An interventional study of Skin staples and Polypropylene skin suture in Surgical Site Infection, sponsored by Pakistan Institute of Medical Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Pakistan Institute of Medical Sciences · Not applicable, Interventional, and Treatment
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 130 is below the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Pakistan Institute of Medical Sciences is the lead sponsor of 55 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 15-50 years Elective laparotomy Written Male or female
Exclusion Criteria:
Emergency surgery Previous SSI Recurrent surgery \<18 or >30 kg/m² \<10 g/dL Stroke Renal failure Liver disease Haematological disorders state Active infection Previous chemotherapy Previous radiotherapy Malnutrition
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Skin closure performed using disposable stainless steel skin staples.
Device: Skin staples
Skin closure performed using interrupted polypropylene (Prolene) sutures.
Device: Polypropylene skin suture
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.
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).
Surgical site infection
SSI occurring within 30 postoperative days based on CDC clinical criteria with wound culture where indicated.
Time frame: 30 days
Skin closure time
Measured in seconds from the first skin puncture until completion of skin closure.
Time frame: During the surgery
Wound Dehiscence
Giving way of the skin closure leading to exposure of subcutaneous tissues.
Time frame: 30 days
Post-operative pain
Pain scored on verbal descriptor scale from 1 to 10
Time frame: 7 days
Scar appearance
Visual description of scar on analogue scsle by subjective assessment(1-10)
Time frame: 6 weeks
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 11 months is below that.
Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Pakistan Institute of Medical Sciences