Primary Versus Secondary Closure of Stoma-Reversal Skin W... | NCT04785404

Studies
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound

NCT04785404

Sponsor

Ayub Teaching Hospital

Status

Completed

Last Update Posted

Jul 8, 2021Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Wound Infection

Interventions

primary skin closure

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Mar 2, 2021

First Submission Date that Met QC Criteria

Mar 4, 2021

First Posted Date

Mar 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2021

Last Update Posted Date

Jul 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

There will be two groups. In group A, skin will be stitched with prolene while in group B skin will be left open to follow up till 1 month and wound observed for infection according to CDC guidelines.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
primary skin closure	Procedure	skin will be stitched after stoma reversal to heal by primary intention	primary skin closure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical site infection	skin wound infection at surgical site will be observed on CDC guidelines	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zanib Javed, FCPS	Ayub Teaching Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ayub teaching hospital		Abbottābād	Khyber Pakhtunkhwa	22040	Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36841997	Derived	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.