An interventional study of Topical Mirabilite Application for Postoperative Gastrointestinal Patients and Standard Postoperative Care for Gastrointestinal Patients in Gastrointestinal Surgery, Mirabilite and Surgical Site Infection, sponsored by Nanchang University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Nanchang University · Not applicable, Interventional, and Treatment
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.
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 301 is above the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
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Exclusion Criteria:
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.
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 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 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.
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.
Incidence of Complications (%)
The overall incidence of postoperative complications, including any adverse events directly related to the surgery.
Time frame: 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.
Time frame: 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.
Time frame: 1 day after operation
C-Reactive Protein (CRP) Levels (mg/L)
CRP levels as an inflammatory marker.
Time frame: 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).
Time frame: Recorded on postoperative days 1, 2, and 3.
Daily Drainage Volume (mL)
Total daily output from drainage tubes, indicating postoperative exudation and inflammation.
Time frame: Measured daily from postoperative days 1 through 7.
Postoperative Serum Protein Levels (g/L)
Serum protein levels, reflecting nutritional status and recovery.
Time frame: Measured on postoperative days 1 and 4.
Length of Postoperative Hospital Stay (Days)
Total duration of hospital stay post-surgery.
Time frame: 1 day after operation
Operative Time (Minutes)
Duration of the surgical procedure.
Time frame: Recorded on the day of surgery.
Incision Length (cm)
Length of the surgical incision made during the procedure.
Time frame: Measured on the day of surgery.
Surgical Type
Classification of the surgical procedure type
Time frame: Recorded on the day of surgery.
Intraoperative Blood Loss (mL)
Total volume of blood lost during the procedure.
Time frame: Measured on the day of surgery.
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Nanchang University