Pain, Postoperative Clinical Trial
— DressingOfficial title:
Clinical Investigation of Wound Management Following Gastrointestinal Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
Verified date | March 2024 |
Source | Fudan University |
Contact | Dazhi Xu, MD, PHD |
Phone | 02164175590 |
xudzh[@]shca.org.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 816 |
Est. completion date | December 24, 2026 |
Est. primary completion date | January 24, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Changhai Hospital, Shanghai Changzheng Hospital, Shanghai East Hospital |
China,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Postoperative Wound Healing Complications | 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. | Up to 30 days post-surgery | |
Secondary | Patient Pain Levels | 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. | From the time of surgery up to 30 days post-surgery | |
Secondary | Medical Costs Associated with Wound Care | 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. | From the time of surgery up to 30 days post-surgery |
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