Postoperative Adhesion
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:nDM-14R
Dose form / Japanese Medical Device Nomenclature:DEVICE
absorbable adhesion barrier
Route of administration / Site of application:INTRAPERITONEAL
Sponsors
Kawasumi. laboratory .inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients of 20 years or more at the time of obtaining informed consent. (2) Patient who will have covering colostomy and colostomy closure. (3) Patient or legal representative who well understand the protocol with written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patient scheduled for first-stage laparoscopic surgery. (2) Patient who need intraperitoneal injection of perfusate of drugs that affect on adhesion formation during 24 hours to 7 days after first-stage surgery. (3) Patient who have had previous abdominal median incision. (4) Cancer patient of stageIV. (5) Patient with ECOG Performance Status over 3. (6) Patient with a history of severe drug allergy. (7) Patient with an allergy to materials of investigational device. (8) Patient with body-wide infection. (9) Patient who wish to become pregnant during the study or pregnant, lactating. (10) Patient from the course of the disease, life expectancy less than one year. (11) Participation in other clinical studies either concurrently or within the last three months. (12) Patient who were deemed inappropriate as the subject of clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence or absence of post operation adhesion | — |
Secondary
| Measure | Time frame |
|---|---|
| Adhesion area / adhesion grade | — |
Countries
Japan
Contacts
Public ContactToshiyasu Yuba
Kawasumi. laboratory. Inc
Outcome results
None listed