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

External Application of Traditional Chinese Medicine Mirabilite for the Prevention of Incisional Complications and Promotion of Gastrointestinal Function Recovery in Gastrointestinal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Gastrointestinal Surgery; Postoperative Gastrointestinal Dysfunction; Mirabilite
• Intervention / Treatment: Procedure: Topical Mirabilite Application for Postoperative Gastrointestinal Patients; Procedure: Standard Postoperative Care for Gastrointestinal Patients

Detailed Description

This single-center randomized controlled trial investigates the efficacy of Mirabilite in enhancing postoperative outcomes for patients undergoing gastrointestinal surgery, with a specific focus on individuals receiving abdominal incisions for gastrointestinal malignancies. Abdominal surgeries often lead to complications such as incision fat liquefaction, surgical site infections (SSI), and postoperative gastrointestinal dysfunction, issues for which traditional treatment methods have shown limited success. This study aims to assess Mirabilite's potential therapeutic advantages in this context.

Mirabilite, a mineral widely used in traditional Chinese medicine, possesses properties that facilitate swelling reduction, pain relief, and tissue repair, attributed to its high osmotic pressure. Approximately 300 participants are randomly allocated to either a Mirabilite intervention group or a standard postoperative care group. In the intervention group, Mirabilite is applied topically to surgical incisions, with subsequent evaluations focusing on incision healing, gastrointestinal function recovery, and markers of inflammation.

Primary endpoints include incision healing duration, time to first flatus, SSI incidence, postoperative pain scores, and hospital length of stay. This trial seeks to substantiate the role of Mirabilite as a cost-effective and safe adjunct therapy for postoperative recovery in gastrointestinal surgery, with the potential to reduce hospital stays and mitigate complication rates.

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • NanChang, Jiangxi, China, 330000
      • The First Affiliated Hospital of NanChang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirabilite Application Group; 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; 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.
Sham Comparator: Standard Care Group; Participants will receive standard postoperative care with regular sterile dressing changes, without additional topical treatments.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-Reactive Protein (CRP) Levels (mg/L)	CRP levels as an inflammatory marker.	Measured on postoperative days 1, 4, and 7.
Visual Analog Scale (VAS) Pain Scores	Patient-reported pain levels on a 10-cm VAS scale (0 = no pain, 10 = worst pain).	Recorded on postoperative days 1, 2, and 3.
Daily Drainage Volume (mL)	Total daily output from drainage tubes, indicating postoperative exudation and inflammation.	Measured daily from postoperative days 1 through 7.
Postoperative Serum Protein Levels (g/L)	Serum protein levels, reflecting nutritional status and recovery.	Measured on postoperative days 1 and 4.
Length of Postoperative Hospital Stay (Days)	Total duration of hospital stay post-surgery.	1 day after operation
Operative Time (Minutes)	Duration of the surgical procedure.	Recorded on the day of surgery.
Incision Length (cm)	Length of the surgical incision made during the procedure.	Measured on the day of surgery.
Surgical Type	Classification of the surgical procedure type	Recorded on the day of surgery.
Intraoperative Blood Loss (mL)	Total volume of blood lost during the procedure.	Measured on the day of surgery.

Collaborators and Investigators

• Sponsor: Nanchang University
• Investigators: Study Chair: Ye ShanPing Dr. Ye, Department of General Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, Jiangxi Province, China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Surgical Wound Infection
• Other Study ID Numbers: IIT2024323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No