NCT03537313

Brief Summary

Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 22, 2020

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

May 11, 2018

Last Update Submit

October 20, 2020

Conditions

Febrile Morbidity

Outcome Measures

Primary Outcomes (1)

  • Febrile morbidity

    Defined as the presence of an oral temperature \> 38 o C (100.4 o F) on two occasions at least 4 hours apart in the post-operative period excluding the first 24 hours

    Day 1-7 after surgery

Secondary Outcomes (2)

  • Vaginal cuff infection

    2 weeks after surgery

  • Other infectious morbidities

    2 weeks after surgery

Study Arms (4)

Control-douching group

NO INTERVENTION

No preoperative vagina douching

Control-painting group

NO INTERVENTION

No intra-operative vagina painting

Vaginal douching group

EXPERIMENTAL

Preoperative vaginal douches with povidone-iodine solution

Procedure: Vagina douching

Vaginal painting group

EXPERIMENTAL

Intra-operative vaginal painting with povidone-iodine solution

Procedure: Vagina painting

Interventions

Vagina douchingPROCEDURE

Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery

Vaginal douching group
Vagina paintingPROCEDURE

Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml

Vaginal painting group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who undergoing total abdominal hysterectomy
  • Woman who agrees to participate in this study

You may not qualify if:

  • Women with history of sea-food or iodine allergy
  • Women who undergo emergency TAH
  • Women who have intestinal resection in this operation
  • Women who have active pelvic inflammatory disease before operation
  • Women who have fever before operation
  • Women who received antibiotic within 1 weeks before operation
  • Women who be immunocompromised host

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Factorial 2-by-2 open labeled randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 25, 2018

Study Start

August 15, 2018

Primary Completion

September 15, 2018

Study Completion

September 30, 2018

Last Updated

October 22, 2020

Record last verified: 2018-05

Locations

TH(1)