Vaginal reconstruction such as Mayer-Rokitansky-Kuster-Hauser ?Vaginal atresia? Vulvovaginal trauma and Benign tumor of vulva
Conditions
Interventions
Experimental group:SIS tissue repair materials
control group:Cook-Soft tissue patch
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Women aged 18 to 50 years; 2) Patients who intend to undergo vaginal repair or reconstruction, including Mayer-Rokitansky-Kuster-HauserVaginal atresia, Vulvovaginal trauma and Benign tumor of vulva; 3) Patients who can communicate well with researchers; 4) Informed consent, voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Women during pregnancy; 2) Patients with malignant tumors; 3) Class III and above cardiac function; 4) ECG examination revealed the following abnormalities: premature contraction, atrial flutter, atrial fibrillation, ventricular tachycardia, and hemodynamically unstable malignant arrhythmia; 5) Blood IgG or blood IgA or blood IgM is more than 1.5 times ULN; ALT or AST or BUN or PT is more than 1.5 times ULN; 6) Patients with unconsciousness, mental illness or severe mental illness; 7) Patients with contraindications to the use of pig-derived products; 8) Patients who have participated in other clinical trials within 30 days before the date of signing or signing the informed consent form; 9) The investigator believes that other patients are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal length >=8cm;The width of the cavity can easily accommodate 2 fingers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Colposcopy confirms mucosalization of tissue at the repair site;Product performance evaluation; | — |
Countries
China
Contacts
Public ContactJianhua Liu
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed