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Observation on the effect of Ampelopsis Compound Gel compound on the postoperative wound after anal fistula surgery

Registration number：

ITMCTR2024000543

Date of Last Refreshed on：

2024-10-14

Date of Registration：

2024-10-14

Registration Status：

Retrospective registration

Public title：

Observation on the effect of Ampelopsis Compound Gel compound on the postoperative wound after anal fistula surgery

English Acronym：

Scientific title：

Observation on the effect of Ampelopsis Compound Gel compound on the postoperative wound after anal fistula surgery

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Dong Lidan

Study leader：

Zheng Xueping

Applicant telephone：

17785542346

Study leader's telephone：

17396209805

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2812372096@qq.com

Study leader's E-mail：

17720866044@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Nanjing Hospital of Traditional Chinese Medicine Daming Road Qinhuai District Nanjing Jiangsu Province China

Study leader's address：

Nanjing Hospital of Traditional Chinese Medicine Daming Road Qinhuai District Nanjing Jiangsu Province China

Applicant postcode：

210000

Study leader's postcode：

210000

Applicant's institution：

Nanjing Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY2023301

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Nanjing Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2023/10/27 0:00:00

Contact Name of the ethic committee：

Liu Zheng

Contact Address of the ethic committee：

Nanjing Hospital of Traditional Chinese Medicine Daming Road Qinhuai District Nanjing Jiangsu Province China

Contact phone of the ethic committee：

025-52276505

Contact email of the ethic committee：

njszyyll@163.com

Primary sponsor：

Nanjing Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Traditional Chinese Medicine (Nanjing Hospital of Traditional Chinese Medicine)

Primary sponsor's address：

Nanjing Hospital of Traditional Chinese Medicine Daming Road Qinhuai District Nanjing Jiangsu Province China

Secondary sponsor：

Country：

China

Province：

Jiangsu Province

City：

Nanjing

Institution
hospital：

Nanjing Hospital of Traditional Chinese Medicine

Address：

Nanjing Hospital of Traditional Chinese Medicine No. 157 Daming Road Qinhuai District Nanjing Jiangsu Province China

Source(s) of funding：

self-finance

Target disease：

Postoperative trauma of anal fistula

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

The purpose of this study is mainly to evaluate the clinical efficacy of uropodophyllum compound gel on postoperative wounds of anal fistula patients in a prospective randomized controlled manner and to provide a basis for the clinical application of uropodophyllum compound gel.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(i) patients who met the diagnostic criteria for low simple anal fistula; Diagnostic criteria: (1) Symptoms: redness swelling heat and pain in the anus or pus overflow from the ulceration the condition is capricious and there may be systemic reaction in the acute stage. (2) Specialized examination: outside the anus can be seen ulcerated mouth or raised nodules; finger examination can be touched to the cord-like tube leading to the anus often can be touched at the inner mouth of the nodules; anoscopy can be seen at the inner mouth of the sinus sinus deep depression or mucous membrane congestion and sometimes squeezed to see the secretion from the sinus sinus overflow. (3) Classification criteria: there is only one fistula an internal and external opening and the internal opening is usually in the anal recess corresponding to the external opening and the fistula is located in the external sphincter deep below. (ii) aged between 18-65 years old regardless of gender; (iii) agreed to participate in the observation

Exclusion criteria：

① ulcerative colitis Crohn's tuberculosis or other unknown infections caused by specific anal fistula; ② previous history of anal fistula and other anal surgery; ③ combination of cardiovascular cerebrovascular hepatic renal hematologic and other serious diseases psychiatric patients; ④ pregnancy and lactation; ⑤ allergy or allergic to the composition of the preparation of the drug; ⑥ the use of other drugs may affect the results of the study; ⑦ be participating in multi-topic research and do not want to join the study; ⑧ do not meet the inclusion criteria to determine the efficacy or incomplete information that affects the efficacy or safety judgment.

Study execute time：

From 2023-11-01

To      2025-01-31

Recruiting time：

From 2023-11-01

To      2025-01-31

Interventions：

30

Group：

ointment group

Sample size：

Intervention：

Ampelopsis Ointment

Intervention code：

30

Group：

Rejuvenate Liquid group

Sample size：

Intervention：

Rejuvenate Liquid

Intervention code：

30

Group：

Compound Gel Group

Sample size：

Intervention：

Ampelopsis Compound Gel

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution/hospital：

Nanjing Hospital of Traditional Chinese Medicine

Level of the institution：

grade 3A

Outcomes：

Outcome：

serum fibronectin

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Healing time of the wound

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

pain index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

伤口愈合率

Type：

Primary indicator

Measure time point of outcome：

Postoperative days 2, 4, 7, and 14 at 8:00 a.m. are time-phase points

Measure method：

Wound healing rate = (original area of the wound on the day of surgery - area of the wound on the day of observation)/original area of the wound on the day of surgery×100%.

Outcome：

IL-6

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Wound secretion

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Growth of sarcomeres

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Inclusion of patients the use of SPSS 26.0 software for the enrolled patients in the district group random grouping method according to the order of enrollment numbered 1-90 and data imported into the SPSS 26.0 software set the start time of the study for the random number of seeds after each number corresponds to the generation of a random number the random number of the group of Yu in accordance with the size of the order according to the number of divided into three groups the three groups respectively expressed as the routine medication group ointment group and compound gel group the random number of Yu corresponding to the number of the group that corresponds to the number of patients should be included in the group. The three groups are respectively indicated as routine dressing change group ointment group and compound gel group and the group in which the number corresponding to the random number is located is the group in which the patient corresponding to the number should be enrolled. The trial was c

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Please contact the corresponding author by e-mail if you need the raw data after the experiment is completed and the paper is published.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

CRF

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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