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the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05138965
Enrollment
20
Registered
2021-12-01
Start date
2022-01-10
Completion date
2024-03-15
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing of the Wound After Rectovaginal Fistula Surgery

Keywords

Rectovaginal Fistula, Healing, Cotton Padding

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.

Interventions

PROCEDUREthe mCP with alginates dressing

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.

PROCEDUREonly alginates dressing

Only alginates dressing will be placed above the RVF wound without any pressure.

Sponsors

China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* rectovaginal fistula because of IBD,radiation,cancer.

Design outcomes

Primary

MeasureTime frameDescription
the time of healing28days-40daysthe time of healing

Secondary

MeasureTime frameDescription
the time of staying hospital7days-21daysthe time of staying hospital
occurrence rate of complications1day-90daysoccurrence rate of complications,including recurrence,blooding,wound dehiscence.

Other

MeasureTime frameDescription
the quality of life post-operation90days-180daysusing the Wexner continence score (WCS) or the Vaizey score (VS) to assess the fecal incontinence,and using the Female sexual function index (FSFI) to assess the sex life,and aslo using the Clavien-Dindo classification(CDC) to assess other situation postoperatively.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026