the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

Study Overview
=================
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.

Official Title
-----------------
Research About the Method of Cotton Padding Promoting the Healing of the Wound After Rectovaginal Fistula Surgery

Conditions
-----------------
Healing of the Wound After Rectovaginal Fistula Surgery

Intervention / Treatment
-----------------
* Procedure: the mCP with alginates dressing
* Procedure: only alginates dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectovaginal fistula because of parturition,stapler,traumatic injury. Exclusion Criteria: rectovaginal fistula because of IBD,radiation,cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| using the mCP<br>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. | Procedure: the mCP with alginates dressing<br>* The method is to use gauzes folded onto the RVF wound surface to compact the deep wound so as to solid and durable,when the gauzes surface will be covered by alginates dressing.<br>* Other names: the method of cotton padding with alginates dressing;|
| no using the mCP<br>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. | Procedure: only alginates dressing<br>* Only alginates dressing will be placed above the RVF wound without any pressure.<br>* Other names: only alginates dressing without the mCP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of healing | the time of healing | 28days-40days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of staying hospital | the time of staying hospital | 7days-21days | 
| occurrence rate of complications | occurrence rate of complications,including recurrence,blooding,wound dehiscence. | 1day-90days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectovaginal Fistula, Healing, Cotton Padding