Laparotomy Closure After Abdominal SurgeryNCT07451990
Comparison of Vicryl Versus Prolene for Midline Rectus Sheath Closure After Elective Laparotomy
A study testing Vicryl (Polyglactin 910) Suture and Prolene (Polypropylene) Suture in people with Laparotomy Closure After Abdominal Surgery and Suture Materials, run by Hayatabad Medical Complex at 1 site in Pakistan.
Trial summary
This randomized controlled trial compared two commonly used suture materials, Prolene and Vicryl, for closing the midline rectus sheath after elective laparotomy. Proper closure of the abdominal wall is important to reduce complications such as wound dehiscence and surgical site infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparotomy Closure After Abdominal Surgery, Suture Materials, Complications Wounds
- What is being tested?
- Vicryl (Polyglactin 910) Suture and Prolene (Polypropylene) Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 30 Nov 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Patients undergoing elective midline laparotomy
- Ability to provide written informed consent
Who cannot join
- Emergency laparotomy
- Previous abdominal mesh placement
- Immunocompromised patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Vicryl Versus Prolene Sutures in Closure of Midline Rectus Sheath Following Elective Laparotomy: A Randomized Controlled Trial
This randomized controlled trial compared two commonly used suture materials, Prolene and Vicryl, for closing the midline rectus sheath after elective laparotomy. Proper closure of the abdominal wall is important to reduce complications such as wound dehiscence and surgical site infection. Adult patients undergoing elective midline laparotomy were randomly assigned to rectus sheath closure using either Prolene or Vicryl sutures. All patients received the same standardized surgical technique and postoperative care. Participants were followed for 30 days after surgery to assess wound healing, wound dehiscence, surgical site infection, and length of hospital stay. The study aimed to determine which suture material is associated with fewer postoperative wound complications.
Read the detailed description
This prospective randomized controlled trial was conducted in the Department of General Surgery at Hayatabad Medical Complex, Peshawar. The study enrolled adult patients aged 18 to 70 years who underwent elective midline laparotomy for various abdominal conditions. Patients with malnutrition or anemia (hemoglobin < 10 g/dL), immunocompromised states, active infection, pregnancy, prior chemotherapy or radiotherapy, or previous midline laparotomy were excluded.
A total of 152 patients were randomly allocated into two equal groups. Group A underwent midline rectus sheath closure using Prolene 1 (polypropylene, non-absorbable monofilament) suture, while Group B underwent closure using Vicryl 1 (polyglactin 910, absorbable braided) suture. Randomization was performed using a simple randomization method. In both groups, a standardized continuous mass closure technique was used, maintaining a suture-to-wound length ratio of 4:1 with small bites taken at regular intervals. Skin closure was performed using interrupted non-absorbable sutures.
All surgeries were performed under the supervision of senior specialist surgeons, and standard perioperative care, including antibiotic prophylaxis and postoperative wound care, was provided. Patients were followed for 30 days after surgery through inpatient observation and outpatient follow-up visits. Wounds were assessed clinically for evidence of wound dehiscence and surgical site infection.
The primary outcome measure was the incidence of wound dehiscence within 30 days postoperatively. Secondary outcome measures included surgical site infection and length of hospital stay. Data were collected using a structured proforma and analyzed using statistical software. The study was approved by the institutional ethical review board and conducted in accordance with ethical principles for human research.
- Being tested
- Vicryl (Polyglactin 910) Suture, Prolene (Polypropylene) Suture
- Keywords
- Prolene, Vicryl, Laparotomy, Wound Dehiscence, Surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl (Polyglactin 910) SutureDevice
Vicryl (polyglactin 910) is an absorbable braided synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols.
Prolene (Polypropylene) SutureDevice
Prolene (polypropylene) is a non-absorbable monofilament synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Vicryl Suture Group | Experimental | Participants undergoing elective midline laparotomy will have rectus sheath closure performed using Vicryl (polyglactin 910) suture material according to standard surgical technique. Receives: Device: Vicryl (Polyglactin 910) Suture |
| Prolene Suture Group | Active comparator | Participants undergoing elective midline laparotomy will have rectus sheath closure performed using Prolene (polypropylene) suture material according to standard surgical technique. Receives: Device: Prolene (Polypropylene) Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection within 30 Days Post-Laparotomy
Surgical site infection (SSI) is defined as purulent discharge, erythema, or positive microbiology from the incision site within 30 days postoperatively. All infections will be classified and documented according to CDC guidelines.
Measured: 30 days
Incidence of Wound Dehiscence within 30 Days Post-Laparotomy
Wound dehiscence is defined as the separation of the rectus sheath or wound edges, including partial or complete dehiscence, observed within 30 days after midline laparotomy. Clinical examination will be used to assess wound integrity, and findings will be documented in the patient's medical record.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2024
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laparotomy Closure After Abdominal SurgeryStudies 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 undergoing elective midline laparotomy are assigned to one of two parallel groups based on the type of suture material used for rectus sheath closure.
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yousaf Jan, Hayatabad Medical Complex
- Investigators
- Gohar Ali, MBBS, FCPS, Principal investigator, Hayatabad Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451990
- Sponsor's protocol ID
- HMC-RECTUS-2019
- Other IDs
- HMC-QAD-F-2019 / IREB-No.1680
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data, including demographics, surgical details, and postoperative outcomes, will be shared with qualified researchers for scientific research purposes only. Data will be available after publication of the primary results and provided in a secure, de-identified format upon submission of a research proposal and data use agreement.
Publications
Frassini S, Cobianchi L, Fugazzola P, Biffl WL, Coccolini F, Damaskos D, Moore EE, Kluger Y, Ceresoli M, Coimbra R, Davies J, Kirkpatrick A, Di Carlo I, Hardcastle TC, Isik A, Chiarugi M, Gurusamy K, Maier RV, Segovia Lohse HA, Jeekel H, Boermeester MA, Abu-Zidan F, Inaba K, Weber DG, Augustin G, Bonavina L, Velmahos G, Sartelli M, Di Saverio S, Ten Broek RPG, Granieri S, Dal Mas F, Fare CN, Peverada J, Zanghi S, Vigano J, Tomasoni M, Dominioni T, Cicuttin E, Hecker A, Tebala GD, Galante JM, Wani I, Khokha V, Sugrue M, Scalea TM, Tan E, Malangoni MA, Pararas N, Podda M, De Simone B, Ivatury R, Cui Y, Kashuk J, Peitzman A, Kim F, Pikoulis E, Sganga G, Chiara O, Kelly MD, Marzi I, Picetti E, Agnoletti V, De'Angelis N, Campanelli G, de Moya M, Litvin A, Martinez-Perez A, Sall I, Rizoli S, Tomadze G, Sakakushev B, Stahel PF, Civil I, Shelat V, Costa D, Chichom-Mefire A, Latifi R, Chirica M, Amico F, Pardhan A, Seenarain V, Boyapati N, Hatz B, Ackermann T, Abeyasundara S, Fenton L, Plani F, Sarvepalli R, Rouhbakhshfar O, Caleo P, Ho-Ching Yau V, Clement K, Christou E, Castillo AMG, Gosal PKS, Balasubramaniam S, Hsu J, Banphawatanarak K, Pisano M, Adriana T, Michele A, Cioffi SPB, Spota A, Catena F, Ansaloni L. ECLAPTE: Effective Closure of LAParoTomy in Emergency-2023 World Society of Emergency Surgery guidelines for the closure of laparotomy in emergency settings. World J Emerg Surg. 2023 Jul 26;18(1):42. doi: 10.1186/s13017-023-00511-w.
PubMed 37496068Helgeland J, Tomic O, Hansen TM, Kristoffersen DT, Hassani S, Lindahl AK. Postoperative wound dehiscence after laparotomy: a useful healthcare quality indicator? A cohort study based on Norwegian hospital administrative data. BMJ Open. 2019 Apr 3;9(4):e026422. doi: 10.1136/bmjopen-2018-026422.
PubMed 30948604Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.
PubMed 28222776Akbar F, Khan M, Ahmad N, Abbas S, Khan N. Comparison of Laparotomy Wound Dehiscence (LWD) Rate Using Interrupted X-Suture Technique vs Continuous Suture Technique in Rectus Sheath in Emergency Laparotomy. Journal of Saidu Medical College Swat. 2021;11(3):133-6.
Usman Ali Rahman, Muhammad Adil Iftikhar, Mohammad Zia Ul Miraj, Maliha Javaid Butt, Iftikhar Ahmed, Humaira Yousaf. Incidence of wound dehischence and factors causing wound dehiscence in patients undergoing laparotomy in a newly established surgery department at a tertiary care hospital. TPMJ. 2023 Oct 5;30(10):1225-9.
Kunju RD, Thakkannavar V, K SM, G SH, Netto A, J S, et al. A clinical study of continuous and interrupted fascial closure in emergency midline laparotomy at a tertiary care centre. International Surgery Journal. 2017 May 24;4(6):2014-7.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vicryl Versus Prolene Sutures in Closure of Midline Rectus Sheath Following Elective Laparotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07451990
- Acronym / sponsor ID
- HMC-RECTUS-2019
- Keywords
- Prolene, Vicryl, Laparotomy, Wound Dehiscence, Surgical site infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 5 Mar 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 compared two commonly used suture materials, Prolene and Vicryl, for closing the midline rectus sheath after elective laparotomy. Proper closure of the abdominal wall is important to reduce complications such as wound dehiscence and surgical site infection. Adult patients undergoing elective midline laparotomy were randomly assigned to rectus sheath closure using either Prolene or Vicryl sutures. All patients received the same standardized surgical technique and postoperative care. Participants were followed for 30 days after surgery to assess wound healing, wound dehiscence, surgical site infection, and length of hospital stay. The study aimed to determine which suture material is associated with fewer postoperative wound complications.
Detailed description
This prospective randomized controlled trial was conducted in the Department of General Surgery at Hayatabad Medical Complex, Peshawar. The study enrolled adult patients aged 18 to 70 years who underwent elective midline laparotomy for various abdominal conditions. Patients with malnutrition or anemia (hemoglobin < 10 g/dL), immunocompromised states, active infection, pregnancy, prior chemotherapy or radiotherapy, or previous midline laparotomy were excluded.
A total of 152 patients were randomly allocated into two equal groups. Group A underwent midline rectus sheath closure using Prolene 1 (polypropylene, non-absorbable monofilament) suture, while Group B underwent closure using Vicryl 1 (polyglactin 910, absorbable braided) suture. Randomization was performed using a simple randomization method. In both groups, a standardized continuous mass closure technique was used, maintaining a suture-to-wound length ratio of 4:1 with small bites taken at regular intervals. Skin closure was performed using interrupted non-absorbable sutures.
All surgeries were performed under the supervision of senior specialist surgeons, and standard perioperative care, including antibiotic prophylaxis and postoperative wound care, was provided. Patients were followed for 30 days after surgery through inpatient observation and outpatient follow-up visits. Wounds were assessed clinically for evidence of wound dehiscence and surgical site infection.
The primary outcome measure was the incidence of wound dehiscence within 30 days postoperatively. Secondary outcome measures included surgical site infection and length of hospital stay. Data were collected using a structured proforma and analyzed using statistical software. The study was approved by the institutional ethical review board and conducted in accordance with ethical principles for human research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants undergoing elective midline laparotomy are assigned to one of two parallel groups based on the type of suture material used for rectus sheath closure.
| Arm | Type | Receives |
|---|---|---|
| Vicryl Suture Group | Experimental | Device: Vicryl (Polyglactin 910) SutureParticipants undergoing elective midline laparotomy will have rectus sheath closure performed using Vicryl (polyglactin 910) suture material according to standard surgical technique. |
| Prolene Suture Group | Active comparator | Device: Prolene (Polypropylene) SutureParticipants undergoing elective midline laparotomy will have rectus sheath closure performed using Prolene (polypropylene) suture material according to standard surgical technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 70 years
- Patients undergoing elective midline laparotomy
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Emergency laparotomy
- Previous abdominal mesh placement
- Immunocompromised patients
- Pregnant women
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 |
|---|---|---|
| Vicryl (Polyglactin 910) SutureVicryl (polyglactin 910) is an absorbable braided synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols. | Device | Vicryl Suture Group |
| Prolene (Polypropylene) SutureProlene (polypropylene) is a non-absorbable monofilament synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols. | Device | Prolene Suture Group |
Primary outcome
Incidence of Surgical Site Infection within 30 Days Post-Laparotomy
Time frame: 30 days
Surgical site infection (SSI) is defined as purulent discharge, erythema, or positive microbiology from the incision site within 30 days postoperatively. All infections will be classified and documented according to CDC guidelines.
Incidence of Wound Dehiscence within 30 Days Post-Laparotomy
Time frame: 30 days postoperatively
Wound dehiscence is defined as the separation of the rectus sheath or wound edges, including partial or complete dehiscence, observed within 30 days after midline laparotomy. Clinical examination will be used to assess wound integrity, and findings will be documented in the patient's medical record.
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 5 Mar 2026.
- Background: PubMed 37496068Frassini S, Cobianchi L, Fugazzola P, Biffl WL, Coccolini F, Damaskos D, Moore EE, Kluger Y, Ceresoli M, Coimbra R, Davies J, Kirkpatrick A, Di Carlo I, Hardcastle TC, Isik A, Chiarugi M, Gurusamy K, Maier RV, Segovia Lohse HA, Jeekel H, Boermeester MA, Abu-Zidan F, Inaba K, Weber DG, Augustin G, Bonavina L, Velmahos G, Sartelli M, Di Saverio S, Ten Broek RPG, Granieri S, Dal Mas F, Fare CN, Peverada J, Zanghi S, Vigano J, Tomasoni M, Dominioni T, Cicuttin E, Hecker A, Tebala GD, Galante JM, Wani I, Khokha V, Sugrue M, Scalea TM, Tan E, Malangoni MA, Pararas N, Podda M, De Simone B, Ivatury R, Cui Y, Kashuk J, Peitzman A, Kim F, Pikoulis E, Sganga G, Chiara O, Kelly MD, Marzi I, Picetti E, Agnoletti V, De'Angelis N, Campanelli G, de Moya M, Litvin A, Martinez-Perez A, Sall I, Rizoli S, Tomadze G, Sakakushev B, Stahel PF, Civil I, Shelat V, Costa D, Chichom-Mefire A, Latifi R, Chirica M, Amico F, Pardhan A, Seenarain V, Boyapati N, Hatz B, Ackermann T, Abeyasundara S, Fenton L, Plani F, Sarvepalli R, Rouhbakhshfar O, Caleo P, Ho-Ching Yau V, Clement K, Christou E, Castillo AMG, Gosal PKS, Balasubramaniam S, Hsu J, Banphawatanarak K, Pisano M, Adriana T, Michele A, Cioffi SPB, Spota A, Catena F, Ansaloni L. ECLAPTE: Effective Closure of LAParoTomy in Emergency-2023 World Society of Emergency Surgery guidelines for the closure of laparotomy in emergency settings. World J Emerg Surg. 2023 Jul 26;18(1):42. doi: 10.1186/s13017-023-00511-w.
- Results publication: PubMed 30948604Helgeland J, Tomic O, Hansen TM, Kristoffersen DT, Hassani S, Lindahl AK. Postoperative wound dehiscence after laparotomy: a useful healthcare quality indicator? A cohort study based on Norwegian hospital administrative data. BMJ Open. 2019 Apr 3;9(4):e026422. doi: 10.1136/bmjopen-2018-026422.
- Results publication: PubMed 28222776Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.
- Results publicationAkbar F, Khan M, Ahmad N, Abbas S, Khan N. Comparison of Laparotomy Wound Dehiscence (LWD) Rate Using Interrupted X-Suture Technique vs Continuous Suture Technique in Rectus Sheath in Emergency Laparotomy. Journal of Saidu Medical College Swat. 2021;11(3):133-6.
- Results publicationUsman Ali Rahman, Muhammad Adil Iftikhar, Mohammad Zia Ul Miraj, Maliha Javaid Butt, Iftikhar Ahmed, Humaira Yousaf. Incidence of wound dehischence and factors causing wound dehiscence in patients undergoing laparotomy in a newly established surgery department at a tertiary care hospital. TPMJ. 2023 Oct 5;30(10):1225-9.
- Results publicationKunju RD, Thakkannavar V, K SM, G SH, Netto A, J S, et al. A clinical study of continuous and interrupted fascial closure in emergency midline laparotomy at a tertiary care centre. International Surgery Journal. 2017 May 24;4(6):2014-7.
- Lakshmi G, Ravimohan TR. Post Laparotomy Abdominal Wound Dehisence - A Study in Tertiary Care Hospital. IJCMR \[Internet\]. 2018 Nov \[cited 2025 Nov 5\];5(11). Available from: https://www.ijcmr.com/uploads/7/7/4/6/77464738/ijcmr\_2208\_v1.pdfLink provided by the sponsor.
- Alam I, Amin S, Iqbal S, Samad M, Tahir R. THE FREQUENCY OF WOUND DEHISCENCE IN ADULTS UNDERGOING MIDLINE EXPLORATORY LAPAROTOMY IN A TERTIARY CARE HOSPITAL IN PESHAWAR. NORTHWEST JOURNAL OF MEDICAL SCIENCES \[Internet\]. 2025 Sept 30 \[cited 2025 Nov 4\];4(Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data, including demographics, surgical details, and postoperative outcomes, will be shared with qualified researchers for scientific research purposes only. Data will be available after publication of the primary results and provided in a secure, de-identified format upon submission of a research proposal and data use agreement.
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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.
Gohar Ali, MBBS, FCPS principal investigator
Hayatabad Medical Complex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl (Polyglactin 910) Suture and Prolene (Polypropylene) Suture in people with Laparotomy Closure After Abdominal Surgery and Suture Materials, run by Hayatabad Medical Complex 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 3 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 5 Mar 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?
Incidence of Surgical Site Infection within 30 Days Post-Laparotomy (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT07451990, which also lists 6 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 5 Mar 2026.