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CompletedNCT00597662Updated Jun 10, 2008

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

A Phase 1 interventional study of polylactide-caprolactone-trimethylenecarbonate copolymer and Icodextrin 4% in Adhesions, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-06-10.

Sponsored by University Hospital Tuebingen · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

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Conditions studied

  • Adhesions

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03

In context

Tissue Adhesions

241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.

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Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    Device: polylactide-caprolactone-trimethylenecarbonate copolymer

  • Active comparator
    2

    Device: Icodextrin 4%

Interventions

  • Devicepolylactide-caprolactone-trimethylenecarbonate copolymer

    Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum

  • DeviceIcodextrin 4%

    1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation

06

What researchers measure

Primary outcomes

  1. Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission

    Time frame: 3 months

Secondary outcomes

  1. Use of analgesia

    Time frame: 1, 2 and 3 days

  2. Post-operative pyrexia

    Time frame: 3 months

  3. Post-operative infection

    Time frame: 3 months

  4. Requirement for re-operation

    Time frame: 3 months

  5. Dysmenorrhoea

    Time frame: 3 months

  6. Dyspareunia

    Time frame: 3 months

  7. Constipation

    Time frame: 3 months

  8. Diarrhoea

    Time frame: 3 months

  9. Nausea

    Time frame: 3 months

  10. Duration of adhesion prophylaxis

    Time frame: Day 1

  11. Usability as assessed by surgeon

    Time frame: Day 1

07

Study locations

1 site
  • Universitäts-Frauenklinik Tübingen
    Tübingen, Baden-Wuerttemberg 72076, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00597662
Lead sponsor
University Hospital Tuebingen
First posted
Jan 18, 2008
Start date
Jan 2008
Primary completion
Apr 2008
Last update
Jun 10, 2008

Study contacts

Diethelm Wallwiener, Prof. Dr.
study chair · Universitäts-Frauenklinik Tübingen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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