Abdominal HerniaNCT06644612
Light vs Heavy Weighted Mesh Repair in Primary Abdominal Hernia in Terms of Surgical Site Infection
A study testing Light Weight Mesh and Heavy Weight Mesh in people with Abdominal Hernia, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial summary
This study compares the incidence of surgical site infections (SSI) in patients undergoing abdominal hernia repair using either light or heavy-weighted polypropylene mesh. The study aims to determine which mesh type results in fewer SSIs, thereby guiding future surgical approaches to abdominal hernia repair. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Abdominal Hernia
- What is being tested?
- Light Weight Mesh and Heavy Weight Mesh
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2024to 15 Apr 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 15 and above.
- Patients undergoing primary abdominal hernia repair using light or heavy mesh.
Who cannot join
- Patients with incisional hernias.
- Patients with diabetes mellitus, chronic cough, steroid use, cancer, or immune-compromised status.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lady Reading Hospital, Pakistan
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: A Comparative Study of Light vs Heavy Weighted Polypropylene Mesh in Abdominal Hernia Repair: A Randomized Control Trial Focusing on Surgical Site Infections
This study compares the incidence of surgical site infections (SSI) in patients undergoing abdominal hernia repair using either light or heavy-weighted polypropylene mesh. The study aims to determine which mesh type results in fewer SSIs, thereby guiding future surgical approaches to abdominal hernia repair.
Read the detailed description
Hernias, a protrusion of abdominal contents through the abdominal wall, are often treated surgically using synthetic polypropylene mesh. Two varieties of polypropylene mesh exist: light and heavy weighted. The lighter mesh is softer, less allergenic, and potentially leads to fewer post-surgical complications, including SSIs. In contrast, heavier mesh, which has been traditionally used, consists of thicker threads with narrower gaps and has a higher chance of eliciting an immune response. This trial aims to assess the effectiveness of light mesh over heavy mesh in reducing SSIs in abdominal hernia repairs, thereby providing data to support best practices in surgical care.
- Conditions
- Abdominal Hernia
- Being tested
- Light Weight Mesh, Heavy Weight Mesh
- Keywords
- Abdominal Hernia, Surgical Site Infection, Light Weighted Mesh, Heavy Weighted Mesh, Randomized Controlled Trial
- Medical subject headings
- Hernia, Abdominal, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Weight MeshProcedure or surgery
Participants will undergo abdominal hernia repair using light-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.
Heavy Weight MeshProcedure or surgery
Participants will undergo abdominal hernia repair using heavy-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group A (Light Mesh Group) | Experimental | All the patients will be administered intravenous Antibiotics two hours before induction of anaesthesia. The surgical site will be shaved if needed after scrubbing the patient. Prolene suture material will be used to anchor the light mesh and suture the skin. A negative pressure drain will be placed if needed. The wound will be dressed with gauze dressing. Post-operatively daily dressing will be done by ward dispenser following full aseptic technique. Receives: Procedure: Light Weight Mesh |
| Intervention Group B (Heavy Mesh Group) | Active comparator | All the patients will be administered intravenous antibiotics two hours before induction of anaesthesia. The surgical site will be shaved if needed after scrubbing the patient.
Prolene suture material will be used for anchoring the Heavy mesh and for suturing the skin. A negative pressure drain will be placed if needed. The wound will be dressed with a gauze dressing. Post-operatively daily dressing will be done by ward dispenser following full aseptic technique. Receives: Procedure: Heavy Weight Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI)
Incidence of Surgical Site Infection (SSI) within 10 days post-surgery. Using Complete Blood Count (CBC) and site of infection will be checked for the structure affected.
Measured: 10 days
Secondary outcomes (1)
Post-operative Pain
Post-operative pain severity measured using a standardized pain scale (Visual Analogue Scale). Higher scores indicate more severe pain. Scores are interpreted are from 0-4: Mild pain 5-7: Moderate pain, 7-10: Severe pain
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Aug 2024
- Primary completion28 Feb 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal HerniaStudies 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 will be randomly allocated into two groups: one group will undergo hernia repair using light-weighted polypropylene mesh, and the other group will receive heavy-weighted polypropylene mesh. The incidence of SSIs post-operatively will be compared between the two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- Lady Reading Hospital, Pakistan
- Responsible party
- Principal investigator, Dr Sheraz Fazid, Khyber Medical University Peshawar
- Investigators
- Dr Abdul Wahab, Principal investigator, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644612
- Sponsor's protocol ID
- KMU/DIR/CTU/2024/008
- Status last verified
- Aug 2025
- First submitted
- 14 Oct 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.
Publications
Ponten JEH, Leclercq WKG, Lettinga T, Heemskerk J, Konsten JLM, Bouvy ND, Nienhuijs SW. Mesh OR Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS-Trial): The Complete Two-year Follow-up. Ann Surg. 2019 Jul;270(1):33-37. doi: 10.1097/SLA.0000000000003086.
PubMed 30339623Rastegarpour A, Cheung M, Vardhan M, Ibrahim MM, Butler CE, Levinson H. Surgical mesh for ventral incisional hernia repairs: Understanding mesh design. Plast Surg (Oakv). 2016 Spring;24(1):41-50. doi: 10.4172/plastic-surgery.1000955.
PubMed 27054138Eriksen JR, Gogenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia. 2007 Dec;11(6):481-92. doi: 10.1007/s10029-007-0282-8. Epub 2007 Sep 11.
PubMed 17846703
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Light vs Heavy Weighted Polypropylene Mesh in Abdominal Hernia Repair: A Randomized Control Trial Focusing on Surgical Site Infections
- ClinicalTrials.gov ID
- NCT06644612
- Acronym / sponsor ID
- KMU/DIR/CTU/2024/008
- Conditions
- Abdominal Hernia
- Keywords
- Abdominal Hernia, Surgical Site Infection, Light Weighted Mesh, Heavy Weighted Mesh, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- Lady Reading Hospital, Pakistan
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 16 Oct 2024 (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 study compares the incidence of surgical site infections (SSI) in patients undergoing abdominal hernia repair using either light or heavy-weighted polypropylene mesh. The study aims to determine which mesh type results in fewer SSIs, thereby guiding future surgical approaches to abdominal hernia repair.
Detailed description
Hernias, a protrusion of abdominal contents through the abdominal wall, are often treated surgically using synthetic polypropylene mesh. Two varieties of polypropylene mesh exist: light and heavy weighted. The lighter mesh is softer, less allergenic, and potentially leads to fewer post-surgical complications, including SSIs. In contrast, heavier mesh, which has been traditionally used, consists of thicker threads with narrower gaps and has a higher chance of eliciting an immune response. This trial aims to assess the effectiveness of light mesh over heavy mesh in reducing SSIs in abdominal hernia repairs, thereby providing data to support best practices in surgical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated into two groups: one group will undergo hernia repair using light-weighted polypropylene mesh, and the other group will receive heavy-weighted polypropylene mesh. The incidence of SSIs post-operatively will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group A (Light Mesh Group) | Experimental | Procedure: Light Weight MeshAll the patients will be administered intravenous Antibiotics two hours before induction of anaesthesia. The surgical site will be shaved if needed after scrubbing the patient. Prolene suture material will be used to anchor the light mesh and suture the skin. A negative pressure drain will be placed if needed. The wound will be dressed with gauze dressing. Post-operatively daily dressing will be done by ward dispenser following full aseptic technique. |
| Intervention Group B (Heavy Mesh Group) | Active comparator | Procedure: Heavy Weight MeshAll the patients will be administered intravenous antibiotics two hours before induction of anaesthesia. The surgical site will be shaved if needed after scrubbing the patient. Prolene suture material will be used for anchoring the Heavy mesh and for suturing the skin. A negative pressure drain will be placed if needed. The wound will be dressed with a gauze dressing. Post-operatively daily dressing will be done by ward dispenser following full aseptic technique. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 15 and above.
- Patients undergoing primary abdominal hernia repair using light or heavy mesh.
Key exclusion criteria (2 listed)
- Patients with incisional hernias.
- Patients with diabetes mellitus, chronic cough, steroid use, cancer, or immune-compromised status.
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 |
|---|---|---|
| Light Weight MeshParticipants will undergo abdominal hernia repair using light-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided. | Procedure or surgery | Intervention Group A (Light Mesh Group) |
| Heavy Weight MeshParticipants will undergo abdominal hernia repair using heavy-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided. | Procedure or surgery | Intervention Group B (Heavy Mesh Group) |
Primary outcome
Surgical Site Infection (SSI)
Time frame: 10 days
Incidence of Surgical Site Infection (SSI) within 10 days post-surgery. Using Complete Blood Count (CBC) and site of infection will be checked for the structure affected.
1 secondary outcome
Post-operative Pain
Time frame: 10 days
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 2 Sep 2025.
- Background: PubMed 30339623Ponten JEH, Leclercq WKG, Lettinga T, Heemskerk J, Konsten JLM, Bouvy ND, Nienhuijs SW. Mesh OR Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS-Trial): The Complete Two-year Follow-up. Ann Surg. 2019 Jul;270(1):33-37. doi: 10.1097/SLA.0000000000003086.
- Background: PubMed 27054138Rastegarpour A, Cheung M, Vardhan M, Ibrahim MM, Butler CE, Levinson H. Surgical mesh for ventral incisional hernia repairs: Understanding mesh design. Plast Surg (Oakv). 2016 Spring;24(1):41-50. doi: 10.4172/plastic-surgery.1000955.
- Background: PubMed 17846703Eriksen JR, Gogenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia. 2007 Dec;11(6):481-92. doi: 10.1007/s10029-007-0282-8. Epub 2007 Sep 11.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.
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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.
Dr Abdul Wahab principal investigator
Lady Reading Hospital, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light Weight Mesh and Heavy Weight Mesh in people with Abdominal Hernia, run by Khyber Medical University Peshawar 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 2 inclusion and 2 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 2 Sep 2025. 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?
Surgical Site Infection (SSI) (time frame: 10 days). 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 NCT06644612, which also lists 3 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 2 Sep 2025.