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| ID | Type | Description | Link |
|---|---|---|---|
| HMC-QAD-F-2019 / IREB-No.1680 | Other Identifier | Ethical committe Hayatabad Medical Complex |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicryl (Polyglactin 910) Suture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gohar Ali, MBBS, FCPS | Hayatabad Medical Complex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hayatabad Medical Complex, Peshawar | Peshawar | KPK | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37496068 | Background | 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. | |
| Label | URL |
|---|---|
| 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.pdf | View source |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2024 | Mar 1, 2026 |
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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.
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This is an open-label study as the operating surgeon is aware of the suture material used.
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| Prolene (Polypropylene) Suture | Device | 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. |
|
| 30948604 |
| Result |
| Helgeland 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. |
| 28222776 | Result | Walming 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. |
| Result | Akbar 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. |
| Result | 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. |
| Result | 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. |
| 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( | View source |
| Related Info | View source |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2024 | Feb 16, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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