The Wound Infection After Stomy Closure Between Different Methods of Drainage

Taipei Medical University Shuang-Ho Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: J-P drainage and cutaneous penrose drainage insertion

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound infection	Wound infection in post-operation 30 days

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2019
• Primary Completion (Anticipated): July 7, 2022
• Study Completion (Anticipated): July 7, 2022

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: N201905015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No