Trial Title:
Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
NCT ID:
NCT06263205
Condition:
Gastrointestinal Tumors
Surgical Wound Infection
Pain, Postoperative
Conditions: Official terms:
Wound Infection
Surgical Wound Infection
Digestive System Neoplasms
Gastrointestinal Neoplasms
Pain, Postoperative
Wounds and Injuries
Surgical Wound
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Non-Dressing of Surgical Wound
Description:
In this intervention, participants undergoing gastrointestinal tumor surgery will receive
standard wound disinfection and initial postoperative care, which includes the
application of dressings immediately after surgery. However, unlike traditional methods,
the dressings will be removed 48 hours post-surgery, and the surgical wounds will then be
left exposed without any further dressing. This method is intended to evaluate the
effects of an exposed surgical wound on healing, pain, and healthcare costs, compared to
traditional dressing methods.
Arm group label:
Non-Dressing Group
Intervention type:
Procedure
Intervention name:
Regular Dressing Change of Surgical Wound
Description:
This intervention involves the standard postoperative wound care for participants with
gastrointestinal tumors. After surgery, the surgical wounds will be disinfected and
covered with dressings. These dressings will be changed every 48-72 hours, following
traditional wound management practices. The purpose of this intervention is to serve as a
comparator for assessing the effectiveness of the non-dressing approach, focusing on
wound healing, pain management, and healthcare costs.
Arm group label:
Dressing Group
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.
Detailed description:
Research Objectives and Design:
This study is a prospective, randomized controlled trial primarily aimed at comparing the
efficacy of wound healing between non-dressing and dressing methods post-gastrointestinal
tumor surgery. The secondary objective is to evaluate the effectiveness of the
non-dressing approach in reducing postoperative pain and medical expenses.
Inclusion Criteria and Sample Size:
The study plans to enroll 212 patients aged 75 years or younger, diagnosed pathologically
with gastrointestinal tumors and scheduled for curative surgery or open gastrointestinal
bypass surgery. Participants must have an ECOG (Eastern Cooperative Oncology Group)
performance status score of 0/1 and be capable of understanding and signing the informed
consent. Exclusion criteria include inability to complete postoperative follow-up,
ineligibility for surgical treatment, concurrent skin diseases, history of abdominal
trauma or surgery, other uncontrolled severe diseases, ongoing other cancer treatments,
and current use of drugs that may affect wound healing.
Study Methodology:
Participants will be randomly assigned to one of two groups: a non-dressing group (Group
A) and a dressing group (Group B). Group A will have dressings removed 48 hours
post-surgery and keep the wound exposed unless signs of infection are present. Group B
will undergo regular dressing changes every 48 to 72 hours until sutures are removed
between the 7th and 14th postoperative days. Both groups will be closely monitored for
wound treatment and complications such as fat liquefaction, infection, and wound
dehiscence.
Withdrawal/Early Termination Criteria:
Patients may withdraw from the study voluntarily at any time. Researchers can also decide
to withdraw a patient if continued treatment is deemed not in the patient's best
interest. Reasons for withdrawal include but are not limited to other concurrent
diseases, death, relapse, complications, receiving non-study treatments, or patient's
request to exit the study.
Follow-up Plan:
The study will conduct stringent follow-ups, including observation and assessment of the
surgical wound 30 days post-surgery, recording the frequency of dressing changes, total
costs, pain scores, and wound comfort levels. The follow-up endpoints include patient
withdrawal, change in treatment modality, disease progression, death, or reaching the
study's end date.
Observation and Evaluation during the Trial:
All trial procedures must be preceded by obtaining informed consent approved by an
ethical committee. All data collected during the trial will be statistically analyzed
following the intention-to-treat principle.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≤ 75 Years: Participants must be 75 years old or younger.
2. Pathologically Confirmed Gastrointestinal Tumor: All participants must have a
pathological diagnosis of a gastrointestinal tumor, including but not limited to
stomach, colon, and rectal cancers.
3. Undergoing Curative Surgery for Gastrointestinal Tumor or Open Gastrointestinal
Bypass Surgery: Eligible for inclusion are those scheduled for curative resection or
necessary open bypass surgery of the gastrointestinal tract.
4. ECOG Performance Status 0/1: Participants should have an ECOG (Eastern Cooperative
Oncology Group) performance status score of 0 or 1, indicating they are fully active
or restricted in physically strenuous activity but ambulatory and able to carry out
light or sedentary work.
5. Able to Understand and Sign Informed Consent: Participants must be capable of
understanding the written informed consent and willing to sign it.
Exclusion Criteria:
1. Unable to Complete Postoperative Follow-up: Patients who are unable to comply with
the required postoperative follow-up.
2. Ineligible for Surgical Treatment: Patients who are not candidates for surgical
intervention.
3. Concurrent Skin Disease: Patients with skin diseases that could affect wound
healing, such as psoriasis or eczema.
4. History of Abdominal Trauma or Surgery Leading to Deformity or Scar Formation:
Patients with a history of abdominal trauma or previous surgery that resulted in
deformity or significant scarring.
5. Severe Uncontrolled Comorbid Conditions: Patients with severe, uncontrolled comorbid
conditions, including but not limited to other active cancers, acute infections, or
chronic unhealed infections.
6. Currently Undergoing Other Cancer Treatments: Patients who are receiving any other
form of cancer treatment, including chemotherapy, radiation therapy, biological
therapy, or immunosuppressive therapy.
7. Use of Steroids or Other Medications Affecting Wound Healing: Patients currently
using steroids or other medications that might interfere with wound healing.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
2000000
Country:
China
Contact:
Last name:
Dazhi Xu, MD,PHD
Phone:
021-64175590
Email:
xudzh@shca.org.cn
Start date:
April 1, 2024
Completion date:
December 24, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
Changhai Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai East Hospital
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263205
