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The Wound Infection After Stomy Closure Between Different Methods of Drainage

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ClinicalTrials.gov Identifier: NCT03994354
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Tungcheng Chang, Taipei Medical University Shuang Ho Hospital

Brief Summary:

This proposal will investigate the wound condition between different drainage methods of the stoma closure wound. Anastomotic leakage is a major complication after colorectal surgery. The protective stoma will decrease the anastomosis leakage rate and severity1. Stoma closure is often performed after the condition of the previous protecting site improved. Wound infection is not a rare complication after stoma closure, with a reported infectious rate from 3% to 43%. Wound infection will result in wound dehiscence, incisional herniation, ileus and the length of hospital stay. Lots of the stoma wound closure technique have been developed, including subcutaneous antibiotic material implantation, wound irrigation with iodine, closure wound with a drain tube, secondary closure, delayed primary closure and pursestring closure. But there still is in a debate about the best skin closure test. In Division of Colorectal Surgery Shuang Ho Hospital, two current stoma wound closure methods were subcutaneous Jackson-Pratt drainage and cutaneous Penrose drainage insertion.

In the project, clinical outcomes of these two drainage methods will be compared. The subcutaneous. Jackson-Pratt drainage is used to create negative pressure in subcutaneous closure wound. The negative pressure will extract actively the tissue debris and fluid, avoiding the seroma and pus accumulation. The cutaneous Penrose drainage is used to create delayed skin healing, and the tissue debris and fluid will drainage passive by capillary phenomenon. Two groups will be distributed randomly. The demographic characters like age, gender, BMI, nutritional status, under chemotherapy, diabetes and past medication history will be reviewed. Perioperative clinical data like the method of the anastomosis, operation time, postoperative hospital day, surgical site infection, prolonged ileus, anastomosis leakage, and incisional hernia will be collected.

From this study, these two stoma wound closure methods will be evaluated and analyze the risk factors of complication for the stoma wound closure.


Condition or disease Intervention/treatment
Wound Infection Procedure: J-P drainage and cutaneous penrose drainage insertion

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Taipei Medical University Shuang-Ho Hospital
Actual Study Start Date : July 6, 2019
Estimated Primary Completion Date : July 7, 2022
Estimated Study Completion Date : July 7, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1,2
  1. J-P drain group
  2. Penrose drain group
Procedure: J-P drainage and cutaneous penrose drainage insertion
Lots of the stoma wound closure technique have been developed, including subcutaneous antibiotic material implantation, wound irrigation with iodine, closure wound with a drain tube, secondary closure, delayed primary closure and pursestring closure. But there still is in debate about best skin closure test. In Division of Colorectal Surgery Shuang Ho Hospital, two current stoma wound closure methods were subcutaneous Jackson-Pratt drainage and cutaneous penrose drainage insertion.




Primary Outcome Measures :
  1. Wound infection [ Time Frame: Wound infection in post-operation 30 days ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient who had suffered from colostomy or ileostomy in previous operation will be enrolled in this study.
Criteria

Inclusion Criteria:

  • Patients suffered from colon or ileum stoma. After the doctor's evaluation, the distal bowel tract was normal.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994354


Contacts
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Contact: Tung-cheng Chang, PhD +886-2-22490088 ext 8123 roussekimo@yahoo.com.tw

Locations
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Taiwan
Taipei Medical University Shuang-Ho Hospital Recruiting
New Taipei City, Taiwan, 235
Contact: Tung-Cheng Chang, PhD    +886-2-22490088 ext 8123    roussekimo@yahoo.com.tw   
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
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Responsible Party: Tungcheng Chang, Chief of colorectal surgery, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03994354    
Other Study ID Numbers: N201905015
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Wound Infection