The Wound Infection After Stomy Closure Between Different Methods of Drainage

Wound Infection Clinical Trial

Official title:

Taipei Medical University Shuang-Ho Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03994354
• Other study ID #: N201905015
• Status: Active, not recruiting
• Start date: July 6, 2019
• Est. completion date: July 7, 2022

Study information

• Verified date: October 2020
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound infection		Wound infection in post-operation 30 days