The Wound Infection After Stomy Closure Between Different Methods of Drainage

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03994354
Collaborator
(none)
66
1
36
1.8

Study Details

Study Description

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 Phase
  • Procedure: J-P drainage and cutaneous penrose drainage insertion

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
1,2

J-P drain group 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.

Outcome Measures

Primary Outcome Measures

  1. Wound infection [Wound infection in post-operation 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Shuang-Ho Hospital New Taipei City Taiwan 235

Sponsors and Collaborators

  • Taipei Medical University Shuang Ho Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jun 21, 2019
Last Update Posted:
Oct 22, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2020