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Completed

NCT Number: NCT06696729

External Application of Mirabilite to Promote Recovery in Patients After 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.

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Key information

Conditions

Gastrointestinal Surgery Infections Mirabilite Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Gastrointestinal Dysfunction Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Incidence of Complications (%)

    Time frame: Within 30 days post-surgery

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

  2. Incidence of Surgical Site Infection (SSI) (%)

    Time frame: Within 30 days post-surgery

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

  3. Time to First Flatus (Days)

    Time frame: 1 day after operation

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

Secondary outcomes

  1. C-Reactive Protein (CRP) Levels (mg/L)

    Time frame: Measured on postoperative days 1, 4, and 7.

    CRP levels as an inflammatory marker.

  2. Visual Analog Scale (VAS) Pain Scores

    Time frame: Recorded on postoperative days 1, 2, and 3.

    Patient-reported pain levels on a 10-cm VAS scale (0 = no pain, 10 = worst pain).

  3. Daily Drainage Volume (mL)

    Time frame: Measured daily from postoperative days 1 through 7.

    Total daily output from drainage tubes, indicating postoperative exudation and inflammation.

  4. Postoperative Serum Protein Levels (g/L)

    Time frame: Measured on postoperative days 1 and 4.

    Serum protein levels, reflecting nutritional status and recovery.

  5. Length of Postoperative Hospital Stay (Days)

    Time frame: 1 day after operation

    Total duration of hospital stay post-surgery.

  6. Operative Time (Minutes)

    Time frame: Recorded on the day of surgery.

    Duration of the surgical procedure.

  7. Incision Length (cm)

    Time frame: Measured on the day of surgery.

    Length of the surgical incision made during the procedure.

  8. Surgical Type

    Time frame: Recorded on the day of surgery.

    Classification of the surgical procedure type

  9. Intraoperative Blood Loss (mL)

    Time frame: Measured on the day of surgery.

    Total volume of blood lost during the procedure.

Sponsors and collaborators

Lead sponsor

Nanchang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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