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Status unknownNCT04757623Updated Feb 17, 2021

COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"

An interventional study of Purse string closure of Ileostomy in Surgical Site Infection and Difference in Surgical Site Infection According to Gender and Age Groups, sponsored by Combined Military Hospital, Pakistan. Status unknown at 2 sites in Pakistan. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Combined Military Hospital, Pakistan · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The study will be carried out in Surgical Unit-III, Lahore General Hospital, Lahore for one year . . Patients undergoing surgery for Ileostomy will be randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay.

Read the detailed description

The study will be carried out in Surgical Unit-III, Lahore General Hospital. It will be a randomized control trial. Patients undergoing surgery for Ileostomy were randomly divided into two groups, Group-A (Purse-string closure) and Group-B (Conventional primary closure). All the patients will be called for follow-up checkup on 14th days after operation and after one month. Both of the groups will be checked and recorded for SSI after operation and hospital stay. The data will be statistically analyzed by using SPSS v23.0.t test (independent sample) used for the comparison of hospital stay mean. Chi-square will also used for the comparison of the frequencies of SSI. Data were stratified for gender and age. A p-value ≤0.05 will be considered as significant.

02

Conditions studied

  • Surgical Site Infection
  • Difference in Surgical Site Infection According to Gender and Age Groups
03

In context

Surgical Wound Infection

745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.

This study's planned enrollment of 140 is below the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Combined Military Hospital, Pakistan is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • included in the study 1. Patients of both gender 2. Patients ages between 25-70 3. Patients undergoing surgery for having ileostomy for benign disease of intestine (as per operational definitions).

Exclusion criteria

Exclusion Criteria:

  • Following patients were excluded 1. Patients with pre-existing stomal site wound infection 2. Reversal of stoma through laparatomy 3. Post-operative anastomotic leak 4. Ureamic patients 5. Patients on chemotherapy and radiations
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
140 participants (estimated)

Study arms

  • No intervention
    Group B : conventional primary closure

    allileostomies are reversed with conventional method

  • Experimental
    Group A: Purse string closure

    the ileostomy reversal circular incision used with stitches of continuous and non-absorbable. The wound of skin was closed by using (Proline No. 1) that leaving 0.5 cm defect on middle in the skin.

    Procedure: Purse string closure of Ileostomy

Interventions

  • ProcedurePurse string closure of Ileostomy

    conventional proceedure

06

What researchers measure

Primary outcomes

  1. Surgical Site infection

    surgical site infection was graded according to southampton score grade IV and V

    Time frame: 14th post operative day

07

Study locations

2 of 2 sites recruiting
  • Anum Arif
    Lahore, Select A State Or Province 0092, Pakistan
    Recruiting
  • Ammad Asim
    Karachi, 75050, Pakistan
    Recruiting
    • Ammad Asim · Contact03333052892
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2021; primary completion for Feb 2022, 12 months later.

Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.

Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2021
First posted
Feb 17, 2021
StartEst.
Feb 16, 2021
Primary completionEst.
Feb 16, 2022
CompletionEst.
Mar 16, 2022
Last update
Feb 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04757623
Lead sponsor
Combined Military Hospital, Pakistan
Responsible party
Dr Anum Arif (Anum Arif, Combined Military Hospital, Pakistan) — Principal investigator
First posted
Feb 17, 2021
Start date
Feb 16, 2021 (estimated)
Primary completion
Feb 16, 2022 (estimated)
Completion
Mar 16, 2022 (estimated)
Last update
Feb 17, 2021

Study contacts

Anum Arif, MBBS FCPS
Contact
dranumarif@yahoo.com
0342238424
Ammad Asim
Contact
ammadasim@gmail.com
03333052892

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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