Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-01-15
Brief Title:
Wound Management Following Gl Tumor Surgery Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Clinical Investigation of Wound Management Following Gastrointestinal Tumor Surgery Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dressing
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
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 01 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
WithdrawalEarly 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 patients best interest Reasons for withdrawal include but are not limited to other concurrent diseases death relapse complications receiving non-study treatments or patients 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 studys 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
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 01 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
WithdrawalEarly 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 patients best interest Reasons for withdrawal include but are not limited to other concurrent diseases death relapse complications receiving non-study treatments or patients 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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None