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Clinical Trials/CTRI/2023/04/051644
CTRI/2023/04/051644Not yet recruitingPhase 1/2

A Clinical Study To Compare The Efficacy Of Epiheal- Episiotomy Wound Healing Spray With Betadine Ointment In The Management Of Episiotomy Wound Healing

iHub Gujarat M2M Mind to Market1 site in 1 country42 target enrollmentStarted: April 20, 2023Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Wound healing and antiseptic action

Study Overview

Brief Summary

Episiotomy is a surgical planned incision on the perineum and posterior vaginal wall during the second stage of labour. It’s also known as perineotomy.It is an inflicted second degree perineal injury.It is the commonest obstetrical operation performed. If proper care is not taken, then chances of it getting infected is high. With infection, dehiscence is a concern.

As perineal region is highly susceptible to infections due to the proximity of both excretory orifices and vaginal discharges. It is therefore  necessary to take proper care of the wound. Episiotomy wound can be compared to chhinnavrana (a kind of sadhyovrana). The treatment of sadhyovrana is therefore indicated. Aalepa is one among shashtiupakurma which has been incorporated in our classics for better wound healing with minimum scar formation.

Epiheal spray is a polyherbal spray which will be sprayed over the wound to adhere over it while the drugs act on the wound.

Thus in the present study the efficacy of Epiheal- Episiotomy wound healing Spray will be observed under aseptic precautions and results will be tabulated in the dissertation.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Parturient women of either primiparous or multiparous, irrespective of the type of suturing, who had full term normal delivery with episiotomy will be selected.
  • Patients between age 20-35 years will be selected Those patients who will be ready to sign the informed consent form will be included.

Exclusion Criteria

  • Patient with H/O PIH Patient with perineal tear and injury to external genitalia.
  • Instrumental delivery High risk Pregnancy Perineal skin infection • Diabetes Mellitus • Anaemia (Hb less than 8g/dl).

Outcomes

Primary Outcomes

Wound healing and antiseptic action

Time Frame: Assessment will be done on Day0, Day 7 and Day 14(without medicine)

Secondary Outcomes

  • Pain relief(Assessment will be done on Daily)

Investigators

Sponsor
iHub Gujarat M2M Mind to Market
Sponsor Class
Government funding agency

Study Sites (1)

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