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

NCT ID: NCT06696729

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-10-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirabilite Application Group

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

Group Type: EXPERIMENTAL

Topical Mirabilite Application for Postoperative Gastrointestinal Patients

Intervention Type: 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.

Standard Care Group

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

Group Type: SHAM_COMPARATOR

Standard Postoperative Care for Gastrointestinal Patients

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Taiyuan Li

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ye ShanPing Dr. Ye

Role: STUDY_CHAIR

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

Locations

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

IIT2024323

Identifier Type: -

Identifier Source: org_study_id