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

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.

Study Overview

• Status: Completed
• Conditions: Adhesions
• Intervention / Treatment: Device: polylactide-caprolactone-trimethylenecarbonate copolymer; Device: Icodextrin 4%

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Tübingen, Baden-Wuerttemberg, Germany, 72076
      • Universitats-Frauenklinik Tubingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: polylactide-caprolactone-trimethylenecarbonate copolymer; Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
Active Comparator: 2	Device: Icodextrin 4%; 1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Use of analgesia	1, 2 and 3 days
Post-operative pyrexia	3 months
Post-operative infection	3 months
Requirement for re-operation	3 months
Dysmenorrhoea	3 months
Dyspareunia	3 months
Constipation	3 months
Diarrhoea	3 months
Nausea	3 months
Duration of adhesion prophylaxis	Day 1
Usability as assessed by surgeon	Day 1

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Study Chair: Diethelm Wallwiener, Prof. Dr., Universitats-Frauenklinik Tubingen

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (Estimate): January 18, 2008

Study Record Updates

• Last Update Posted (Estimate): June 10, 2008
• Last Update Submitted That Met QC Criteria: June 9, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Pharmaceutical Solutions; Dialysis Solutions; Icodextrin
• Other Study ID Numbers: SUP-002