SuturesNCT07274878
Interrupted vs Subcuticular Sutures With Drain in Open Appendectomy
A study testing subcuticular suture plus subcutaneous drain in people with Sutures, run by Assiut University.
Trial summary
The primary aim of this study is to compare wound outcomes between two closure strategies after open appendectomy: 1. Simple interrupted skin sutures (standard method), versus 2. Subcuticular (intradermal) skin suture combined with a subcutaneous closed suction drain. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Sutures
- What is being tested?
- subcuticular suture plus subcutaneous drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 14 years (or per local ethics), undergoing open appendectomy for acute appendicitis (elective not included).
- Skin incision for open appendectomy (McBurney/Gridiron or Lanz).
- Patient (or legal guardian) able and willing to provide informed consent.
Who cannot join
- Laparoscopic appendectomy or conversion to laparoscopic approach.
- Previous abdominal surgery at the same site (risk of altered wound healing).
- Pre-existing skin infection at the surgical site.
About this study
Official title: Simple Interrupted Skin Sutures Versus Subcuticular Suture Plus Subcutaneous Drain for Wound Outcomes After Open Appendectomy
The primary aim of this study is to compare wound outcomes between two closure strategies after open appendectomy:
- Simple interrupted skin sutures (standard method), versus
- Subcuticular (intradermal) skin suture combined with a subcutaneous closed suction drain.
Read more
Specifically, the study aims to
- Determine whether the combined subcuticular closure with drain reduces the incidence of superficial surgical- site infection (SSI) within 30 days compared with interrupted sutures.
- Evaluate the effect of both techniques on secondary outcomes, including seroma or abscess formation, wound dehiscence, post-operative pain, cosmetic appearance of the scar, length of hospital stay, and drain-related adverse events.
Read the detailed description
Open appendectomy remains a common emergency operation worldwide, particularly in settings where laparoscopic surgery is not feasible. Post-operative wound complications - especially superficial surgical-site infection (SSI), seroma and dehiscence - are frequent and lead to pain, longer hospital stay, antibiotic use and higher costs.
Reported SSI rates after appendectomy vary, but pooled global data suggest about 7 infections per 100 appendectomies, with higher rates generally seen after open procedures compared to laparoscopic approaches.
Skin closure technique is one modifiable factor influencing wound outcomes. Simple interrupted non-absorbable sutures are widely used, but continuous intradermal (subcuticular) absorbable sutures are increasingly studied. Randomized trials and systematic reviews show that subcuticular closure is at least as safe as interrupted closure regarding SSI, while often offering advantages such as improved cosmetic results, reduced need for suture removal, and lower patient discomfort.
A notable randomized trial in open appendectomy found fewer wound complications and better patient-reported outcomes with intradermal closure, though evidence across studies remains heterogeneous.
Placement of a subcutaneous closed suction drain is another potential strategy to reduce dead space and fluid collections, thereby lowering risks of seroma and infection. Meta-analyses suggest possible reductions in SSI and length of stay in abdominal surgery, but results are inconsistent and routine use remains controversial.
Current WHO guidelines on SSI prevention do not recommend a universal closure technique or routine subcutaneous drains, highlighting the need for targeted evidence.
Thus, the comparative effectiveness of simple interrupted sutures versus subcuticular closure combined with a subcutaneous drain in open appendectomy remains unclear, justifying a randomized controlled trial to address this gap.
- Conditions
- Sutures
- Being tested
- subcuticular suture plus subcutaneous drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcuticular suture plus subcutaneous drainProcedure or surgery
Subcuticular suture plus subcutaneous drain uses a continuous absorbable subcuticular stitch combined with a drain placed in the subcutaneous layer to reduce dead space and fluid collection-offering both cosmetic closure and added infection-prevention compared with standard skin-only techniques.
| Study group | Role | What they receive |
|---|---|---|
| subcuticular suture plus subcutaneous drain | Experimental | Not described Receives: Procedure: subcuticular suture plus subcutaneous drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of superficial surgical-site infection (SSI)
Incidence of superficial surgical-site infection (SSI) after open appendectomy, defined according to CDC/NHSN criteria (purulent drainage, positive culture, or surgeon diagnosis).
Measured: 30 days
Secondary outcomes (2)
Incidence of other wound-related complications
- Seroma or subcutaneous abscess formation.
- Wound dehiscence (partial or complete).
- Drain-site infection or complications
Measured: 30 days
Postoperative pain
measured using the Visual Analogue Scale (VAS, 0-10 cm)
Measured: at 24 hours, 48 hours, and 7-10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
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 SuturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Rajab Abdulwahab Abdulwahab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274878
- Sponsor's protocol ID
- IVSSDOART
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Danwang C, Bigna JJ, Tochie JN, Mbonda A, Mbanga CM, Nzalie RNT, Guifo ML, Essomba A. Global incidence of surgical site infection after appendectomy: a systematic review and meta-analysis. BMJ Open. 2020 Feb 18;10(2):e034266. doi: 10.1136/bmjopen-2019-034266.
PubMed 32075838Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e276-e287. doi: 10.1016/S1473-3099(16)30398-X. Epub 2016 Nov 2.
PubMed 27816413Ishinuki T, Shinkawa H, Kouzu K, Shinji S, Goda E, Ohyanagi T, Kobayashi M, Kobayashi M, Suzuki K, Kitagawa Y, Yamashita C, Mohri Y, Shimizu J, Uchino M, Haji S, Yoshida M, Ohge H, Mayumi T, Mizuguchi T. Recent evidence for subcutaneous drains to prevent surgical site infections after abdominal surgery: A systematic review and meta-analysis. World J Gastrointest Surg. 2023 Dec 27;15(12):2879-2889. doi: 10.4240/wjgs.v15.i12.2879.
PubMed 38222020Andrade LA, Munoz FY, Baez MV, Collazos SS, de Los Angeles Martinez Ferretiz M, Ruiz B, Montes O, Woolf S, Noriega JG, Aparicio UM, Gonzalez IG. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC). World J Surg. 2016 Nov;40(11):2603-2610. doi: 10.1007/s00268-016-3607-x.
PubMed 27283187Imamura K, Adachi K, Sasaki R, Monma S, Shioiri S, Seyama Y, Miura M, Morikawa Y, Kaneko T. Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial. J Gastrointest Surg. 2016 Dec;20(12):2083-2092. doi: 10.1007/s11605-016-3283-z. Epub 2016 Oct 3.
PubMed 27699563Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
PubMed 26460662
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Interrupted Skin Sutures Versus Subcuticular Suture Plus Subcutaneous Drain for Wound Outcomes After Open Appendectomy
- ClinicalTrials.gov ID
- NCT07274878
- Acronym / sponsor ID
- IVSSDOART
- Conditions
- Sutures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Dec 2025 (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.
The primary aim of this study is to compare wound outcomes between two closure strategies after open appendectomy:
- Simple interrupted skin sutures (standard method), versus
- Subcuticular (intradermal) skin suture combined with a subcutaneous closed suction drain.
Specifically, the study aims to
- Determine whether the combined subcuticular closure with drain reduces the incidence of superficial surgical- site infection (SSI) within 30 days compared with interrupted sutures.
- Evaluate the effect of both techniques on secondary outcomes, including seroma or abscess formation, wound dehiscence, post-operative pain, cosmetic appearance of the scar, length of hospital stay, and drain-related adverse events.
Detailed description
Open appendectomy remains a common emergency operation worldwide, particularly in settings where laparoscopic surgery is not feasible. Post-operative wound complications - especially superficial surgical-site infection (SSI), seroma and dehiscence - are frequent and lead to pain, longer hospital stay, antibiotic use and higher costs.
Reported SSI rates after appendectomy vary, but pooled global data suggest about 7 infections per 100 appendectomies, with higher rates generally seen after open procedures compared to laparoscopic approaches.
Skin closure technique is one modifiable factor influencing wound outcomes. Simple interrupted non-absorbable sutures are widely used, but continuous intradermal (subcuticular) absorbable sutures are increasingly studied. Randomized trials and systematic reviews show that subcuticular closure is at least as safe as interrupted closure regarding SSI, while often offering advantages such as improved cosmetic results, reduced need for suture removal, and lower patient discomfort.
A notable randomized trial in open appendectomy found fewer wound complications and better patient-reported outcomes with intradermal closure, though evidence across studies remains heterogeneous.
Placement of a subcutaneous closed suction drain is another potential strategy to reduce dead space and fluid collections, thereby lowering risks of seroma and infection. Meta-analyses suggest possible reductions in SSI and length of stay in abdominal surgery, but results are inconsistent and routine use remains controversial.
Current WHO guidelines on SSI prevention do not recommend a universal closure technique or routine subcutaneous drains, highlighting the need for targeted evidence.
Thus, the comparative effectiveness of simple interrupted sutures versus subcuticular closure combined with a subcutaneous drain in open appendectomy remains unclear, justifying a randomized controlled trial to address this gap.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcuticular suture plus subcutaneous drain | Experimental | Procedure: subcuticular suture plus subcutaneous drain |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 14 years (or per local ethics), undergoing open appendectomy for acute appendicitis (elective not included).
- Skin incision for open appendectomy (McBurney/Gridiron or Lanz).
- Patient (or legal guardian) able and willing to provide informed consent.
Key exclusion criteria (3 listed)
- Laparoscopic appendectomy or conversion to laparoscopic approach.
- Previous abdominal surgery at the same site (risk of altered wound healing).
- Pre-existing skin infection at the surgical site.
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 |
|---|---|---|
| subcuticular suture plus subcutaneous drainSubcuticular suture plus subcutaneous drain uses a continuous absorbable subcuticular stitch combined with a drain placed in the subcutaneous layer to reduce dead space and fluid collection-offering both cosmetic closure and added infection-prevention compared with standard skin-only techniques. | Procedure or surgery | subcuticular suture plus subcutaneous drain |
Primary outcome
Incidence of superficial surgical-site infection (SSI)
Time frame: 30 days
Incidence of superficial surgical-site infection (SSI) after open appendectomy, defined according to CDC/NHSN criteria (purulent drainage, positive culture, or surgeon diagnosis).
2 secondary outcomes
Incidence of other wound-related complications
Time frame: 30 days
Postoperative pain
Time frame: at 24 hours, 48 hours, and 7-10days
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 10 Dec 2025.
- Results publication: PubMed 32075838Danwang C, Bigna JJ, Tochie JN, Mbonda A, Mbanga CM, Nzalie RNT, Guifo ML, Essomba A. Global incidence of surgical site infection after appendectomy: a systematic review and meta-analysis. BMJ Open. 2020 Feb 18;10(2):e034266. doi: 10.1136/bmjopen-2019-034266.
- Results publication: PubMed 27816413Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e276-e287. doi: 10.1016/S1473-3099(16)30398-X. Epub 2016 Nov 2.
- Results publication: PubMed 38222020Ishinuki T, Shinkawa H, Kouzu K, Shinji S, Goda E, Ohyanagi T, Kobayashi M, Kobayashi M, Suzuki K, Kitagawa Y, Yamashita C, Mohri Y, Shimizu J, Uchino M, Haji S, Yoshida M, Ohge H, Mayumi T, Mizuguchi T. Recent evidence for subcutaneous drains to prevent surgical site infections after abdominal surgery: A systematic review and meta-analysis. World J Gastrointest Surg. 2023 Dec 27;15(12):2879-2889. doi: 10.4240/wjgs.v15.i12.2879.
- Results publication: PubMed 27283187Andrade LA, Munoz FY, Baez MV, Collazos SS, de Los Angeles Martinez Ferretiz M, Ruiz B, Montes O, Woolf S, Noriega JG, Aparicio UM, Gonzalez IG. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC). World J Surg. 2016 Nov;40(11):2603-2610. doi: 10.1007/s00268-016-3607-x.
- Results publication: PubMed 27699563Imamura K, Adachi K, Sasaki R, Monma S, Shioiri S, Seyama Y, Miura M, Morikawa Y, Kaneko T. Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial. J Gastrointest Surg. 2016 Dec;20(12):2083-2092. doi: 10.1007/s11605-016-3283-z. Epub 2016 Oct 3.
- Results publication: PubMed 26460662Bhangu A, Soreide K, Di Saverio S, Assarsson JH, Drake FT. Acute appendicitis: modern understanding of pathogenesis, diagnosis, and management. Lancet. 2015 Sep 26;386(10000):1278-1287. doi: 10.1016/S0140-6736(15)00275-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing subcuticular suture plus subcutaneous drain in people with Sutures, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 superficial surgical-site infection (SSI) (time frame: 30 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 NCT07274878, 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 10 Dec 2025.