Surgical WoundNCT03716687
Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.
A study testing Prophylactic negative pressure wound dressing after laparotomy in people with Surgical Wound and Wound Dehiscence, Surgical, run by St. Borbala Hospital at 1 site in Hungary.
Trial summary
Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Wound, Wound Dehiscence, Surgical, Surgical Site Infection
- What is being tested?
- Prophylactic negative pressure wound dressing after laparotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Nov 2018to 1 Sep 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
- Surgical wound type III or IV..
Who cannot join
- Patients not giving informed consent.
- Patients requiring open abdominal wound care.
- Patients with abdominal wall malignancy,
- Patients with peritoneal carcinomatosis,
- Patients who are planned for second look laparotomy within 5 days,
- Patients with less thank 3 month life expectancy.
- Patients who are operated with existing wound infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.
Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.
NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.
In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.
Read the detailed description
The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.
Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.
Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).
A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.
Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.
- Conditions
- Surgical Wound, Wound Dehiscence, Surgical, Surgical Site Infection, Dehiscence of Internal Surgical Wound
- Being tested
- Prophylactic negative pressure wound dressing after laparotomy
- Keywords
- negative pressure wound closure, surgical site infection, cost effectiveness
- Medical subject headings
- Surgical Wound, Surgical Wound Dehiscence, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic negative pressure wound dressing after laparotomyDevice
Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.
| Study group | Role | What they receive |
|---|---|---|
| ciNPWT | Experimental | Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation.
Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed. Receives: Device: Prophylactic negative pressure wound dressing after laparotomy |
| Traditional wound dressing | No intervention | Control group with traditional, dry laparotomy wound dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)
Measured: 30 days
Secondary outcomes (1)
Full thickness abdominal wall dehiscence, requiring re-operation
Full thickness abdominal wall dehiscence, requiring re-operation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Sep 2020
Why it stopped: No chance to enroll sufficient cases. Several coinvestigator centers have never started recruiting.
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 Surgical WoundStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50-50% randomisation into interventional (ciNPWT) and control (traditionaltreatment) groups.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Borbala Hospital
- Sponsor type
- Other government
- Collaborators
- Semmelweis University, Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest, Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár, Institute of Surgery, University of Debrecen, Department of Surgery, University of Szeged, Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest, Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely, Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét, Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen, Department of Surgery, Szent Rókus Kórház, Baja, Department of Surgery, St. Borbala hospital, Tatabanya
- Responsible party
- Principal investigator, Dr. Balázs Bánky PhD, St. Borbala Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716687
- Sponsor's protocol ID
- OGYÉI/15347-9/2018
- Status last verified
- Mar 2021
- First submitted
- 21 Oct 2018
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahebally SM, McKevitt K, Stephens I, Fitzpatrick F, Deasy J, Burke JP, McNamara D. Negative Pressure Wound Therapy for Closed Laparotomy Incisions in General and Colorectal Surgery: A Systematic Review and Meta-analysis. JAMA Surg. 2018 Nov 1;153(11):e183467. doi: 10.1001/jamasurg.2018.3467. Epub 2018 Nov 21.
PubMed 30267040Curran T, Alvarez D, Pastrana Del Valle J, Cataldo TE, Poylin V, Nagle D. Prophylactic closed-incision negative-pressure wound therapy is associated with decreased surgical site infection in high-risk colorectal surgery laparotomy wounds. Colorectal Dis. 2019 Jan;21(1):110-118. doi: 10.1111/codi.14350. Epub 2018 Aug 20.
PubMed 30047611Gachabayov M, You K, Sullivan R, Bergamaschi R. A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery. Ostomy Wound Manage. 2018 Apr;64(4):22-29.
PubMed 29718814Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.
PubMed 28885895Athanasiou AN, Spartalis M, Spartalis E. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds After Abdominal Operations: What We Really Know? Ann Surg. 2018 Jul;268(1):e19-e20. doi: 10.1097/SLA.0000000000002413. No abstract available.
PubMed 28692475Herczeg A, Szijarto A, Fulop A, Varga K, Marton J, Loderer Z, Mohos B, Pancel B, Szendrenyi V, Lazar G, Libor L, Kaposztas Z, Mathe E, Bursics A, Kecskedi B, Sikorszki L, Venczel L, Banky B. Prophylactic Negative Pressure Wound Therapy Reduces Superficial Surgical Site Infection Risk of Emergency Surgery Patients: Results of a Multicenter Randomised Prospective Clinical Trial. Int Wound J. 2025 Jul;22(7):e70718. doi: 10.1111/iwj.70718.
PubMed 40605477
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.
- ClinicalTrials.gov ID
- NCT03716687
- Acronym / sponsor ID
- OGYÉI/15347-9/2018
- Conditions
- Surgical Wound, Wound Dehiscence, Surgical, Surgical Site Infection, Dehiscence of Internal Surgical Wound
- Keywords
- negative pressure wound closure, surgical site infection, cost effectiveness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No chance to enroll sufficient cases. Several coinvestigator centers have never started recruiting.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Borbala HospitalOther government
- Collaborators
- Semmelweis University, Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest, Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár, Institute of Surgery, University of Debrecen, Department of Surgery, University of Szeged, Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest, Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely, Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét, Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen, Department of Surgery, Szent Rókus Kórház, Baja, Department of Surgery, St. Borbala hospital, Tatabanya
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 23 Oct 2018 (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.
Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.
NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.
In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.
Detailed description
The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.
Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.
Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).
A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.
Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50-50% randomisation into interventional (ciNPWT) and control (traditionaltreatment) groups.
| Arm | Type | Receives |
|---|---|---|
| ciNPWT | Experimental | Device: Prophylactic negative pressure wound dressing after laparotomyProphylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation. Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed. |
| Traditional wound dressing | No intervention | –Control group with traditional, dry laparotomy wound dressing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
- Surgical wound type III or IV..
Key exclusion criteria (7 listed)
- Patients not giving informed consent.
- Patients requiring open abdominal wound care.
- Patients with abdominal wall malignancy,
- Patients with peritoneal carcinomatosis,
- Patients who are planned for second look laparotomy within 5 days,
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 |
|---|---|---|
| Prophylactic negative pressure wound dressing after laparotomyFive days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound. | Device | ciNPWT |
Primary outcome
Surgical site infection
Time frame: 30 days
Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)
1 secondary outcome
Full thickness abdominal wall dehiscence, requiring re-operation
Time frame: 30 days
Results and safety
The study was stopped early (reason given: No chance to enroll sufficient cases. Several coinvestigator centers have never started recruiting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Results publication: PubMed 30267040Sahebally SM, McKevitt K, Stephens I, Fitzpatrick F, Deasy J, Burke JP, McNamara D. Negative Pressure Wound Therapy for Closed Laparotomy Incisions in General and Colorectal Surgery: A Systematic Review and Meta-analysis. JAMA Surg. 2018 Nov 1;153(11):e183467. doi: 10.1001/jamasurg.2018.3467. Epub 2018 Nov 21.
- Results publication: PubMed 30047611Curran T, Alvarez D, Pastrana Del Valle J, Cataldo TE, Poylin V, Nagle D. Prophylactic closed-incision negative-pressure wound therapy is associated with decreased surgical site infection in high-risk colorectal surgery laparotomy wounds. Colorectal Dis. 2019 Jan;21(1):110-118. doi: 10.1111/codi.14350. Epub 2018 Aug 20.
- Results publication: PubMed 29718814Gachabayov M, You K, Sullivan R, Bergamaschi R. A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery. Ostomy Wound Manage. 2018 Apr;64(4):22-29.
- Results publication: PubMed 28885895Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.
- Results publication: PubMed 28692475Athanasiou AN, Spartalis M, Spartalis E. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds After Abdominal Operations: What We Really Know? Ann Surg. 2018 Jul;268(1):e19-e20. doi: 10.1097/SLA.0000000000002413. No abstract available.
- Derived from this study: PubMed 40605477Herczeg A, Szijarto A, Fulop A, Varga K, Marton J, Loderer Z, Mohos B, Pancel B, Szendrenyi V, Lazar G, Libor L, Kaposztas Z, Mathe E, Bursics A, Kecskedi B, Sikorszki L, Venczel L, Banky B. Prophylactic Negative Pressure Wound Therapy Reduces Superficial Surgical Site Infection Risk of Emergency Surgery Patients: Results of a Multicenter Randomised Prospective Clinical Trial. Int Wound J. 2025 Jul;22(7):e70718. doi: 10.1111/iwj.70718.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic negative pressure wound dressing after laparotomy in people with Surgical Wound and Wound Dehiscence, Surgical, run by St. Borbala Hospital at 1 site in Hungary.
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 7 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: stopped early, as of the sponsor's last update on 22 Mar 2021. 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 Hungary. 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 was stopped early (reason given: No chance to enroll sufficient cases. Several coinvestigator centers have never started recruiting.). Results are not available in the source record.
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 (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 NCT03716687, 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 22 Mar 2021.