Surgical Site InfectionNCT04757623
COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
A study testing Purse string closure of Ileostomy in people with Surgical Site Infection and Difference in Surgical Site Infection According to Gender and Age Groups, run by Combined Military Hospital, Pakistan at 2 sites in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups
- What is being tested?
- Purse string closure of Ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesPakistan
- Study dates
- 16 Feb 2021to 16 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Ammad Asim
Karachi, 75050
Ammad Asim, 03333052892
- Recruiting
Anum Arif
Lahore, Select A State Or Province, 0092
Anum Arif, +923422398424, dranumarif@yahoo.com
About this study
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.
- Conditions
- Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups
- Being tested
- Purse string closure of Ileostomy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse string closure of IleostomyProcedure or surgery
conventional proceedure
| Study group | Role | What they receive |
|---|---|---|
| Group B : conventional primary closure | No intervention | allileostomies are reversed with conventional method |
| Group A: Purse string closure | Experimental | 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. Receives: Procedure: Purse string closure of Ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site infection
surgical site infection was graded according to southampton score grade IV and V
Measured: 14th post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start16 Feb 2021 (estimated)
- Primary completion16 Feb 2022 (estimated)
- Study completion16 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial of two arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anum Arif, Combined Military Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757623
- Sponsor's protocol ID
- LahoreGeneralHospital
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF PURSE-STRING CLOSURE VERSUS CONVENTIONAL PRIMARY CLOSURE FOLLOWING STOMA REVERSAL TO REDUCE SURGICAL SITE INFECTION RATE"
- ClinicalTrials.gov ID
- NCT04757623
- Acronym / sponsor ID
- LahoreGeneralHospital
- Conditions
- Surgical Site Infection, Difference in Surgical Site Infection According to Gender and Age Groups
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 16 Feb 2021 (estimated)
- Primary completion
- 16 Feb 2022 (estimated)
- Study completion
- 16 Mar 2022 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised control trial of two arms
| Arm | Type | Receives |
|---|---|---|
| Group B : conventional primary closure | No intervention | –allileostomies are reversed with conventional method |
| Group A: Purse string closure | Experimental | Procedure: Purse string closure of Ileostomythe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purse string closure of Ileostomyconventional proceedure | Procedure or surgery | Group A: Purse string closure |
Primary outcome
Surgical Site infection
Time frame: 14th post operative day
surgical site infection was graded according to southampton score grade IV and V
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purse string closure of Ileostomy in people with Surgical Site Infection and Difference in Surgical Site Infection According to Gender and Age Groups, run by Combined Military Hospital, Pakistan at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anum Arif, MBBS FCPS (0342238424, dranumarif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site infection (time frame: 14th post operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.