Surgical Site InfectionNCT07781878
Skin Staples vs Polypropylene in Elective Laparotomy
A study testing Skin staples and Polypropylene skin suture in people with Surgical Site Infection, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Surgical site infection (SSI) is one of the most common postoperative complications following elective laparotomy and contributes significantly to patient morbidity, prolonged hospital stay, and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Skin staples and Polypropylene skin suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Jan 2026to 31 Dec 2026
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 15-50 years Elective laparotomy ASA I-III Written informed consent Male or female
Who cannot join
- Emergency surgery Previous SSI Recurrent surgery BMI <18 or >30 kg/m² Haemoglobin <10 g/dL COPD Stroke Renal failure Liver disease Haematological disorders Malignancy Immunocompromised state Active infection Previous chemotherapy Previous radiotherapy Malnutrition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Institute of Medical Sciences
Islamabad, Capital
Fahad Ali, Mbbs, mrcs, 03320601136, joyafahad@gmail.com
About this study
Official title: Skin Staples Versus Polypropylene for Skin Closure in Elective Laparotomy: A Randomized Controlled Trial
Surgical site infection (SSI) is one of the most common postoperative complications following elective laparotomy and contributes significantly to patient morbidity, prolonged hospital stay, and increased healthcare costs. Various techniques are available for skin closure, including skin staples and polypropylene sutures; however, evidence regarding their comparative effectiveness remains inconsistent, particularly in low- and middle-income countries.
This randomized controlled trial aims to compare skin staples with polypropylene sutures for skin closure following elective laparotomy. Eligible adult patients undergoing elective laparotomy at the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), Islamabad, will be randomly allocated in a 1:1 ratio to receive either skin staples or polypropylene sutures.
Read more
The primary outcomes are skin closure time and incidence of surgical site infection within 30 days of surgery. Secondary outcomes include wound dehiscence, postoperative pain, cosmetic scar appearance, patient satisfaction, and duration of hospital stay.
The findings will provide evidence regarding the optimal skin closure technique for elective laparotomy in the Pakistani population.
- Conditions
- Surgical Site Infection
- Being tested
- Skin staples, Polypropylene skin suture
- Keywords
- Infection, SSI, SSIs, Laparatomy, Prolene suture, Staples, Wound Dehiscence, General surgery
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin staplesDevice
Disposable stainless steel skin staples will be used for skin closure following elective laparotomy. Skin closure will be performed according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), immediately after completion of fascial closure.
Polypropylene skin sutureDevice
Skin closure will be performed using interrupted polypropylene (Prolene) sutures following elective laparotomy according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS).
| Study group | Role | What they receive |
|---|---|---|
| Skin Staples | Experimental | Skin closure performed using disposable stainless steel skin staples. Receives: Device: Skin staples |
| Poly propylene sutures | Active comparator | Skin closure performed using interrupted polypropylene (Prolene) sutures. Receives: Device: Polypropylene skin suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
SSI occurring within 30 postoperative days based on CDC clinical criteria with wound culture where indicated.
Measured: 30 days
Secondary outcomes (4)
Skin closure time
Measured in seconds from the first skin puncture until completion of skin closure.
Measured: During the surgery
Wound Dehiscence
Giving way of the skin closure leading to exposure of subcutaneous tissues.
Measured: 30 days
Post-operative pain
Pain scored on verbal descriptor scale from 1 to 10
Measured: 7 days
Scar appearance
Visual description of scar on analogue scsle by subjective assessment(1-10)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start31 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Anam Nasim, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781878
- Sponsor's protocol ID
- F-5-2/2024(ERRC)PIMS
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2026
- Last updated
- 13 Oct 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Staples Versus Polypropylene for Skin Closure in Elective Laparotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07781878
- Acronym / sponsor ID
- F-5-2/2024(ERRC)PIMS
- Conditions
- Surgical Site Infection
- Keywords
- Infection, SSI, SSIs, Laparatomy, Prolene suture, Staples, Wound Dehiscence, General surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Aug 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.
Surgical site infection (SSI) is one of the most common postoperative complications following elective laparotomy and contributes significantly to patient morbidity, prolonged hospital stay, and increased healthcare costs. Various techniques are available for skin closure, including skin staples and polypropylene sutures; however, evidence regarding their comparative effectiveness remains inconsistent, particularly in low- and middle-income countries.
This randomized controlled trial aims to compare skin staples with polypropylene sutures for skin closure following elective laparotomy. Eligible adult patients undergoing elective laparotomy at the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), Islamabad, will be randomly allocated in a 1:1 ratio to receive either skin staples or polypropylene sutures.
The primary outcomes are skin closure time and incidence of surgical site infection within 30 days of surgery. Secondary outcomes include wound dehiscence, postoperative pain, cosmetic scar appearance, patient satisfaction, and duration of hospital stay.
The findings will provide evidence regarding the optimal skin closure technique for elective laparotomy in the Pakistani population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Staples | Experimental | Device: Skin staplesSkin closure performed using disposable stainless steel skin staples. |
| Poly propylene sutures | Active comparator | Device: Polypropylene skin sutureSkin closure performed using interrupted polypropylene (Prolene) sutures. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age 15-50 years Elective laparotomy ASA I-III Written informed consent Male or female
Key exclusion criteria (1 listed)
- Emergency surgery Previous SSI Recurrent surgery BMI <18 or >30 kg/m² Haemoglobin <10 g/dL COPD Stroke Renal failure Liver disease Haematological disorders Malignancy Immunocompromised state Active infection Previous chemotherapy Previous radiotherapy Malnutrition
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 |
|---|---|---|
| Skin staplesDisposable stainless steel skin staples will be used for skin closure following elective laparotomy. Skin closure will be performed according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS), immediately after completion of fascial closure. | Device | Skin Staples |
| Polypropylene skin sutureSkin closure will be performed using interrupted polypropylene (Prolene) sutures following elective laparotomy according to the standard surgical technique of the Department of General Surgery, Pakistan Institute of Medical Sciences (PIMS). | Device | Poly propylene sutures |
Primary outcome
Surgical site infection
Time frame: 30 days
SSI occurring within 30 postoperative days based on CDC clinical criteria with wound culture where indicated.
4 secondary outcomes
Skin closure time
Time frame: During the surgery
Wound Dehiscence
Time frame: 30 days
Post-operative pain
Time frame: 7 days
Scar appearance
Time frame: 6 weeks
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 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin staples and Polypropylene skin suture in people with Surgical Site Infection, run by Pakistan Institute of Medical Sciences 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: looking for participants now, as of the sponsor's last update on 13 Oct 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. 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?
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 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.