A Randomized Control Study of Anti-Adhesion Agent After Colorectal Surgery

October 12, 2022 updated by: Tungcheng Chang, Taipei Medical University Shuang Ho Hospital

A Randomized Control Study of 4DryField PH Anti-Adhesion Agent After Colorectal Surgery

This project is to evaluate the difference of post-operation adhesion severity and adhesion area of patient received 4DryField after colorectal surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This proposal will investigate the effect of the newly anti-adhesive agent 4DryField. Stoma creation is common in complicated colorectal disease. Hartman procedure (End colostomy) is used in patients advanced rectal cancer or severe diverticulitis. Loop colostomy or ileostomy is used in patients need stool diversion for prevent leakage related infection.

4DryField is a powder consisting of sterile hydrophilic microparticles, which is anufactured from highly purified potato starch in a complex process. A unique starch-based medical device is 4DryField® PH (4DryField; PlantTec Medical GmbH, Germany) as it is the only product proven to provide hemostasis and prevent the formation of adhesions. In rat model, the 4DryField acheieve the significant adhesion prevention effectiveness. In gynecologic surgery, 4DryField showed effective adhesion prevention as confirmed at second look laparoscopy. The gel is easilier to applied in the uneven surface of pelvic cavity and peristomy area than other manufacture. The indication of adhesion prevention is approved by TFDA.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University Shuang-Ho Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing colorectal resection and temporary stoma

Exclusion Criteria:

  • - Pregnancy, child, psychiatric disorder, behavior disorder, and prisoner. And those patients can't follow the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Use 4DryField
One group use 4DryField before wound closure.
Device: Use 4DryField
Patients randomly use 4DryField in Colorectal resection combined with temporary stomy before fascia closure. We observed the adhesion severity and adhesion extent when stomy closure.
No Intervention: Not Use 4DryField
One group do not use 4DryField before wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesion severity
Time Frame: 0 days
Adhesion severity was scored as grade 0 (no adhesion), grade I (filmy adhesion and blunt dissection), grade II (strong adhesion and sharp dissection), and grade III (very strong vascularized adhesion, sharp dissection, and damage barely preventable)
0 days
Adhesion extent
Time Frame: 0 days
Adhesion area was scored as grade 0 (no adhesion), grade I (adhesion of less than one-third of the observational area), grade II (adhesion of one-third and two-thirds of the observational area), and grade III (adhesion of more than two-thirds of observational area ).
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 7-14 days
Number of days in hospital after surgery
7-14 days
Complication
Time Frame: 30 days
Complications within 30 days after surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Director: Tungcheng Chang, PhD, Taipei Medical University Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2022

Primary Completion (Anticipated)

September 4, 2024

Study Completion (Anticipated)

September 4, 2024

Study Registration Dates

First Submitted

October 9, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202106033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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