Primary Versus Secondary Closure of Stoma-Reversal Skin Wound

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

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

Study Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Procedure: primary skin 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Abbottābād, Khyber Pakhtunkhwa, Pakistan, 22040
      • Ayub Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ayub Teaching Hospital
• Investigators: Principal Investigator: Zanib Javed, FCPS, Ayub Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: skin closure; stoma reversal
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: AyubTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: will be shared after publication
• IPD Sharing Time Frame: after publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No