Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Gastrointestinal Tumors; Surgical Wound Infection
• Interventions: Procedure: Non-Dressing of Surgical Wound; Procedure: Regular Dressing Change of Surgical Wound

• Registration Number: NCT06263205
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-31
• Study Start: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2026-01-24
• Study Completion: 2026-12-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 816

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Dressing Group	Non-Dressing of Surgical Wound	Participants in this group will receive standard wound disinfection and initial postoperative care with dressings applied immediately after their gastrointestinal tumor surgery. However, 48 hours post-surgery, these dressings will be removed and the wounds will be left exposed without any further dressing. This arm aims to evaluate the outcomes of wound healing, pain levels, and healthcare costs when the surgical wound is kept open postoperatively, in contrast to traditional dressing methods.
Dressing Group	Regular Dressing Change of Surgical Wound	Participants in this group will receive standard postoperative care, which includes regular wound dressings. Their surgical wounds will be covered with dressings, which will be changed every 48-72 hours following the surgery. This group serves as a comparator to assess the effectiveness and safety of the non-dressing approach in terms of wound healing, pain management, and associated healthcare costs.

Primary Outcome Measures

Name	Time	Method
Rate of Postoperative Wound Healing Complications	Up to 30 days post-surgery	This measure evaluates the overall incidence of poor wound healing after gastrointestinal tumor surgery, encompassing complications such as infection, fat liquefaction, and wound dehiscence. The effectiveness of non-dressing versus dressing methods in promoting wound healing will be determined by comparing the total percentage of patients experiencing any of these complications.

Secondary Outcome Measures

Name	Time	Method
Medical Costs Associated with Wound Care	From the time of surgery up to 30 days post-surgery	This measure evaluates the total medical costs associated with wound care following surgery. This includes the costs of dressings and the frequency of dressing changes. The aim is to compare these costs between the non-dressing and dressing groups to determine if non-dressing can help reduce healthcare expenses.
Patient Pain Levels	From the time of surgery up to 30 days post-surgery	This measure assesses the level of postoperative pain experienced by patients. Pain levels will be measured using a standardized pain scale (e.g., Visual Analogue Scale or VAS) and compared between the non-dressing and dressing groups to evaluate the impact of non-dressing on pain reduction.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China