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the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

C

China Academy of Chinese Medical Sciences

Status

Completed

Conditions

Healing of the Wound After Rectovaginal Fistula Surgery

Treatments

Procedure: only alginates dressing
Procedure: the mCP with alginates dressing

Study type

Observational

Funder types

Other

Identifiers

NCT05138965
2021-11-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • rectovaginal fistula because of IBD,radiation,cancer.

Trial design

20 participants in 2 patient groups

using the mCP
Description:
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.
Treatment:
Procedure: the mCP with alginates dressing
no using the mCP
Description:
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.
Treatment:
Procedure: only alginates dressing

Trial contacts and locations

3

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Central trial contact

FENG lipeng; LI guodong

Data sourced from clinicaltrials.gov

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