Wound InfectionNCT04785404
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound
A study testing primary skin closure in people with Wound Infection, run by Ayub Teaching Hospital at 1 site in Pakistan.
Trial summary
to compare infection rate stoma reversal skin wound after primary or secondary closure Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Infection
- What is being tested?
- primary skin closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- . All patients who undergo ileostomy or colostomy reversal will be included
Who cannot join
- included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Wound Infection
- Being tested
- primary skin closure
- Keywords
- skin closure, stoma reversal
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary skin closureProcedure or surgery
skin will be stitched after stoma reversal to heal by primary intention
| Study group | Role | What they receive |
|---|---|---|
| primary skin closure | Experimental | in this group, skin wound will be primarily closed Receives: Procedure: primary skin closure |
| secondary skin closure | No intervention | skin will be left open to heal by secondary intention |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
skin wound infection at surgical site will be observed on CDC guidelines
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 intention
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayub Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zanib Javed, FCPS, Principal investigator, Ayub Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785404
- Sponsor's protocol ID
- AyubTH
- Status last verified
- Jul 2021
- First submitted
- 2 Mar 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be shared after publication
Publications
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.
PubMed 36841997
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Versus Secondary Closure of Stoma-Reversal Skin Wound: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04785404
- Acronym / sponsor ID
- AyubTH
- Conditions
- Wound Infection
- Keywords
- skin closure, stoma reversal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ayub Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Mar 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.
to compare infection rate stoma reversal skin wound after primary or secondary 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 intention
| Arm | Type | Receives |
|---|---|---|
| primary skin closure | Experimental | Procedure: primary skin closurein this group, skin wound will be primarily closed |
| secondary skin closure | No intervention | –skin will be left open to heal by secondary intention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- . All patients who undergo ileostomy or colostomy reversal will be included
Key exclusion criteria (1 listed)
- included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc
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 |
|---|---|---|
| primary skin closureskin will be stitched after stoma reversal to heal by primary intention | Procedure or surgery | primary skin closure |
Primary outcome
surgical site infection
Time frame: 30 days
skin wound infection at surgical site will be observed on CDC guidelines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Derived from this study: PubMed 36841997Akbar 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.
- Individual participant dataSharing planned: Yes. will be shared after publication
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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.
Zanib Javed, FCPS principal investigator
Ayub Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary skin closure in people with Wound Infection, run by Ayub Teaching Hospital at 1 site 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: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04785404, which also lists 1 linked publication.
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 8 Jul 2021.