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

Nanchang University

Status: Completed

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

Treatments: Procedure: Standard Postoperative Care for Gastrointestinal Patients; Procedure: Topical Mirabilite Application for Postoperative Gastrointestinal Patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06696729

IIT2024323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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301 participants in 2 patient groups

Mirabilite Application Group

Experimental group

Description:

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

Treatment:

Procedure: Topical Mirabilite Application for Postoperative Gastrointestinal Patients

Standard Care Group

Sham Comparator group

Description:

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

Treatment:

Procedure: Standard Postoperative Care for Gastrointestinal Patients