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

HAN Guan-ya; WU Xiao-li; LI Dong-mei; CAI Hai-rui; ZHOU Jun-jun; HE Xiao-bo

doi:10.1007/s11655-023-3730-0

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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

Original Article | Updated：2023-05-25

- Chinese Medicine Plaster as A New Treatment for Surgical Site Infection in Patients with Cesarean Delivery: A Randomized, Double-Blind, Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 29, Issue 6, Pages: 483-489(2023)
- Affiliations：
  
  1.Department of Obstetrics, Ningbo Women and Children's Hospital, Ningbo, Zhejiang Province (315012), China
  2.Department of Medical Intensive Care Unit, Ningbo Women and Children's Hospital, Ningbo, Zhejiang Province (315012), China
- Author bio：
  
  Dr. HAN Guan-ya, E-mail: hanguanya@sina.cn
- Funds：
- DOI：10.1007/s11655-023-3730-0
  CLC：
- Published：2023-06，
  
  Published Online：26 March 2023，
  
  Accepted：10 June 2022
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HAN Guan-ya, WU Xiao-li, LI Dong-mei, et al. Chinese Medicine Plaster as A New Treatment for Surgical Site Infection in Patients with Cesarean Delivery: A Randomized, Double-Blind, Controlled Trial. [J]. Chinese Journal of Integrative Medicine 29(6):483-489(2023)
DOI：

HAN Guan-ya, WU Xiao-li, LI Dong-mei, et al. Chinese Medicine Plaster as A New Treatment for Surgical Site Infection in Patients with Cesarean Delivery: A Randomized, Double-Blind, Controlled Trial. [J]. Chinese Journal of Integrative Medicine 29(6):483-489(2023) DOI： 10.1007/s11655-023-3730-0.

摘要

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)

. 17.21% (47/274)

0.01]. The durution of postoperative antibiotic intake was shorter in the CM group than in the placebo group (

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

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)

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)

关键词

Keywords

Chinese medicine plasterrhubarb and mirabilitesurgical site infectioncesarean deliveryrandomized controlled trial

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