Surgical Site Infection (SSI)NCT07573423
Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal.
A study testing Linear Skin Closure and Purse-String Skin Closure in people with Surgical Site Infection (SSI) and Ileostomy Closure, run by Hayat Abad Medical Complex, Peshawar at 1 site in Pakistan.
Trial summary
This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Surgical Site Infection (SSI), Ileostomy Closure, Surgical Technique Comparison
- What is being tested?
- Linear Skin Closure and Purse-String Skin Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jun 2020to 31 Jul 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 70 years
- Both male and female patients
- Patients undergoing elective loop ileostomy reversal
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients who provide informed consent
Who cannot join
- Patients with active stoma site infection (e.g., fever with total leukocyte count >11,000/mm³)
- Patients not planned for ileostomy reversal
- Patients with severe comorbid conditions (ASA III or above)
- Patients unwilling to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy Between Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal. A Randomized Control Trial.
This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Surgical site infection (SSI) is one of the most frequent complications following stoma closure, leading to increased patient discomfort, prolonged hospital stay, and higher healthcare costs.
In this trial, eligible adult patients undergoing elective loop ileostomy reversal are randomly assigned to either linear skin closure or purse-string skin closure. The purse-string technique leaves a small central opening that allows drainage, which may reduce infection risk, whereas linear closure involves complete approximation of the wound edges.
Read more
All patients are managed according to standard hospital protocols and are followed during their hospital stay and for 30 days after surgery. The primary outcome is the occurrence of surgical site infection. Secondary outcomes include length of hospital stay and operative time.
The purpose of this study is to determine which closure technique provides better outcomes in terms of reducing postoperative infections and improving recovery. The findings may help guide surgeons in selecting the most effective and safe method for skin closure after ileostomy reversal.
Read the detailed description
Loop ileostomy reversal is a commonly performed surgical procedure; however, it is associated with a considerable risk of postoperative complications, particularly surgical site infection (SSI). Reported SSI rates after stoma closure range from 4% to over 20%, making it one of the most frequent causes of postoperative morbidity. The development of SSI not only delays wound healing but also contributes to prolonged hospital stay, increased healthcare costs, and reduced patient satisfaction.
Multiple techniques for skin closure following ileostomy reversal have been described, with conventional linear closure and purse-string closure being the most widely practiced. Linear closure involves primary approximation of the wound edges, resulting in complete closure of the skin. In contrast, the purse-string technique leaves a small central opening that allows continuous drainage of wound exudate, which may reduce bacterial colonization and lower the risk of infection.
Previous studies have suggested that purse-string closure may be associated with lower SSI rates and improved cosmetic outcomes compared to linear closure. However, linear closure remains widely used due to its technical simplicity and shorter operative time. Despite available evidence, there is still variability in clinical practice, and further high-quality randomized controlled trials are needed to establish the optimal technique.
This randomized controlled trial was conducted at the Department of General Surgery, MTI-Hayatabad Medical Complex, Peshawar. A total of 252 patients meeting the inclusion criteria were enrolled and randomly allocated into two groups: linear skin closure (Group A) and purse-string skin closure (Group B). Block randomization was used to ensure balanced group allocation.
All patients underwent ileostomy reversal according to standardized surgical protocols. Preoperative optimization, including management of comorbid conditions such as diabetes mellitus and hypertension, was performed as per institutional guidelines. Postoperatively, patients were monitored during their hospital stay and followed up for 30 days to assess outcomes.
The primary outcome of the study was the frequency of surgical site infection within 30 days of surgery. Secondary outcomes included length of hospital stay and duration of surgery. Data were collected using a structured proforma and analyzed using appropriate statistical methods.
The aim of this study is to provide evidence on the comparative effectiveness of purse-string versus linear skin closure techniques in reducing postoperative complications following ileostomy reversal. The results are expected to support evidence-based surgical practice and improve patient outcomes.
- Being tested
- Linear Skin Closure, Purse-String Skin Closure
- Keywords
- Surgical Site Infections, Purse-string skin closure, Linear skin closure, Wound closure techniques, Postoperative complications, Randomized controlled trial
- Medical subject headings
- Surgical Wound Infection, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Skin ClosureProcedure or surgery
Closure of the ileostomy reversal wound using conventional linear suturing with complete approximation of skin edges.
Purse-String Skin ClosureProcedure or surgery
Closure of the ileostomy reversal wound using purse-string suturing technique, leaving a central gap for drainage to reduce infection risk.
| Study group | Role | What they receive |
|---|---|---|
| Linear Skin Closure | Active comparator | Participants undergoing loop ileostomy reversal receive conventional linear skin closure with primary approximation of wound edges. Receives: Procedure: Purse-String Skin Closure |
| Purse-String Skin Closure | Active comparator | Participants undergoing loop ileostomy reversal receive purse-string skin closure, leaving a small central opening to allow drainage. Receives: Procedure: Linear Skin Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infections Rate
Proportion of participants who develop surgical site infection at the ileostomy reversal wound site, assessed using standard clinical criteria (redness, discharge, swelling, or pus).
Measured: Within 30 days after surgery
Secondary outcomes (1)
Length of Hospital Stay
Duration of hospital stay measured in days from the date of surgery to discharge.
Measured: From surgery until hospital discharge (up to 7 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start22 Jun 2020
- Primary completion1 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection (SSI)Studies 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
- Participants are randomly assigned in a 1:1 ratio to either linear skin closure (Group A) or purse-string skin closure (Group B) following loop ileostomy reversal. Both groups are followed prospectively to compare postoperative outcomes.
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayat Abad Medical Complex, Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gohar Ali, Hayat Abad Medical Complex, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573423
- Sponsor's protocol ID
- HMC-QAD-RCT-3
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ameer A, Mirza MB, Talat N. The Outcome of Purse-string Versus Conventional Wound Closure Techniques in Patients Undergoing Stoma Reversal: A Randomized Controlled Trial. J Pediatr Surg. 2024 Jun;59(6):1186-1189. doi: 10.1016/j.jpedsurg.2023.10.062. Epub 2023 Oct 30.
PubMed 37978002O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.
PubMed 29149428Aga E, Keinan-Boker L, Eithan A, Mais T, Rabinovich A, Nassar F. Surgical site infections after abdominal surgery: incidence and risk factors. A prospective cohort study. Infect Dis (Lond). 2015;47(11):761-7. doi: 10.3109/23744235.2015.1055587. Epub 2015 Jun 26.
PubMed 26114986Nota SP, Braun Y, Ring D, Schwab JH. Incidence of surgical site infection after spine surgery: what is the impact of the definition of infection? Clin Orthop Relat Res. 2015 May;473(5):1612-9. doi: 10.1007/s11999-014-3933-y.
PubMed 25212963
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Between Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07573423
- Acronym / sponsor ID
- HMC-QAD-RCT-3
- Keywords
- Surgical Site Infections, Purse-string skin closure, Linear skin closure, Wound closure techniques, Postoperative complications, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Hayat Abad Medical Complex, PeshawarOther government
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 7 May 2026 (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.
This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Surgical site infection (SSI) is one of the most frequent complications following stoma closure, leading to increased patient discomfort, prolonged hospital stay, and higher healthcare costs.
In this trial, eligible adult patients undergoing elective loop ileostomy reversal are randomly assigned to either linear skin closure or purse-string skin closure. The purse-string technique leaves a small central opening that allows drainage, which may reduce infection risk, whereas linear closure involves complete approximation of the wound edges.
All patients are managed according to standard hospital protocols and are followed during their hospital stay and for 30 days after surgery. The primary outcome is the occurrence of surgical site infection. Secondary outcomes include length of hospital stay and operative time.
The purpose of this study is to determine which closure technique provides better outcomes in terms of reducing postoperative infections and improving recovery. The findings may help guide surgeons in selecting the most effective and safe method for skin closure after ileostomy reversal.
Detailed description
Loop ileostomy reversal is a commonly performed surgical procedure; however, it is associated with a considerable risk of postoperative complications, particularly surgical site infection (SSI). Reported SSI rates after stoma closure range from 4% to over 20%, making it one of the most frequent causes of postoperative morbidity. The development of SSI not only delays wound healing but also contributes to prolonged hospital stay, increased healthcare costs, and reduced patient satisfaction.
Multiple techniques for skin closure following ileostomy reversal have been described, with conventional linear closure and purse-string closure being the most widely practiced. Linear closure involves primary approximation of the wound edges, resulting in complete closure of the skin. In contrast, the purse-string technique leaves a small central opening that allows continuous drainage of wound exudate, which may reduce bacterial colonization and lower the risk of infection.
Previous studies have suggested that purse-string closure may be associated with lower SSI rates and improved cosmetic outcomes compared to linear closure. However, linear closure remains widely used due to its technical simplicity and shorter operative time. Despite available evidence, there is still variability in clinical practice, and further high-quality randomized controlled trials are needed to establish the optimal technique.
This randomized controlled trial was conducted at the Department of General Surgery, MTI-Hayatabad Medical Complex, Peshawar. A total of 252 patients meeting the inclusion criteria were enrolled and randomly allocated into two groups: linear skin closure (Group A) and purse-string skin closure (Group B). Block randomization was used to ensure balanced group allocation.
All patients underwent ileostomy reversal according to standardized surgical protocols. Preoperative optimization, including management of comorbid conditions such as diabetes mellitus and hypertension, was performed as per institutional guidelines. Postoperatively, patients were monitored during their hospital stay and followed up for 30 days to assess outcomes.
The primary outcome of the study was the frequency of surgical site infection within 30 days of surgery. Secondary outcomes included length of hospital stay and duration of surgery. Data were collected using a structured proforma and analyzed using appropriate statistical methods.
The aim of this study is to provide evidence on the comparative effectiveness of purse-string versus linear skin closure techniques in reducing postoperative complications following ileostomy reversal. The results are expected to support evidence-based surgical practice and improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either linear skin closure (Group A) or purse-string skin closure (Group B) following loop ileostomy reversal. Both groups are followed prospectively to compare postoperative outcomes.
| Arm | Type | Receives |
|---|---|---|
| Linear Skin Closure | Active comparator | Procedure: Purse-String Skin ClosureParticipants undergoing loop ileostomy reversal receive conventional linear skin closure with primary approximation of wound edges. |
| Purse-String Skin Closure | Active comparator | Procedure: Linear Skin ClosureParticipants undergoing loop ileostomy reversal receive purse-string skin closure, leaving a small central opening to allow drainage. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 to 70 years
- Both male and female patients
- Patients undergoing elective loop ileostomy reversal
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients who provide informed consent
Key exclusion criteria (4 listed)
- Patients with active stoma site infection (e.g., fever with total leukocyte count >11,000/mm³)
- Patients not planned for ileostomy reversal
- Patients with severe comorbid conditions (ASA III or above)
- Patients unwilling to participate in the study
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 |
|---|---|---|
| Linear Skin ClosureClosure of the ileostomy reversal wound using conventional linear suturing with complete approximation of skin edges. | Procedure or surgery | Purse-String Skin Closure |
| Purse-String Skin ClosureClosure of the ileostomy reversal wound using purse-string suturing technique, leaving a central gap for drainage to reduce infection risk. | Procedure or surgery | Linear Skin Closure |
Primary outcome
Surgical Site Infections Rate
Time frame: Within 30 days after surgery
Proportion of participants who develop surgical site infection at the ileostomy reversal wound site, assessed using standard clinical criteria (redness, discharge, swelling, or pus).
1 secondary outcome
Length of Hospital Stay
Time frame: From surgery until hospital discharge (up to 7 days after surgery)
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 12 May 2026.
- Results publication: PubMed 37978002Ameer A, Mirza MB, Talat N. The Outcome of Purse-string Versus Conventional Wound Closure Techniques in Patients Undergoing Stoma Reversal: A Randomized Controlled Trial. J Pediatr Surg. 2024 Jun;59(6):1186-1189. doi: 10.1016/j.jpedsurg.2023.10.062. Epub 2023 Oct 30.
- Results publication: PubMed 29149428O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.
- Results publication: PubMed 26114986Aga E, Keinan-Boker L, Eithan A, Mais T, Rabinovich A, Nassar F. Surgical site infections after abdominal surgery: incidence and risk factors. A prospective cohort study. Infect Dis (Lond). 2015;47(11):761-7. doi: 10.3109/23744235.2015.1055587. Epub 2015 Jun 26.
- Results publication: PubMed 25212963Nota SP, Braun Y, Ring D, Schwab JH. Incidence of surgical site infection after spine surgery: what is the impact of the definition of infection? Clin Orthop Relat Res. 2015 May;473(5):1612-9. doi: 10.1007/s11999-014-3933-y.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Skin Closure and Purse-String Skin Closure in people with Surgical Site Infection (SSI) and Ileostomy Closure, run by Hayat Abad Medical Complex, Peshawar 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 5 inclusion and 4 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 12 May 2026. 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 Infections Rate (time frame: Within 30 days after surgery). 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 NCT07573423, which also lists 4 linked publications.
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 12 May 2026.