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

NCT06696729 | Completed

• 1 other identifier: IIT2024323
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Incidence of Complications (%)

  The overall incidence of postoperative complications, including any adverse events directly related to the surgery.

  Within 30 days post-surgery

• Incidence of Surgical Site Infection (SSI) (%)

  The incidence rate of surgical site infections, categorized as superficial or deep infections at the incision site.

  Within 30 days post-surgery

• Time to First Flatus (Days)

  The duration in days from surgery to the first passage of flatus, indicating the resumption of gastrointestinal motility.

  1 day after operation

Secondary Outcomes (9)

• C-Reactive Protein (CRP) Levels (mg/L)

  Measured on postoperative days 1, 4, and 7.

• Visual Analog Scale (VAS) Pain Scores

  Recorded on postoperative days 1, 2, and 3.

• Daily Drainage Volume (mL)

  Measured daily from postoperative days 1 through 7.

• Postoperative Serum Protein Levels (g/L)

  Measured on postoperative days 1 and 4.

• Length of Postoperative Hospital Stay (Days)

  1 day after operation

Study Arms (2)

Mirabilite Application Group

EXPERIMENTAL

Participants will receive a 500-gram external application of Mirabilite on the abdominal incision site, replaced regularly to maintain efficacy.

Procedure: Topical Mirabilite Application for Postoperative Gastrointestinal Patients

Standard Care Group

SHAM COMPARATOR

Participants will receive standard postoperative care with regular sterile dressing changes, without additional topical treatments.

Procedure: Standard Postoperative Care for Gastrointestinal Patients

Interventions

Topical Mirabilite Application for Postoperative Gastrointestinal Patients PROCEDURE

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.

Mirabilite Application Group

Standard Postoperative Care for Gastrointestinal Patients PROCEDURE

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.

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent gastrointestinal surgery. Aged between 18 and 80 years. Provided signed informed consent.

You may not qualify if:

• Required unplanned surgical intervention within 30 days postoperatively. Presented with emergency conditions, such as bowel obstruction or gastrointestinal bleeding, or diagnosed with severe psychiatric disorders.
• Underwent surgical procedures for advanced malignancies, including palliative or bypass surgeries.
• Classified as American Society of Anesthesiologists (ASA) Physical Status \> 3. Requested withdrawal from the study after enrollment. Demonstrated non-compliance or utilized mirabilite for fewer than three consecutive days.
• Experienced unexpected discharge during the study period.

Sponsors & Collaborators

• Nanchang University: lead

Study Sites (1)

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ye ShanPing Dr. Ye

  Department of General Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, Jiangxi Province, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 20, 2024
• Study Start: October 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 31, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)