc.,) with cartilage membrane from the auricle.
2)It is taken the skin for graft from the arm( or somewhere).
3)It is covered with HD amniotic membrane on the cartilage.
4)After covering HD amniotic membrane, skin graft is performed on HD amniotic membrane.
5)This graft is sutured with the auricle skin.
6)It is compressed with gauze.

[ Nose, paranasal sinus disease]
(1) Maxillary antrum tumor
1) After a general anesthesia, 1% Xylocaine injections -"1:100,000" epirenamine component (AstraZeneca Co.) infiltration anesthesia.
2) Incesion of the upper gingiva on the diseased side is made, then the piriform aperture and anterior wall of the maxilla are exposed.
3) Anterior wall of the maxilla is resected, then tumor and mucosa in the maxillary sinus are peeled off from superior and lateral wall of the maxillary sinus.
4) Medial wall of the maxillary sinus, inferior turbinate, mucosa of the piriform aperture and nasolacrimal duct are resected en-bloc with tumor and mucosa in the maxillary sinus.
5) HD amnion membrane is put on the raw bony surface of nasal cavity and maxillary sinus.
6) Hemostatic materials are put on the wounded area.
7) Incised mucosa of upper gingiva is sutured.

(2) Nasal cavity tumor
1) After a general anesthesia, 1% Xylocaine injections -"1:100,000" epirenamine component (AstraZeneca Co.) infiltration anesthesia.
2) Mucosal incision of the nasal cavity is set around the tumor with more than 5mm safety margin.
3) Tumor with periosteum is resected.
4) HD amnion membrane is put on the raw bony surface of nasal cavity.
5) Hemostatic materials are put on the wounded area.

(3) Hypertrophic rhinitis, allergic rhinitis
1) After a general anesthesia, 1% Xylocaine injections -"1:100,000" epirenamine component (AstraZeneca Co.) infiltration anesthesia.
2) Endoscopic resection or laser cauterization of inferior turbinate is performed.
3) hemostatic procedure is made and HD amnion membrane is put on the inferior turbinate.
4) Hemostatic materials are put on the wounded area.

(4) Refractory frontal sinusitis, frontal sinus cyst, frontal sinus tumor
1) After a general anesthesia, 1% Xylocaine injections -"1:100,000" epirenamine component (AstraZeneca Co.) infiltration anesthesia.
2) Bilateral endoscopic anterior ethmoidectomies are performed.
3) Bilateral endoscopic posterior ethmoidectomies are performed.
4) Bilateral endoscopic sphenoidotomies are performed.
*3) or 4) surgical procedures are skipped if subject does not have posterior ethmoiditis or sphenoiditis, respectively.
5) Bilateral endoscopic maxillary sinusotomies are performed.
*5) surgical procedure is skipped if subject does not have maxillary sinusitis or lesion.
6) The window of the nasal septum anterior to the middle turbinate is made.
7) Bilateral mucosa of agger nasi are resected, then bilateral bone of the agger nasi are drilled out.
8) Bone of the frontal beak is drilled out as widely as possible and bilateral frontal sineses are opened to nasal cavity.
9) Frontal septum and lesions in the frontal sinuses are removed as much as possible.
10) HD amnion membrane is put on the raw bony surface of the frontal sinuses.
11) Hemostatic materials are put on the wounded area.

[Oral and laryngopharyngeal diseases]
1) After a general anesthesia, 1% Xylocaine injections -"1:100,000" epirenamine component (AstraZeneca Co.) infiltration anesthesia.
2) After draping, develop an appropriate operation field with an retractor or laryngoscope.
3) Remove the lesion.
4) Perform hemostasis operation.
5) Cover and fix the wound surface with HD amniotic membrane.
6) Pull out the retractor or laryngoscope.
7) Measure the size of the wound surface.

Outcome(s)

Primary Outcome

(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 Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takakura Hiromasa