Evidence map›Paper›PMID 38861260›Full record

Trial reportJAMA network open2024

Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial.

Yating Wei, Yi Li, Xiaojian Li, Yaohua Zhao, Junci Xu, Haitao Wang, Xinzhou Rong, Junlin Xiong, Xiaodong Chen, Gaoxing Luo and 32 more

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in JAMA network open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06189638 (A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild Infections of Diabetic Foot Ulcers), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06189638 phase2active not recruitingnot on this map

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Antimicrobial Peptide PL-5 Topical Spray in Patients With Mild Infections of Diabetic Foot Ulcers

TypeinterventionalSponsorJiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.Ran2024 to 2027Enrolled90ConditionsDiabetic Foot UlcersArmsAntimicrobial Peptide PL-5 Topical Spray and Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

42 authors.

Yating WeiDepartments of Burn and Plastic Surgery and Wound Repair, the First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, China.
Yi LiQinghai University Affiliated Hospital, Xining, China.
Xiaojian LiGuangzhou Red Cross Hospital, Guangzhou, China.
Yaohua ZhaoJiangyin People's Hospital, Jiangyin, Wuxi, China.
Junci XuHuizhou Municipal Central Hospital, Huizhou, China.
Haitao WangWeihai Municipal Hospital, Weihai, China.
Xinzhou RongGuangzhou First People's Hospital, Guangzhou, China.
Junlin XiongGanzhou Municipal Hospital, Ganzhou, China.
Xiaodong ChenThe First People's Hospital of Foshan, Foshan, China.
Gaoxing LuoThe Southwest Hospital, Chongqing, China.
Guozhong LvAffiliated Hospital of Jiangnan University, Wuxi, China.
Cai LinThe First Affiliated Hospital of Wenzhou Medical University, New District of the First Hospital of Wenyi Hospital, Wenzhou, China.
Chunmao HanThe Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China.
Hongliang YuYuncheng Central Hospital, Yuncheng, China.
Yi ZhangAffiliated Hospital of Nantong University, Nantong, China.
Shijie TangThe Second Affiliated Hospital of Shantou University Medical College, Shantou, China.
Youfen FanNingbo Huamei Hospital of University of the Chinese Academy of Sciences, Ningbo, China.
Jiajin TuGanzhou People's Hospital, Ganzhou, China.
Chengde XiaZhengzhou First People's Hospital, Zhengzhou, China.
Hongxu ZuThe First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Wenjun LiuThe Second Affiliated Hospital of Kunming Medical University, Kunming, China.
Chang LiuAffiliated Hospital of Jiangsu University, Zhenjiang, China.
Jinhui LiuJilin Province People's Hospital, Changchun, China.
Baolin ZhangFirst Hospital of Shanxi Medical University, Taiyuan, China.
Qingwen NongThe First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Tianyu LiNanshi Hospital of Nanyang, Nanyang, China.
Lei WangZhongda Hospital Southeast University, Nanjing, China.
Guodong SongJinan Central Hospital, Jinan City, China.
Yongtao SuPeking University Care Luzhong Hospital, Zibo, China.
Zhaohong ChenFujian Medical University Union Hospital, Fuzhou, China.
Wen LaiGuangdong Provincial People's Hospital, Guangzhou, China.
Yanjie FuLinyi People's Hospital, Linyi, China.
Jia'ao YuThe First Hospital of Jilin University, Changchun, China.
Pihong ZhangXiangya Hospital of Central South University, Changsha, China.
Weixi YangThe Affiliated Huaian No. 1 People Hospital of Nanjing Medical University, Huaian, China.
Gang YaoThe First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Hongyan ZhangThe First Affiliated Hospital of Nanchang University, Nanchang, China.
Kunwu FanDepartments of Burn and Plastic Surgery and Wound Repair, the First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, China.
Hu DongJiangsu Protelight Pharmaceutical & Biotechnology Co, Ltd, Jiangyin, China.
Yuxin ChenJiangsu Protelight Pharmaceutical & Biotechnology Co, Ltd, Jiangyin, China.
Jun WuDepartments of Burn and Plastic Surgery and Wound Repair, the First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen, China.
PL-5 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: Peceleganan spray is a novel topical antimicrobial agent targeted for the treatment of skin wound infections. However, its efficacy and safety remain unclear. Objective: To assess the safety and efficacy of peceleganan spray for the treatment of wound infections. Design, Setting, and Participants: This multicenter, open-label, phase 3 randomized clinical trial recruited and followed up 570 adult patients diagnosed with secondary open wound infections from 37 hospitals in China from August 23, 2021, to July 16, 2022. Interventions: Patients were randomized to 2 groups with a 2:1 allocation. One group received treatment with 2% peceleganan spray (n = 381) and the other with 1% silver sulfadiazine (SSD) cream (n = 189). Main Outcomes and Measures: The primary efficacy outcome was the clinical efficacy rate (the number of patients fulfilling the criteria for efficacy of the number of patients receiving the treatment) on the first day following the end of treatment (day 8). The secondary outcomes included the clinical efficacy rate on day 5 and the bacterial clearance rate (cases achieving negative bacteria cultures after treatment of all cases with positive bacteria cultures before treatment) on days 5 and 8. The safety outcomes included patients' vital signs, physical examination results, electrocardiographic findings, blood test results, and adverse reactions. Results: Among the 570 patients randomized to 1 of the 2 groups, 375 (98.4%) in the 2% peceleganan treatment group and 183 (96.8%) in the 1% SSD control group completed the trial (n = 558). Of these, 361 (64.7%) were men, and the mean (SD) age was 48.6 (15.3) years. The demographic characteristics were similar between groups. On day 8, clinical efficacy was achieved by 339 patients (90.4%) in the treatment group and 144 (78.7%) in the control group (P < .001). On day 5, clinical efficacy was achieved by 222 patients (59.2%) in the treatment group and 90 (49.2%) in the control group (P = .03). On day 8, bacterial clearance was achieved by 80 of 334 patients (24.0%) in the treatment group and in 75 of 163 (46.0%) in the control group (P < .001). On day 5, bacterial clearance was achieved by 55 of 334 patients (16.5%) in the treatment group and 50 of 163 (30.7%) in the control group (P < .001). The adverse events related to the application of peceleganan spray and SSD cream were similar. Conclusions and Relevance: This randomized clinical trial found that peceleganan spray is a safe topical antimicrobial agent with a satisfactory clinical efficacy rate for the treatment of skin wound infections, while the effectiveness of bacterial clearance remains uncertain. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2100047202.

Indexed as

Wound InfectionAdultAgedAnti-Bacterial AgentsAnti-Infective Agents, LocalChinaFemaleHumansMaleMiddle AgedSilver SulfadiazineTreatment OutcomeAnti-Bacterial AgentsAnti-Infective Agents, LocalSilver Sulfadiazine

Identifiers

PMID38861260
PMCPMC11167495

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.