The Wound Infection After Stomy Closure Between Different Methods of Drainage

NCT03994354 | Unknown DMC

• 1 other identifier: N201905015
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

• Wound infection

  Wound infection in post-operation 30 days

Study Arms (1)

1,2

1. J-P drain group 2. Penrose drain group

Procedure: J-P drainage and cutaneous penrose drainage insertion

Interventions

J-P drainage and cutaneous penrose drainage insertion PROCEDURE

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.

1,2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient who had suffered from colostomy or ileostomy in previous operation will be enrolled in this study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of colorectal surgery

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: July 6, 2019
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

TW (1)