Loading…
PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)
Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence stil...
Saved in:
Published in: | Contemporary clinical trials communications 2024-04, Vol.38, p.101256, Article 101256 |
---|---|
Main Authors: | , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
cited_by | |
---|---|
cites | cdi_FETCH-LOGICAL-c479t-d642290398dc81c80ee9215e8a1d59cac2bba993550e93c75d439d3d62031cb03 |
container_end_page | |
container_issue | |
container_start_page | 101256 |
container_title | Contemporary clinical trials communications |
container_volume | 38 |
creator | Marckmann, Mads Henriksen, Nadia A. Krarup, Peter-Martin Helgstrand, Frederik Vester-Glowinski, Peter Christoffersen, Mette Willaume Jensen, Kristian Kiim |
description | Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence still not provided. This study hypothesizes that this patient group would benefit from ciNPT by reducing wound complications and improving postoperative quality of life.
This is a multicenter Randomized Controlled Trial (RCT) including a total of 110 patients allocated in a 1:1 ratio with one intervention arm and one active control arm receiving ciNPT (i.e., Prevena™) and standard wound dressing, respectively. The primary outcome is the incidence of SSI at 30 days postoperatively and secondary outcomes are 1) pooled incidence of Surgical Site Occurrence (SSO), 2) patient-reported pain and satisfaction with the scar, and 3) hernia-related quality of life.
Patients undergoing elective open incisional hernia repair are fragile with a high risk of wound complication development. This multicenter RCT seeks to deliver the high-quality evidence needed to establish the role ciNPT must play for exactly this group with the aim of reducing SSI incidence and health economic costs, and finally improving quality of life. There are no theoretical or clinical experience of unwanted consequences of this treatment. |
doi_str_mv | 10.1016/j.conctc.2024.101256 |
format | article |
fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_d4b18e8c8c0b4d4daca11dee58665abe</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S2451865424000036</els_id><doaj_id>oai_doaj_org_article_d4b18e8c8c0b4d4daca11dee58665abe</doaj_id><sourcerecordid>2921116730</sourcerecordid><originalsourceid>FETCH-LOGICAL-c479t-d642290398dc81c80ee9215e8a1d59cac2bba993550e93c75d439d3d62031cb03</originalsourceid><addsrcrecordid>eNp9UstuEzEUHSEQrUr_ACEvy2KC7XnZLEBVVaBS1UYtrC3P9U3iaGYcbE-k8CP8Lk6nRO2mK1v2ed2rk2XvGZ0xyupP6xm4ASLMOOXl_olX9avsmJcVy0Vdla-f3I-y0xDWlCZe0STg2-yoEFwKyerj7O_87naz2nUaogUCnQtoiB3ABusGcoNLHe0W8_nd5f396JFEjzr2OMQEIm6DwwGsO7JCP1hNPG609Z_J3LvowHVk4TzRpB-75JGo6InXg3G9_ZPMoreJepZyPJiQEEez-_gue7PQXcDTx_Mk-_Xt8ufFj_z69vvVxfl1DmUjY27qknNJCykMCAaCIkrOKhSamUqCBt62WsqiqijKAprKlIU0hak5LRi0tDjJriZd4_Rabbzttd8pp616eHB-qbRPsTtUpmyZQAECaFua0mjQjBnEStR1pVtMWl8nrc3Y9mj2o3rdPRN9_jPYlVq6rWJU8KZumqRw9qjg3e8RQ1S9DYBdpwd0Y1A8DcdY3RT74OUEBe9C8Lg4-DCq9h1RazV1RO07oqaOJNqHpxkPpP-NSIAvEwDT1rcWvQpgcQA01iPEtBb7ssM_Zg_SNQ</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2921116730</pqid></control><display><type>article</type><title>PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)</title><source>ScienceDirect®</source><source>NCBI_PubMed Central(免费)</source><creator>Marckmann, Mads ; Henriksen, Nadia A. ; Krarup, Peter-Martin ; Helgstrand, Frederik ; Vester-Glowinski, Peter ; Christoffersen, Mette Willaume ; Jensen, Kristian Kiim</creator><creatorcontrib>Marckmann, Mads ; Henriksen, Nadia A. ; Krarup, Peter-Martin ; Helgstrand, Frederik ; Vester-Glowinski, Peter ; Christoffersen, Mette Willaume ; Jensen, Kristian Kiim</creatorcontrib><description>Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence still not provided. This study hypothesizes that this patient group would benefit from ciNPT by reducing wound complications and improving postoperative quality of life.
This is a multicenter Randomized Controlled Trial (RCT) including a total of 110 patients allocated in a 1:1 ratio with one intervention arm and one active control arm receiving ciNPT (i.e., Prevena™) and standard wound dressing, respectively. The primary outcome is the incidence of SSI at 30 days postoperatively and secondary outcomes are 1) pooled incidence of Surgical Site Occurrence (SSO), 2) patient-reported pain and satisfaction with the scar, and 3) hernia-related quality of life.
Patients undergoing elective open incisional hernia repair are fragile with a high risk of wound complication development. This multicenter RCT seeks to deliver the high-quality evidence needed to establish the role ciNPT must play for exactly this group with the aim of reducing SSI incidence and health economic costs, and finally improving quality of life. There are no theoretical or clinical experience of unwanted consequences of this treatment.</description><identifier>ISSN: 2451-8654</identifier><identifier>EISSN: 2451-8654</identifier><identifier>DOI: 10.1016/j.conctc.2024.101256</identifier><identifier>PMID: 38298916</identifier><language>eng</language><publisher>Netherlands: Elsevier Inc</publisher><subject>Closed incision negative pressure therapy (ciNPT) ; Incisional hernia ; Open hernia repair ; Quality-of-life ; Surgical site infection</subject><ispartof>Contemporary clinical trials communications, 2024-04, Vol.38, p.101256, Article 101256</ispartof><rights>2024 The Authors</rights><rights>2024 The Authors.</rights><rights>2024 The Authors 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c479t-d642290398dc81c80ee9215e8a1d59cac2bba993550e93c75d439d3d62031cb03</cites><orcidid>0000-0001-5702-8352 ; 0000-0003-1319-1451 ; 0000-0003-4212-4936 ; 0009-0004-3608-5146</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10827677/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S2451865424000036$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,3535,27903,27904,45759,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38298916$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Marckmann, Mads</creatorcontrib><creatorcontrib>Henriksen, Nadia A.</creatorcontrib><creatorcontrib>Krarup, Peter-Martin</creatorcontrib><creatorcontrib>Helgstrand, Frederik</creatorcontrib><creatorcontrib>Vester-Glowinski, Peter</creatorcontrib><creatorcontrib>Christoffersen, Mette Willaume</creatorcontrib><creatorcontrib>Jensen, Kristian Kiim</creatorcontrib><title>PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)</title><title>Contemporary clinical trials communications</title><addtitle>Contemp Clin Trials Commun</addtitle><description>Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence still not provided. This study hypothesizes that this patient group would benefit from ciNPT by reducing wound complications and improving postoperative quality of life.
This is a multicenter Randomized Controlled Trial (RCT) including a total of 110 patients allocated in a 1:1 ratio with one intervention arm and one active control arm receiving ciNPT (i.e., Prevena™) and standard wound dressing, respectively. The primary outcome is the incidence of SSI at 30 days postoperatively and secondary outcomes are 1) pooled incidence of Surgical Site Occurrence (SSO), 2) patient-reported pain and satisfaction with the scar, and 3) hernia-related quality of life.
Patients undergoing elective open incisional hernia repair are fragile with a high risk of wound complication development. This multicenter RCT seeks to deliver the high-quality evidence needed to establish the role ciNPT must play for exactly this group with the aim of reducing SSI incidence and health economic costs, and finally improving quality of life. There are no theoretical or clinical experience of unwanted consequences of this treatment.</description><subject>Closed incision negative pressure therapy (ciNPT)</subject><subject>Incisional hernia</subject><subject>Open hernia repair</subject><subject>Quality-of-life</subject><subject>Surgical site infection</subject><issn>2451-8654</issn><issn>2451-8654</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNp9UstuEzEUHSEQrUr_ACEvy2KC7XnZLEBVVaBS1UYtrC3P9U3iaGYcbE-k8CP8Lk6nRO2mK1v2ed2rk2XvGZ0xyupP6xm4ASLMOOXl_olX9avsmJcVy0Vdla-f3I-y0xDWlCZe0STg2-yoEFwKyerj7O_87naz2nUaogUCnQtoiB3ABusGcoNLHe0W8_nd5f396JFEjzr2OMQEIm6DwwGsO7JCP1hNPG609Z_J3LvowHVk4TzRpB-75JGo6InXg3G9_ZPMoreJepZyPJiQEEez-_gue7PQXcDTx_Mk-_Xt8ufFj_z69vvVxfl1DmUjY27qknNJCykMCAaCIkrOKhSamUqCBt62WsqiqijKAprKlIU0hak5LRi0tDjJriZd4_Rabbzttd8pp616eHB-qbRPsTtUpmyZQAECaFua0mjQjBnEStR1pVtMWl8nrc3Y9mj2o3rdPRN9_jPYlVq6rWJU8KZumqRw9qjg3e8RQ1S9DYBdpwd0Y1A8DcdY3RT74OUEBe9C8Lg4-DCq9h1RazV1RO07oqaOJNqHpxkPpP-NSIAvEwDT1rcWvQpgcQA01iPEtBb7ssM_Zg_SNQ</recordid><startdate>20240401</startdate><enddate>20240401</enddate><creator>Marckmann, Mads</creator><creator>Henriksen, Nadia A.</creator><creator>Krarup, Peter-Martin</creator><creator>Helgstrand, Frederik</creator><creator>Vester-Glowinski, Peter</creator><creator>Christoffersen, Mette Willaume</creator><creator>Jensen, Kristian Kiim</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-5702-8352</orcidid><orcidid>https://orcid.org/0000-0003-1319-1451</orcidid><orcidid>https://orcid.org/0000-0003-4212-4936</orcidid><orcidid>https://orcid.org/0009-0004-3608-5146</orcidid></search><sort><creationdate>20240401</creationdate><title>PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)</title><author>Marckmann, Mads ; Henriksen, Nadia A. ; Krarup, Peter-Martin ; Helgstrand, Frederik ; Vester-Glowinski, Peter ; Christoffersen, Mette Willaume ; Jensen, Kristian Kiim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-d642290398dc81c80ee9215e8a1d59cac2bba993550e93c75d439d3d62031cb03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Closed incision negative pressure therapy (ciNPT)</topic><topic>Incisional hernia</topic><topic>Open hernia repair</topic><topic>Quality-of-life</topic><topic>Surgical site infection</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Marckmann, Mads</creatorcontrib><creatorcontrib>Henriksen, Nadia A.</creatorcontrib><creatorcontrib>Krarup, Peter-Martin</creatorcontrib><creatorcontrib>Helgstrand, Frederik</creatorcontrib><creatorcontrib>Vester-Glowinski, Peter</creatorcontrib><creatorcontrib>Christoffersen, Mette Willaume</creatorcontrib><creatorcontrib>Jensen, Kristian Kiim</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>Contemporary clinical trials communications</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Marckmann, Mads</au><au>Henriksen, Nadia A.</au><au>Krarup, Peter-Martin</au><au>Helgstrand, Frederik</au><au>Vester-Glowinski, Peter</au><au>Christoffersen, Mette Willaume</au><au>Jensen, Kristian Kiim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study)</atitle><jtitle>Contemporary clinical trials communications</jtitle><addtitle>Contemp Clin Trials Commun</addtitle><date>2024-04-01</date><risdate>2024</risdate><volume>38</volume><spage>101256</spage><pages>101256-</pages><artnum>101256</artnum><issn>2451-8654</issn><eissn>2451-8654</eissn><abstract>Negative Pressure Therapy in closed incisions (ciNPT) after surgery has shown positive effects including reduction of Surgical Site Infection (SSI) incidence. In patients undergoing elective open incisional hernia repair, however, ciNPT is not standard care, perhaps due to high-quality evidence still not provided. This study hypothesizes that this patient group would benefit from ciNPT by reducing wound complications and improving postoperative quality of life.
This is a multicenter Randomized Controlled Trial (RCT) including a total of 110 patients allocated in a 1:1 ratio with one intervention arm and one active control arm receiving ciNPT (i.e., Prevena™) and standard wound dressing, respectively. The primary outcome is the incidence of SSI at 30 days postoperatively and secondary outcomes are 1) pooled incidence of Surgical Site Occurrence (SSO), 2) patient-reported pain and satisfaction with the scar, and 3) hernia-related quality of life.
Patients undergoing elective open incisional hernia repair are fragile with a high risk of wound complication development. This multicenter RCT seeks to deliver the high-quality evidence needed to establish the role ciNPT must play for exactly this group with the aim of reducing SSI incidence and health economic costs, and finally improving quality of life. There are no theoretical or clinical experience of unwanted consequences of this treatment.</abstract><cop>Netherlands</cop><pub>Elsevier Inc</pub><pmid>38298916</pmid><doi>10.1016/j.conctc.2024.101256</doi><orcidid>https://orcid.org/0000-0001-5702-8352</orcidid><orcidid>https://orcid.org/0000-0003-1319-1451</orcidid><orcidid>https://orcid.org/0000-0003-4212-4936</orcidid><orcidid>https://orcid.org/0009-0004-3608-5146</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 2451-8654 |
ispartof | Contemporary clinical trials communications, 2024-04, Vol.38, p.101256, Article 101256 |
issn | 2451-8654 2451-8654 |
language | eng |
recordid | cdi_doaj_primary_oai_doaj_org_article_d4b18e8c8c0b4d4daca11dee58665abe |
source | ScienceDirect®; NCBI_PubMed Central(免费) |
subjects | Closed incision negative pressure therapy (ciNPT) Incisional hernia Open hernia repair Quality-of-life Surgical site infection |
title | PROphylactic closed incision Negative-PRESSure treatment in open incisional hernia repair: Protocol for a multicenter randomized trial (PROPRESS study) |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-24T10%3A06%3A20IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=PROphylactic%20closed%20incision%20Negative-PRESSure%20treatment%20in%20open%20incisional%20hernia%20repair:%20Protocol%20for%20a%20multicenter%20randomized%20trial%20(PROPRESS%20study)&rft.jtitle=Contemporary%20clinical%20trials%20communications&rft.au=Marckmann,%20Mads&rft.date=2024-04-01&rft.volume=38&rft.spage=101256&rft.pages=101256-&rft.artnum=101256&rft.issn=2451-8654&rft.eissn=2451-8654&rft_id=info:doi/10.1016/j.conctc.2024.101256&rft_dat=%3Cproquest_doaj_%3E2921116730%3C/proquest_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c479t-d642290398dc81c80ee9215e8a1d59cac2bba993550e93c75d439d3d62031cb03%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2921116730&rft_id=info:pmid/38298916&rfr_iscdi=true |