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

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. 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.

Conditions

• Gastrointestinal Tumors
• Surgical Wound Infection
• Pain, Postoperative

Interventions

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.

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.

Sponsors & Collaborators

• Shanghai East Hospital

  collaborator OTHER

• School of Public Health，Fudan University

  collaborator UNKNOWN

• Changhai Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Fudan University

  lead OTHER

Principal Investigators

• Dazhi Xu, MD, PhD · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2025-07-30

Completion

2025-07-30

Countries

• China

Study Locations