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

Adhesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597662
• Other study ID #: SUP-002
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2008
• Last updated: June 9, 2008
• Start date: January 2008

Study information

• Verified date: June 2008
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Tübingen
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adhesions
• Tissue Adhesions

Intervention

Device:
• polylactide-caprolactone-trimethylenecarbonate copolymer
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
• Icodextrin 4%
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation

Locations

Country	Name	City	State
Germany	Universitäts-Frauenklinik Tübingen	Tübingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission		3 months	Yes
Secondary	Use of analgesia		1, 2 and 3 days	Yes
Secondary	Post-operative pyrexia		3 months	Yes
Secondary	Post-operative infection		3 months	Yes
Secondary	Requirement for re-operation		3 months	Yes
Secondary	Dysmenorrhoea		3 months	Yes
Secondary	Dyspareunia		3 months	Yes
Secondary	Constipation		3 months	Yes
Secondary	Diarrhoea		3 months	Yes
Secondary	Nausea		3 months	Yes
Secondary	Duration of adhesion prophylaxis		Day 1	No
Secondary	Usability as assessed by surgeon		Day 1	No