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Chinese Medicine Plaster as A New Treatment for Surgical Site Infection in Patients with Cesarean Delivery: A Randomized, Double-Blind, Controlled Trial

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Abstract

Objective

To evaluate the efficacy of Chinese plaster containing rhubarb and mirabilite on surgical site infection (SSI) in patients with cesarean delivery (CD) by performing a randomized controlled trial.

Methods

This randomized controlled trial included 560 patients with CD due to fetal head descent enrolled at a tertiary teaching center between December 31, 2018 and October 31, 2021. Eligible patients were randomly assigned to a Chinese medicine (CM) group (280 cases) or a placebo group (280 cases) by a random number table, and were treated with CM plaster (made by rhubarb and mirabilite) or a placebo plaster, respectively. Both courses of treatment lasted from the day 1 of CD, followed day 2 until discharge. The primary outcome was the total number of patients with superficial, deep and organ/space SSI. The secondary outcome was duration of postoperative hospital stay, antibiotic intake, and unplanned readmission or reoperation due to SSI. All reported efficacy and safety outcomes were confirmed by a central adjudication committee that was unaware of the study-group assignments.

Results

During the recovery process after CD, the rates of localized swelling, redness and heat were significantly lower in the CM group than in the placebo group [7.55% (20/265) vs. 17.21% (47/274), P<0.01]. The durution of postoperative antibiotic intake was shorter in the CM group than in the placebo group (P<0.01). The duration of postoperative hospital stay was significantly shorter in the CM group than in the placebo group (5.49 ± 2.68 days vs. 8.96 ± 2.35 days, P<0.01). The rate of postoperative C-reactive protein elevation (≽100 mg/L) was lower in the CM group than in the placebo group [27.6% (73/265) vs. 43.8% (120/274), P<0.01]. However, there was no difference in purulent drainage rate from incision and superficial opening of incision between the two groups. No intestinal reactions and skin allergies were found in the CM group.

Conclusions

CM plaster containing rhubarb and mirabilite had an effect on SSI. It is safe for mothers and imposes lower economic and mental burdens on patients undergoing CD. (Registration No. ChiCTR2100054626)

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Acknowledgments

We thank those who have devoted much to this study, including nurses, study doctors, statisticians, reviewers, and editors, especially Dr. HU Min. They were not financially compensated for their contributions.

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Authors and Affiliations

  1. Department of Obstetrics, Ningbo Women and Children’s Hospital, Ningbo, Zhejiang Province, 315012, China

    Guan-ya Han

  2. Department of Medical Intensive Care Unit, Ningbo Women and Children’s Hospital, Ningbo, Zhejiang Province, 315012, China

    Xiao-li Wu, Dong-mei Li, Hai-rui Cai, Jun-jun Zhou & Xiao-bo He

Authors
  1. Guan-ya Han
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  2. Xiao-li Wu
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  3. Dong-mei Li
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  4. Hai-rui Cai
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  5. Jun-jun Zhou
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  6. Xiao-bo He
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Contributions

Han GY: data collection, manuscript writing; Li DM and Wu XL: data collection and data analysis; He XB: project development and manuscript editing. All the authors reviewed and approved the final version of the manuscript for publication.

Corresponding author

Correspondence to Guan-ya Han.

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Conflict of Interest

The authors declare no conflicts of interest.

Supported by the Natural Science Foundation of Ningbo, China (No. 2019A610312) and the Project of Ningbo Leading Medical & Health Discipline, China (No. 2010-S04)

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Han, Gy., Wu, Xl., Li, Dm. et al. Chinese Medicine Plaster as A New Treatment for Surgical Site Infection in Patients with Cesarean Delivery: A Randomized, Double-Blind, Controlled Trial. Chin. J. Integr. Med. 29, 483–489 (2023). https://doi.org/10.1007/s11655-023-3730-0

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  • DOI: https://doi.org/10.1007/s11655-023-3730-0

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