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External Application of Mirabilite to Promote Recovery in Patients After Gastrointestinal Surgery

NCT06696729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-11-22

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of topical Mirabilite (sodium sulfate) application for managing postoperative outcomes in patients undergoing gastrointestinal cancer surgery. Conducted at the First Affiliated Hospital of Nanchang University, this randomized controlled trial assesses Mirabilite's potential to mitigate postoperative complications, including surgical site infections and abdominal distention, and to expedite the recovery of gastrointestinal function. Participants are randomly assigned to either a Mirabilite treatment group or a standard care control group. Follow-up assessments, extending up to five years, will examine incision healing, complication incidence, and metrics of gastrointestinal recovery to provide robust evidence on the clinical benefits of Mirabilite in surgical settings.

Conditions

  • Gastrointestinal Surgery
  • Mirabilite
  • Surgical Site Infection
  • Postoperative Gastrointestinal Dysfunction

Interventions

PROCEDURE

Topical Mirabilite Application for Postoperative Gastrointestinal Patients

Participants in this group will receive an external application of 500 grams of Mirabilite (sodium sulfate decahydrate) beginning on postoperative day 1. The Mirabilite will be wrapped in a double layer of gauze and placed on top of the sterile dressing over the patient's abdominal incision, with the gauze bag secured by an abdominal binder. The application will be regularly replaced when it becomes damp and hardened to maintain continuous efficacy.

PROCEDURE

Standard Postoperative Care for Gastrointestinal Patients

Participants in this group will receive standard postoperative care without the application of Mirabilite or any alternative topical treatment. Their surgical sites will be kept dry and clean, with regular sterile dressing changes as part of standard care protocols.

Sponsors & Collaborators

  • Nanchang University

    lead OTHER

Principal Investigators

  • Ye ShanPing Dr. Ye · Department of General Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, Jiangxi Province, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-04-30
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06696729 on ClinicalTrials.gov