Primary Versus Secondary Closure of Stoma-Reversal Skin Wound

NCT ID: NCT04785404

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

primary skin closure

in this group, skin wound will be primarily closed

Group Type EXPERIMENTAL

primary skin closure

Intervention Type PROCEDURE

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

secondary skin closure

skin will be left open to heal by secondary intention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

primary skin closure

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ayub Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zanib Javed, FCPS

Role: PRINCIPAL_INVESTIGATOR

Ayub Teaching Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ayub teaching hospital

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36841997 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AyubTH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Small Bites Vs Large Bites Abdominal Midline Incisional Closure
NCT07154277 ACTIVE_NOT_RECRUITING PHASE2/PHASE3