Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis

University Hospital Tuebingen

Status and phase

Completed

Phase 1

Conditions

Adhesions

Treatments

Device: Icodextrin 4%

Device: polylactide-caprolactone-trimethylenecarbonate copolymer

Study type

Interventional

Funder types

Other

Identifiers

NCT00597662

SUP-002

Details and patient eligibility

About

The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 18-60 years
sex female
laparoscopic myomectomy indicated
ability and intention to conform to the study protocol
written informed consent

Exclusion criteria

pregnancy
indication for laparotomy
inflammatory bowel disease
additional surgical interventions
known or suspected intollerance or hypersensibility to the interventions
chronic pain
systemic corticoids or irradiation
alcohol abuse or other substance abuse
clinical signs of malignancy
psychiatric or neurological disease
participation in another clinical trial within 30 days
inability to understand the purpose of the trial or to conform to the study protocol
absence of written informed consent
inflammation of pelvic organs
presence of adhesions which lead to a conversion from laparoscopy to laparotomy
concurrent therapy with corticoids, anti-neoplastic agents or irradiation
maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics