Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery (Dressing)

February 28, 2026 updated by: Dazhi Xu, Fudan University

A Randomized, Open-Label, Multicenter, Non-Inferiority Clinical Trial Comparing No Wound Dressing Change Versus Routine Wound Dressing Change After Gastrointestinal Surgery

The goal of this randomized non-inferiority trial is to evaluate whether omitting postoperative wound dressings is noninferior to routine dressing changes in patients undergoing gastrointestinal cancer surgery. The main questions it aims to answer are:

  1. Is omitting dressings noninferior to routine dressing changes in preventing a composite of wound complications requiring clinical intervention?
  2. Can omitting dressings reduce postoperative pain and eliminate dressing-related costs?

Participants diagnosed with gastrointestinal tumors undergoing elective surgery will be randomly assigned to either the non-dressing group or the routine dressing group. The non-dressing group will have their initial dressing removed at 48 hours postoperatively, with no further coverage or disinfection unless clinically indicated. The dressing group will receive standardized dressing changes every 48 hours until suture removal at 7-14 days. Researchers will compare the two groups regarding the rate of wound complications, pain scores, and total dressing-related costs.

This study aims to provide evidence-based recommendations for minimalist postoperative wound care, potentially improving patient comfort and reducing unnecessary medical expenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research Objectives and Design:

This study is a prospective, multicenter, randomized, open-label, parallel-group, non-inferiority trial. The primary objective is to demonstrate that omitting routine dressing changes is noninferior to standard care for preventing a composite of wound complications within 30 days after gastrointestinal cancer surgery. Secondary objectives are to compare postoperative pain scores and total dressing-related costs between the two strategies.

Inclusion Criteria and Sample Size:

A total of 1138 patients aged 18 to 75 years who underwent elective gastrointestinal surgery for histologically confirmed malignancies were enrolled and randomized. Key inclusion criteria included an ECOG Performance Status of 0 or 1. Key exclusion criteria included active skin disorders at the incision site, uncontrolled comorbidities, prior abdominal radiotherapy, recent immunosuppressive therapy, or inability to complete follow-up, as detailed in the protocol.

Study Methodology:

Participants were randomly assigned in a 1:1 ratio to either the non-dressing group or the routine dressing group. In the non-dressing group, the initial dressing was removed 48 hours postoperatively, with no further disinfection, cleansing, or wound coverage unless specific clinical indications arose (e.g., purulent discharge, extensive erythema). In the routine dressing group, patients received standardized dressing changes every 48 hours, consisting of disinfection with 10% povidone-iodine and application of a new sterile dressing, until suture removal at 7-14 days postoperatively. All wound complications were adjudicated by an independent, blinded Endpoint Committee using standardized photographic evidence.

Follow-up and Outcomes:

Follow-up assessments were conducted every other day before discharge and at postoperative days 14 and 30. The primary outcome was the composite incidence of postoperative wound complications requiring clinical intervention within 30 days after surgery (incisional SSI, fat liquefaction, hematoma, wound dehiscence, or delayed healing). Secondary outcomes included individual complication rates, pain scores measured by Visual Analog Scale (VAS, 0-10) on postoperative days 2, 4, and 6, and total dressing-related costs.

Statistical Analysis:

The primary analysis was performed on the intention-to-treat population. Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval for the risk difference (non-dressing minus dressing) was below the prespecified margin of +6%. The non-inferiority hypothesis was tested with a one-sided alpha of 0.025.

Study Type

Interventional

Enrollment (Actual)

1138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Changhai Hospital, Naval Medical University
      • Shanghai, Shanghai Municipality, China, 2000000
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200003
        • Changzheng Hospital, Navy Medical University
      • Shanghai, Shanghai Municipality, China, 200120
        • Shanghai East Hospital, School of Medicine, Tongji University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged between 18 and 75 years.
  2. Having undergone elective gastrointestinal surgery for gastrointestinal cancer (histologically confirmed) within the past 24 hours.
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  4. Possessing sufficient cognitive ability to understand the study protocol and voluntarily signing a written informed consent form.

Exclusion Criteria:

  1. Presence of significant barriers to completing postoperative follow-up (e.g., severe sensory/cognitive impairment, inability to adhere to follow-up plan, lack of reliable contact methods, residence >6 hours from study center).
  2. Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site.
  3. History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment.
  4. Current diagnosis of any other uncontrolled severe comorbid conditions (e.g., uncontrolled other malignant tumors, acute or persistent chronic infections) that may pose additional risks or confound study outcomes.
  5. Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period.
  6. Current long-term or high-dose use of systemic corticosteroids or any other medications that may significantly affect wound healing (topical/inhaled/low-dose steroids allowed if assessed by investigator).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-Dressing Group
Participants in this group received standard wound disinfection and initial sterile dressing immediately after surgery. At 48 hours postoperatively, the initial dressing was removed. No further disinfection, cleansing, or wound coverage was performed unless specific clinical indications arose. The incision remained exposed until suture removal at 7-14 days postoperatively. This arm evaluates whether omitting routine dressing changes is noninferior to standard care in preventing wound complications.
Procedure: Non-Dressing of Surgical Wound
Participants received standard wound disinfection and initial sterile dressing immediately after surgery. At 48 hours postoperatively, the initial dressing was removed. Unless specific clinical indications arose (e.g., purulent discharge, extensive erythema), no further disinfection or wound coverage was performed. The incision remained exposed until suture removal at 7-14 days postoperatively. This intervention evaluates the noninferiority of omitting routine dressing changes in terms of wound complications, pain reduction, and cost savings.
Active Comparator: Dressing Group
Participants in this group received standard postoperative care. Their surgical wounds were covered with dressings immediately after surgery, and these dressings were changed every 48 hours (including disinfection and reapplication of dressing) until suture removal at 7-14 days postoperatively. This group serves as the comparator for assessing the non-dressing approach.
Procedure: Regular Dressing Change of Surgical Wound
This intervention involves standard postoperative wound care. After surgery, wounds were disinfected and covered with dressings. Dressings were changed every 48 hours (with disinfection and reapplication) until suture removal (7-14 days postoperatively), following traditional wound management practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of composite wound complications within 30 days after surgery
Time Frame: Within 30 days after surgery

This is a composite endpoint including surgical site infection, wound dehiscence, hematoma/seroma requiring intervention, fat liquefaction, and delayed wound healing, each of which necessitated additional medical intervention. The non-inferiority of the "no dressing change" strategy versus the "routine dressing change" strategy will be tested using the Farrington-Manning test. The pre-specified non-inferiority margin (Δ) is 6%. Non-inferiority will be established if the upper limit of the two-sided 95% confidence interval for the difference in incidence rates (no dressing change minus routine dressing change) is below 6%.

Time Frame: Up to 30 days after surgery.
Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: Postoperative days 2, 4, and 6
Pain intensity measured using the Visual Analog Scale (VAS), a 0-10 scale with higher scores indicating greater pain. Assessments are performed at rest by trained research staff.
Postoperative days 2, 4, and 6
Total Dressing-Related Costs
Time Frame: From the time of surgery up to 30 days post-surgery
Direct costs calculated from the hospital perspective using standardized fee schedules. Total cost per patient includes three components: (1) material costs (primary sterile dressing), (2) nursing procedure fees for each dressing change (classified as minor, intermediate, or major according to the National Catalog of Medical Service Prices), and (3) any additional treatment costs incurred due to management of wound complications.
From the time of surgery up to 30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Changhai Hospital
Shanghai East Hospital
Shanghai Changzheng Hospital
School of Public Health，Fudan University

Investigators

  • Principal Investigator: Dazhi Xu, MD, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dressing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD that will be shared includes de-identified participant data encompassing demographic information, clinical data, and study outcomes. Supporting documents include the study protocol, statistical analysis plan, and informed consent form. All shared data will be de-identified to protect participant privacy and confidentiality. Researchers accessing the data will be required to provide a methodologically sound proposal and sign a data access agreement that includes a commitment to using the data only for research purposes and not attempting to identify individual participants.

IPD Sharing Time Frame

IPD and supporting information will be available upon publication of the main study results and will remain accessible for five years.

IPD Sharing Access Criteria

Data access will be granted to researchers who provide a methodologically sound proposal submitted to the corresponding author for review by the study team. Data will be shared after both parties have executed a signed data access agreement. Researchers must commit to using the data only for research purposes and not to attempt to re-identify individual participants.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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