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International Journal of Colorectal Disease
Published in: International Journal of Colorectal Disease 11/2019

01-11-2019 | Laparotomy | CLINICAL STUDY PROTOCOL

Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial

Authors: Noel Edward Donlon, P. A. Boland, M. E. Kelly, K. Schmidt, F. Cooke, P. M. Neary, K. M. Barry, J. V. Reynolds

Published in: International Journal of Colorectal Disease | Issue 11/2019

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Abstract

Background

Superficial surgical site infections are a common post-operative complication. They also place a considerable financial burden on healthcare. The use of prophylactic negative pressure wound therapy has been advocated to reduce wound infection rates. However, there is debate around its routine use. The purpose of this trial is to determine if prophylactic negative pressure wound therapy reduces post-operative wound complications in patients undergoing laparotomy.

Methods/design

This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™). All patients will be over 18 years, who are undergoing an emergency or elective laparotomy. It is intended to enrol a total of 271 patients for the trial.

Discussion

The PROPEL trial is a multi-centre randomised controlled trial of patients undergoing laparotomy. The comparison of standard treatment to two commercially available NPWT will help provide consensus on the routine management of laparotomy wounds.

Trial registration

This study is registered with ClinicalTrials.​gov (NCT number NCT03871023).
Appendix
Available only for authorised users
Literature
1.
Ljungqvist O, Scott M, Fearon KC (2017) Enhanced recovery after surgery: a review. JAMA Surg 152(3):292–298PubMedCrossRef
2.
Gustafsson UO et al (2019) Guidelines for perioperative care in elective colorectal surgery: enhanced recovery after surgery (ERAS). World J Surg 43(3):659–695PubMedCrossRef
3.
Pearson A (2009) Historical and changing epidemiology of healthcare-associated infections. J Hosp Infect 73(4):296–304PubMedCrossRef
4.
5.
Mangram AJ et al (1999) Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control 27(2):97–132 quiz 133–4; discussion 96PubMedCrossRef
6.
McCartan DP et al (2013) Purse-string approximation is superior to primary skin closure following stoma reversal: a systematic review and meta-analysis. Tech Coloproctol 17(4):345–351PubMedCrossRef
7.
O'Leary DP et al (2013) Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial. Surgery 153(3):408–412PubMedCrossRef
8.
Stulberg JJ et al (2010) Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA 303(24):2479–2485PubMedCrossRef
9.
Dellinger EP et al (2005) Hospitals collaborate to decrease surgical site infections. Am J Surg 190(1):9–15PubMedCrossRef
10.
Mujagic E et al (2014) Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials 15:188PubMedPubMedCentralCrossRef
11.
Taylor GD et al (1995) The effect of surgical wound infection on postoperative hospital stay. Can J Surg 38(2):149–153PubMed
12.
Davydov IA et al (1986) Vacuum therapy in the treatment of suppurative lactation mastitis. Vestn Khir Im I I Grek 137(11):66–70PubMed
13.
Kostiuchenok BM et al (1986) Vacuum treatment in the surgical management of suppurative wounds. Vestn Khir Im I I Grek 137(9):18–21PubMed
14.
Morykwas MJ, Argenta LC (1997) Nonsurgical modalities to enhance healing and care of soft tissue wounds. J South Orthop Assoc 6(4):279–288PubMed
15.
Lord AC et al (2015) Successful management of abdominal wound dehiscence using a vacuum assisted closure system combined with mesh-mediated medial traction. Ann R Coll Surg Engl 97(1):e3–e5PubMedPubMedCentralCrossRef
16.
17.
Bertelsen CA et al (2014) Outcome of negative-pressure wound therapy for open abdomen treatment after nontraumatic lower gastrointestinal surgery: analysis of factors affecting delayed fascial closure in 101 patients. World J Surg 38(4):774–781PubMedCrossRef
18.
Gomoll AH, Lin A, Harris MB (2006) Incisional vacuum-assisted closure therapy. J Orthop Trauma 20(10):705–709PubMedCrossRef
19.
Stannard JP et al (2012) Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma 26(1):37–42PubMedCrossRef
20.
Atkins BZ et al (2009) Does negative pressure wound therapy have a role in preventing poststernotomy wound complications? Surg Innov 16(2):140–146PubMedCrossRef
21.
Chadi SA et al (2014) Incisional negative pressure wound therapy decreases the frequency of postoperative perineal surgical site infections: a cohort study. Dis Colon Rectum 57(8):999–1006PubMedCrossRef
22.
Matatov T et al (2013) Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg 57(3):791–795PubMedCrossRef
23.
24.
Mihaljevic AL et al (2014) Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206). Ann Surg 260(5):730–737 discussion 737–9PubMedCrossRef
25.
Diener MK et al (2014) Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial. Lancet 384(9938):142–152PubMedCrossRef
26.
Pinkney TD et al (2013) Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ 347:f4305PubMedPubMedCentralCrossRef
27.
O'Leary DP et al (2017) Prophylactic negative pressure dressing use in closed laparotomy wounds following abdominal operations: a randomized, controlled, open-label trial: the P.I.C.O. trial. Ann Surg 265(6):1082–1086PubMedCrossRef
28.
Murphy PB et al (2018) Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): a randomized controlled trial. Ann Surg 270(1):38-42PubMedCrossRef
29.
30.
Draaijers LJ et al (2004) The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg 113(7):1960–1965 discussion 1966–7PubMedCrossRef
31.
van de Kar AL et al (2005) Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg 116(2):514–522PubMedCrossRef
32.
Sahebally SM et al (2018) Negative pressure wound therapy for closed laparotomy incisions in general and colorectal surgery: a systematic review and meta-analysis. JAMA Surg 153(11):e183467PubMedPubMedCentralCrossRef
33.
Petrica A et al (2009) Accuracy of surgical wound infection definitions—the first step towards surveillance of surgical site infections. TMJ 59(3–4):362–365
34.
Bruce J et al (2001) The quality of measurement of surgical wound infection as the basis for monitoring: a systematic review. J Hosp Infect 49(2):99–108PubMedCrossRef
35.
Reilly JS (1999) The effect of surveillance on surgical wound infection rates. J Tissue Viability 9(2):57–60PubMedCrossRef
36.
Idriss N, Maibach HI (2009) Scar assessment scales: a dermatologic overview. Skin Res Technol 15(1):1–5PubMedCrossRef
37.
Vercelli S et al (2009) How to assess postsurgical scars: a review of outcome measures. Disabil Rehabil 31(25):2055–2063PubMedCrossRef
38.
Glass GE et al (2014) Systematic review of molecular mechanism of action of negative-pressure wound therapy. Br J Surg 101(13):1627–1636PubMedCrossRef
39.
Huang C et al (2014) Effect of negative pressure wound therapy on wound healing. Curr Probl Surg 51(7):301–331PubMedCrossRef
40.
Ma Z et al (2016) Negative pressure wound therapy promotes vessel destabilization and maturation at various stages of wound healing and thus influences wound prognosis. Exp Ther Med 11(4):1307–1317PubMedPubMedCentralCrossRef
41.
Weed T, Ratliff C, Drake DB (2004) Quantifying bacterial bioburden during negative pressure wound therapy: does the wound VAC enhance bacterial clearance? Ann Plast Surg 52(3):276–279 discussion 279–80PubMedCrossRef
42.
Banwell P, Withey S, Holten I (1998) The use of negative pressure to promote healing. Br J Plast Surg 51(1):79PubMedCrossRef
43.
López-Cano M, Armengol-Carrasco M (2013) Use of vacuum-assisted closure in open incisional hernia repair: a novel approach to prevent seroma formation. Hernia 17(1):129–131PubMedCrossRef
44.
Payne C, Edwards D (2014) Application of the single use negative pressure wound therapy device (PICO) on a heterogeneous group of surgical and traumatic wounds. Eplasty 14:e20PubMedPubMedCentral
45.
Heard C et al (2017) Cost-effectiveness analysis alongside a pilot study of prophylactic negative pressure wound therapy. J Tissue Viability 26(1):79–84PubMedCrossRef
46.
Sawyer RG, Evans HL (2018) Surgical site infection-the next frontier in global surgery. Lancet Infect Dis 18(5):477–478PubMedCrossRef
47.
Ramadhar AJ, Abraham F, McAllen C (2018) “Gravity” - a new simple negative pressure wound therapy self-build design for low income countries. J Med Eng Technol 42(7):518–524PubMedCrossRef
Metadata
Title
Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial
Authors
Noel Edward Donlon
P. A. Boland
M. E. Kelly
K. Schmidt
F. Cooke
P. M. Neary
K. M. Barry
J. V. Reynolds
Publication date
01-11-2019
Publisher
Springer Berlin Heidelberg
Published in
International Journal of Colorectal Disease / Issue 11/2019
Print ISSN: 0179-1958
Electronic ISSN: 1432-1262
DOI
https://doi.org/10.1007/s00384-019-03398-9

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