Surgical Site InfectionPOLYNOVO-CHDNCT05966961
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
An observational study of Surgical Site Infection, run by Aesculap AG at 4 sites in 2 countries.
Trial summary
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery and Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2,998 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 18 Sep 2023to Dec 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery
Who may be able to join
- Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
Who cannot join
- No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Ricard Rosique contact
4 sites in 2 countries
Spain3 sites, 3 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid
Antonio José Torres Garcia, Dr.
Antonio José Torres Garcia, Dr.
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Javier River Castellano, Dr.
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
Javier Pardillo Ruiz, Dr.
Italy1 site, 1 recruiting
- Recruiting
Pineta Grande Hospital
Naples
Francesco Stanzione, Dr.
About this study
Official title: 'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.
- Conditions
- Surgical Site Infection
- Being tested
- Novosyn® in emergency or elective laparotomy or laparoscopic surgery, Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
- Keywords
- Chlorhexidine coated suture, emergency laparoscopic surgery, emergency laparotomy surgery, elective laparoscopic surgery, elective laparotomy surgery, Novosyn®, Polyglactin 910
- 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.
Novosyn® in emergency or elective laparotomy or laparoscopic surgeryDevice
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgeryDevice
Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Novosyn® | Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine Receives: Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery | |
| Polyglactin 910 | Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine Receives: Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of surgical site infection (superficial (A1) and deep (A2)
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).
Measured: until 30 days + 5 days after surgery.
Secondary outcomes (10)
Handling of the suture material
Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).
Measured: intraoperatively
Length of hospital stay
Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery
Measured: until discharge (approximately 10 days after surgery)
Time to return to work
Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery
Measured: until 30 days + 5 days after surgery.
Incidence of Surgical Site Infection (SSI)
Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge
Measured: at discharge (approximately 10 days after surgery)
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected)
Measured: until 30 days + 5 days after surgery
Cumulative Rate of postoperative complications
Number of postoperative complications of any kind for descriptive analysis
Measured: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
Cumulative Rate of reoperation
Number of reoperation of any kind for descriptive analysis
Measured: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of suture removal due to wound problems
Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis
Measured: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of Re-suturing
Rate of Re-suturing of any kind for descriptive analysis
Measured: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Hernia rate
Number of Wound Hernia including umbilical hernia verified by ultra-sound examination
Measured: 30 days + 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start18 Sep 2023
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,998 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Antonio José Torres Garcia, Prof. Dr., Principal investigator, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966961
- Sponsor's protocol ID
- AAG-G-H-2201
- Acronym
- POLYNOVO-CHD
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05966961
- Acronym / sponsor ID
- POLYNOVO-CHD / AAG-G-H-2201
- Conditions
- Surgical Site Infection
- Keywords
- Chlorhexidine coated suture, emergency laparoscopic surgery, emergency laparotomy surgery, elective laparoscopic surgery, elective laparotomy surgery, Novosyn®, Polyglactin 910
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,998 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Aug 2023 (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 aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novosyn® | – | Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgerySutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine |
| Polyglactin 910 | – | Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgerySutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery
Key inclusion criteria (4 listed)
- Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.
- Written informed consent
- Age≥ 18 years
- Not incapacitated patient
Key exclusion criteria (1 listed)
- No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine
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 |
|---|---|---|
| Novosyn® in emergency or elective laparotomy or laparoscopic surgeryFascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery. | Device | Novosyn® |
| Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgeryFascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery. | Device | Polyglactin 910 |
Primary outcome
Frequency of surgical site infection (superficial (A1) and deep (A2)
Time frame: until 30 days + 5 days after surgery.
The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).
10 secondary outcomes
Handling of the suture material
Time frame: intraoperatively
Length of hospital stay
Time frame: until discharge (approximately 10 days after surgery)
Time to return to work
Time frame: until 30 days + 5 days after surgery.
Incidence of Surgical Site Infection (SSI)
Time frame: at discharge (approximately 10 days after surgery)
Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class
Time frame: until 30 days + 5 days after surgery
Cumulative Rate of postoperative complications
Time frame: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
Cumulative Rate of reoperation
Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of suture removal due to wound problems
Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Cumulative Rate of Re-suturing
Time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
Hernia rate
Time frame: 30 days + 5 days postoperatively
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Ricard Rosique contact
Antonio José Torres Garcia, Prof. Dr. principal investigator
Hospital San Carlos, Madrid
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Aesculap AG at 4 sites in 2 countries.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 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 4 sites in Spain, Italy. 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?
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?
Contact Jaume Garcia Lopez (+34935866200, info@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of surgical site infection (superficial (A1) and deep (A2) (time frame: until 30 days + 5 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2026.