NCT04785404

Brief Summary

to compare infection rate stoma reversal skin wound after primary or secondary closure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

March 2, 2021

Last Update Submit

July 5, 2021

Conditions

Wound Infection

Keywords

skin closurestoma reversal

Outcome Measures

Primary Outcomes (1)

  • surgical site infection

    skin wound infection at surgical site will be observed on CDC guidelines

    30 days

Study Arms (2)

primary skin closure

EXPERIMENTAL

in this group, skin wound will be primarily closed

Procedure: primary skin closure

secondary skin closure

NO INTERVENTION

skin will be left open to heal by secondary intention

Interventions

primary skin closurePROCEDURE

skin will be stitched after stoma reversal to heal by primary intention

primary skin closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who undergo ileostomy or colostomy reversal will be included

You may not qualify if:

  • included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayub teaching hospital

Abbottābād, Khyber Pakhtunkhwa, 22040, Pakistan

Location

Related Publications (1)

  • Akbar I, Javed Z, Batool N. Primary versus secondary closure of stoma reversal skin wound: Randomized controlled trial. J Pak Med Assoc. 2023 Jan;73(1):4-8. doi: 10.47391/JPMA.3771.

    PMID: 36841997DERIVED

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Zanib Javed, FCPS

    Ayub Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients will be randomly distributed to two groups. Group A patients will have skin wounds stithed after stoma reversal while in secondary closure group B, wound will be allowed to heal by secondary intention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

will be shared after publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after publication
Access Criteria
request will be reviewed by the investigators and and further decision regarding access will be made.after publication in indexed journal it will be available online

Locations

PA(1)