the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

Completed

• Conditions: Healing of the Wound After Rectovaginal Fistula Surgery
• Interventions: Procedure: the mCP with alginates dressing; Procedure: only alginates dressing

• Registration Number: NCT05138965
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

The method of Cotton Padding (mCP) was summarized by combining with many years clinical experience and the traditional ancient books.The mCP could be used in Rectovaginal Fistula (RVF) post operation effectively,in order to improve the wound.The research aim is to observe if the mCP could influence the time of staying in hospital, healing time after RVF surgery.

Detailed Description

The method of Cotton Padding (mCP) originating from extensive and profound traditional chinese medicine (TCM) and being one of traditional surgical treatments of chronic wounds,could promote the wound healing after RVF surgery in previous clinical experience.

The research aim is to observe if the mCP could influence the time of staying in hospital, healing time,quality of life,complications after RVF surgery.

Also,investigators will try to explain the mechanism about the mDM improving the wound healing by the chinese architectural theory and the nanomechanical properties.

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-01
• Study Start: 2022-01-10
• Status Verified: 2024-03
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• rectovaginal fistula because of parturition,stapler,traumatic injury.

Exclusion Criteria

• rectovaginal fistula because of IBD,radiation,cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
using the mCP	the mCP with alginates dressing	When the secretion reducing or the wound suture being removed, two pieces of 5cm×7cm-12p sterile gauzes will be crimped by the long side as the center of the reel,and be made as cylindrical gauze rolls with about D=1.5cm. After cleaning the wound, the cylindrical gauze rolls with its surface covered by alginates dressing will be placed above the vaginal wound with the help of endoscope.Itself tension of the rolls pressuring on the wound and the deep tissue can promote the wound healing. The rolls will be placed on about 5-6 hours every time, 2 times a day, for 7 days.Then observing the wound, if necessary, the method will be executed for another 7 days.
no using the mCP	only alginates dressing	When the secretion reducing or the wound suture bing removed, only alginates dressing will be placed above the vaginal wound with the help of endoscope, without any pressure, being placed about 5-6 hours every time, 2 times a day, for 7 days.

Primary Outcome Measures

Name	Time	Method
the time of healing	28days-40days	the time of healing

Secondary Outcome Measures

Name	Time	Method
the time of staying hospital	7days-21days	the time of staying hospital
occurrence rate of complications	1day-90days	occurrence rate of complications,including recurrence,blooding,wound dehiscence.

Trial Locations

Locations (3)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China

Beijing Mayinglong Changqing Anorectal Hospital; 🇨🇳 Beijing, China

Southern District of Guang'an men Hospital,China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China