Clinical trial NCT06263205: Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
Official title: Clinical Investigation of Wound Management Following Gastrointestinal Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastrointestinal Tumors
Surgical Wound Infection
Pain, Postoperative
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
name: Changhai Hospital
name: Shanghai East Hospital
First posted: 2024-02-16
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Rate of Postoperative Wound Healing Complications
timeFrame: Up to 30 days post-surgery
Secondary outcomes:
measure: Patient Pain Levels
timeFrame: From the time of surgery up to 30 days post-surgery
measure: Medical Costs Associated with Wound Care
timeFrame: From the time of surgery up to 30 days post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Dazhi Xu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
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