Clinical Investigation of Wound Management Following Gastrointestinal Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are: 1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques? 2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs. This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≤ 75 years.

• Scheduled to undergo gastrointestinal surgery for gastrointestinal cancer (pathologically confirmed).

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

• Possesses sufficient cognitive ability to understand the study protocol and voluntarily signs a written informed consent form.

Locations
Other Locations
China
Changhai Hospital, Naval Medical University
RECRUITING
Shanghai
Changzheng Hospital, Navy Medical University
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shanghai East Hospital, School of Medicine, Tongji University
RECRUITING
Shanghai
Contact Information
Primary
Dazhi Xu, MD, PhD
xudzh@shca.org.cn
86-18121299796
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2029-04-01
Participants
Target number of participants: 1138
Treatments
Experimental: Non-Dressing Group
Participants in this group will receive standard wound disinfection and dressing immediately after gastrointestinal tumor surgery. At 48 hours post-surgery, the dressing will be removed and the wound will be left exposed without any disinfection or reapplication of dressing. This state will be maintained until suture removal at 7-14 days postoperatively. This arm aims to evaluate the outcomes when the surgical wound is kept exposed, in contrast to traditional dressing methods.
Active_comparator: Dressing Group
Participants in this group will receive standard postoperative care. Their surgical wounds will be covered with dressings immediately after surgery, and these dressings will be changed every 48 hours (including disinfection and reapplication of dressing) until suture removal at 7-14 days postoperatively. This group serves as the comparator for assessing the non-dressing approach.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Changzheng Hospital, Shanghai East Hospital, Changhai Hospital
Leads: Fudan University

This content was sourced from clinicaltrials.gov