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

NCT06263205 | Completed DMC

• 1 other identifier: Dressing
• Study Type: interventional
• Target: 1,138
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Gastrointestinal Tumors; Surgical Wound Infection; Pain, Postoperative

Keywords

Wound Dressing; Non-inferiority Trial; Gastrointestinal Neoplasms; Surgical Site Infection; Cost-effectiveness; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of composite wound complications 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 Outcomes (2)

• Postoperative Pain Score

  Postoperative days 2, 4, and 6

• Total Dressing-Related Costs

  From the time of surgery up to 30 days post-surgery

Study Arms (2)

Non-Dressing Group

EXPERIMENTAL

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

Dressing Group

ACTIVE COMPARATOR

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

Interventions

Non-Dressing of Surgical Wound PROCEDURE

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.

Non-Dressing Group

Regular Dressing Change of Surgical Wound PROCEDURE

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.

Dressing Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site.
• History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment.
• 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.
• Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period.
• 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).

Sponsors & Collaborators

• Fudan University: lead
• Shanghai East Hospital: collaborator
• School of Public Health，Fudan University: collaborator
• Changhai Hospital: collaborator
• Shanghai Changzheng Hospital: collaborator

Study Sites (4)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 2000000, China

Location

Changzheng Hospital, Navy Medical University

Shanghai, Shanghai Municipality, 200003, China

Location

Shanghai East Hospital, School of Medicine, Tongji University

Shanghai, Shanghai Municipality, 200120, China

Location

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (13)

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  PMID: 24470012 RESULT

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  PMID: 28049612 RESULT

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  PMID: 35261259 RESULT

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  PMID: 35267512 RESULT

MeSH Terms

Conditions

Digestive System Neoplasms; Surgical Wound Infection; Pain, Postoperative; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Gastrointestinal Diseases

Study Officials

• Dazhi Xu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and investigators were not masked to group assignment due to the visible nature of the intervention (presence or absence of dressing). The outcomes assessor (Endpoint Adjudication Committee) and study statisticians were masked throughout the trial using standardized photographic evidence and redacted clinical data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants were assigned in a 1:1 ratio to either the non-dressing group or the routine dressing group.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 16, 2024
• Study Start: April 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available upon publication of the main study results and will remain accessible for five years.
• 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.

Locations

CN (4)