Purse-String SutureNCT07335835
Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal
A study testing Purse-string skin closure and Conventional linear skin closure in people with Purse-String Suture and Wound Closure Technique, run by Assiut University.
Trial summary
This randomized controlled trial compares purse-string versus conventional linear skin closure techniques in children undergoing stoma reversal surgery. The primary aim is to assess surgical site infection rates within 30 days and scar cosmesis at 3 months using the Manchester Scar Scale. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Purse-String Suture, Wound Closure Technique, Conventional Wound Closure
- What is being tested?
- Purse-string skin closure and Conventional linear skin closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 1 month to 18 years undergoing stoma reversal after informed consent obtained from parents.
Who cannot join
- Patients with divided stomas .
- Patients who will lost to follow-up.
- Patients who will develop anastomotic leakage, organ/space SSI.
About this study
Official title: The Outcomes of Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal : Ramdomized Controlled Trial(RCT).
This randomized controlled trial compares purse-string versus conventional linear skin closure techniques in children undergoing stoma reversal surgery. The primary aim is to assess surgical site infection rates within 30 days and scar cosmesis at 3 months using the Manchester Scar Scale. Fifty patients (25 per group) will be randomized at Assiut University Pediatric Surgery Department to determine if purse-string closure reduces infections and improves scarring.
Read the detailed description
Stoma reversal surgery is commonly performed in pediatric patients, but complications including surgical site infection (SSI), poor scarring, anastomotic leak, paralytic ileus, adhesive intestinal obstruction, bleeding, and incisional hernia remain concerns. The frequency of SSI and scar formation is directly related to the wound closure technique employed.
Skin wounds in stoma reversal are typically closed using conventional linear closure technique; however, this method carries a higher risk of surgical site infections. Studies in adults have demonstrated that purse-string wound closure technique achieves better cosmetic outcomes and reduced risk of SSI compared to conventional linear closure. However, high-quality data comparing these techniques in pediatric populations undergoing stoma reversal is lacking.
This randomized controlled trial will enroll 50 pediatric patients (aged 1 month to 18 years) undergoing stoma reversal at the Pediatric Surgery Department, Assiut University Hospitals. Participants will be randomized using a lottery method in a 1:1 ratio to receive either conventional linear closure (Group A) using simple interrupted Prolene sutures or purse-string closure (Group B) using Vicryl for subcutaneous layers and Prolene for skin in a purse-string technique.
All patients will undergo standard stoma reversal procedures and receive postoperative care per departmental protocols. Wounds will be evaluated after the first dressing change, at hospital discharge, during stitch removal, and at follow-up visits continuing for 3-4 months. Surgical site infection will be assessed using CDC criteria. Scar cosmesis will be evaluated at a minimum of 3 months post-surgery using the Manchester scar scale by three independent assessors.
The study aims to compare the frequency of surgical site infections and cosmetic outcomes between the two closure techniques, providing evidence-based guidance for optimal wound closure in pediatric stoma reversal.
- Conditions
- Purse-String Suture, Wound Closure Technique, Conventional Wound Closure, Stoma Reversal Procedure, Pediatric Surgery
- Being tested
- Purse-string skin closure, Conventional linear skin closure
- Keywords
- Purse-String Suture, Wound Closure Technique, Conventional Wound Closure, Stoma Reversal, Pediatric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse-string skin closureProcedure or surgery
During stoma reversal, internal layers closed standardly; subcutaneous tissue closed with continuous Vicryl purse-string suture, skin with Prolene purse-string suture. Distinguishes from linear closure by circular tightening technique to reduce SSI risk and improve cosmesis in pediatric patients.
Conventional linear skin closureProcedure or surgery
During stoma reversal, skin wound closed with simple interrupted 3-0 Prolene sutures after standard internal and subcutaneous closure. Serves as active comparator to purse-string method; standard technique associated with higher SSI rates.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Linear Closure Arm | Experimental | Patients undergo stoma reversal surgery with skin wound closed using conventional linear technique: simple interrupted Prolene sutures after standard internal layer closure. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up. Receives: Procedure: Conventional linear skin closure |
| Purse-String Closure Arm | Active comparator | Patients undergo stoma reversal surgery with skin wound closed using purse-string technique: internal layers closed standardly, subcutaneous layer with Vicryl purse-string, skin with Prolene purse-string. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up. Receives: Procedure: Purse-string skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI)
Occurrence of SSI at stoma reversal site, defined per CDC criteria (purulent drainage, positive culture, or signs/symptoms of infection treated with antibiotics), assessed by surgeon at dressing changes, discharge, stitch removal, and patient-reported symptoms.
Measured: Up to 30 days post-surgery
Secondary outcomes (1)
Scar Cosmesis by Manchester Scar Scale
Scar assessed using Manchester Scar Scale (vascularity, pigmentation, contour, texture; score 0-24, lower better) by average of three independent blinded assessors.
Measured: Minimum 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purse-String SutureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Ali Abdallah Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335835
- Sponsor's protocol ID
- wound closure in children
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes of Purse String Versus Conventional Wound Closure Techniques in Children Undergoing Stoma Reversal : Ramdomized Controlled Trial(RCT).
- ClinicalTrials.gov ID
- NCT07335835
- Acronym / sponsor ID
- wound closure in children
- Conditions
- Purse-String Suture, Wound Closure Technique, Conventional Wound Closure, Stoma Reversal Procedure, Pediatric Surgery
- Keywords
- Purse-String Suture, Wound Closure Technique, Conventional Wound Closure, Stoma Reversal, Pediatric surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Jan 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 randomized controlled trial compares purse-string versus conventional linear skin closure techniques in children undergoing stoma reversal surgery. The primary aim is to assess surgical site infection rates within 30 days and scar cosmesis at 3 months using the Manchester Scar Scale. Fifty patients (25 per group) will be randomized at Assiut University Pediatric Surgery Department to determine if purse-string closure reduces infections and improves scarring.
Detailed description
Stoma reversal surgery is commonly performed in pediatric patients, but complications including surgical site infection (SSI), poor scarring, anastomotic leak, paralytic ileus, adhesive intestinal obstruction, bleeding, and incisional hernia remain concerns. The frequency of SSI and scar formation is directly related to the wound closure technique employed.
Skin wounds in stoma reversal are typically closed using conventional linear closure technique; however, this method carries a higher risk of surgical site infections. Studies in adults have demonstrated that purse-string wound closure technique achieves better cosmetic outcomes and reduced risk of SSI compared to conventional linear closure. However, high-quality data comparing these techniques in pediatric populations undergoing stoma reversal is lacking.
This randomized controlled trial will enroll 50 pediatric patients (aged 1 month to 18 years) undergoing stoma reversal at the Pediatric Surgery Department, Assiut University Hospitals. Participants will be randomized using a lottery method in a 1:1 ratio to receive either conventional linear closure (Group A) using simple interrupted Prolene sutures or purse-string closure (Group B) using Vicryl for subcutaneous layers and Prolene for skin in a purse-string technique.
All patients will undergo standard stoma reversal procedures and receive postoperative care per departmental protocols. Wounds will be evaluated after the first dressing change, at hospital discharge, during stitch removal, and at follow-up visits continuing for 3-4 months. Surgical site infection will be assessed using CDC criteria. Scar cosmesis will be evaluated at a minimum of 3 months post-surgery using the Manchester scar scale by three independent assessors.
The study aims to compare the frequency of surgical site infections and cosmetic outcomes between the two closure techniques, providing evidence-based guidance for optimal wound closure in pediatric stoma reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Linear Closure Arm | Experimental | Procedure: Conventional linear skin closurePatients undergo stoma reversal surgery with skin wound closed using conventional linear technique: simple interrupted Prolene sutures after standard internal layer closure. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up. |
| Purse-String Closure Arm | Active comparator | Procedure: Purse-string skin closurePatients undergo stoma reversal surgery with skin wound closed using purse-string technique: internal layers closed standardly, subcutaneous layer with Vicryl purse-string, skin with Prolene purse-string. Postoperative care follows departmental protocols, with wound assessments for SSI and scar evaluation at follow-up. |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children aged 1 month to 18 years undergoing stoma reversal after informed consent obtained from parents.
Key exclusion criteria (3 listed)
- Patients with divided stomas .
- Patients who will lost to follow-up.
- Patients who will develop anastomotic leakage, organ/space SSI.
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 skin closureDuring stoma reversal, internal layers closed standardly; subcutaneous tissue closed with continuous Vicryl purse-string suture, skin with Prolene purse-string suture. Distinguishes from linear closure by circular tightening technique to reduce SSI risk and improve cosmesis in pediatric patients. | Procedure or surgery | Purse-String Closure Arm |
| Conventional linear skin closureDuring stoma reversal, skin wound closed with simple interrupted 3-0 Prolene sutures after standard internal and subcutaneous closure. Serves as active comparator to purse-string method; standard technique associated with higher SSI rates. | Procedure or surgery | Conventional Linear Closure Arm |
Primary outcome
Surgical Site Infection (SSI)
Time frame: Up to 30 days post-surgery
Occurrence of SSI at stoma reversal site, defined per CDC criteria (purulent drainage, positive culture, or signs/symptoms of infection treated with antibiotics), assessed by surgeon at dressing changes, discharge, stitch removal, and patient-reported symptoms.
1 secondary outcome
Scar Cosmesis by Manchester Scar Scale
Time frame: Minimum 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Purse-string skin closure and Conventional linear skin closure in people with Purse-String Suture and Wound Closure Technique, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 (SSI) (time frame: Up to 30 days post-surgery). 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 13 Jan 2026.