Primary Versus Secondary Closure of Stoma-Reversal Skin Wound

Sponsor

Ayub Teaching Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04785404

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Wound Infection	Procedure: primary skin closure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 intentionpatients 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Primary Versus Secondary Closure of Stoma-Reversal Skin Wound: Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: primary skin closure in this group, skin wound will be primarily closed	Procedure: primary skin closure skin will be stitched after stoma reversal to heal by primary intention
No Intervention: secondary skin closure skin will be left open to heal by secondary intention

Arm

Intervention/Treatment

Experimental: primary skin closure

in this group, skin wound will be primarily closed

Procedure: primary skin closure

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

No Intervention: secondary skin closure

skin will be left open to heal by secondary intention

Outcome Measures

Primary Outcome Measures

surgical site infection [30 days]
skin wound infection at surgical site will be observed on CDC guidelines

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayub teaching hospital	Abbottābād	Khyber Pakhtunkhwa	Pakistan	22040

Sponsors and Collaborators

Ayub Teaching Hospital

Investigators

Principal Investigator: Zanib Javed, FCPS, Ayub Teaching Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayub Teaching Hospital

ClinicalTrials.gov Identifier:

NCT04785404

Other Study ID Numbers:

AyubTH

First Posted:

Mar 5, 2021

Last Update Posted:

Jul 8, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayub Teaching Hospital

skin closure

stoma reversal

Additional relevant MeSH terms:

Wound Infection

Wounds and Injuries

Study Results

No Results Posted as of Jul 8, 2021