Negative pressure wound therapy for the open abdomen (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Negative pressure wound therapy for the open abdomen

1       Provisional recommendations

1.1    Current evidence on the safety and efficacy of negative pressure wound therapy (NPWT) for the open abdomen is inadequate in quality and quantity. There has been concern about the occurrence of intestinal fistulae associated with this procedure but there is currently no evidence about whether NPWT is the cause. Therefore clinicians should make special arrangements for audit of the management of all patients with an open abdominal wound, as recommended below.

1.2    Clinicians managing any patient with an open abdomen (laparostomy) should:

• Inform the clinical governance leads in their Trusts with the aim of ensuring that audit support is available for collecting data for each patient, whether treated by NPWT or by other means, specifically to document the development of intestinal fistulae.
• Use the NICE audit tool to collect data on outcomes for each patient, including those treated by NPWT for the open abdomen (see section 3.1). Anonymised data collected using the audit tool should be submitted to the Review Body for Interventional Procedures [[details to be completed at publication]].
• Whenever possible ensure that patients and their families or carers understand the uncertainty about the safety and efficacy of NPWT and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]

1.3    Negative pressure wound therapyfor the open abdomen should only be carried out by staff with specific training in the procedure.

1.4    NICE encourages further research into the role of NPWT for the open abdomen. This should include a clear description of the patients and indications, documentation of efficacy outcomes such as ease of wound care, healing rates and duration of intensive or high-dependency care, and safety outcomes including development of fistulae. Details of patients involved in research studies should also be included in the audit described in section 1.2. NICE will review the procedure when sufficient audit data and other published evidence are available.

2       The procedure

2.1    Indications and current treatments

2.1.1 NPWT for the open abdomen may be used in the management of patients with an open abdominal wound (laparostomy) where the gut and other intraperitoneal organs are exposed. These patients can be divided into three groups:

a) patients who have had surgery that did not involve the gastrointestinal tract, and in whom delayed primary closure is planned within 1 week (for example, after ‘damage-control’ surgery for trauma or repair of a ruptured abdominal aneurysm)

b) patients who have had gastrointestinal tract surgery for the management of abdominal sepsis associated with severe gastrointestinal disease (including anastomotic dehiscence, visceral perforation, or inflammatory bowel disease) or severe pancreatitis

c) patients who have had abdominal wound dehiscence.

Intestinal fistulae may be present in patients in groups (b) or (c) above, but it is in these two groups that there is uncertainty about a possible causal link between the use of NPWT and the development of fistulae.

2.1.2 Patients in whom delayed primary closure is planned – group (a) above – may be managed using a ‘Bogota bag’ or various types of dressings. For all patients, continued dressings, split-thickness skin grafts, mesh repair, muscle flaps or a combination of these may be used to achieve closure (referred to in some of the published evidence as fascial closure).

2.2    Outline of the procedure

2.2.1 In this procedure a sealed suction system is used to remove exudate and infected material from the abdominal cavity. A membrane is placed over the abdominal contents, a foam sponge dressing is placed over this, and a perforated drainage tube is positioned within the foam sponge. The entire area and surrounding skin are covered with an adhesive transparent membrane and negative pressure is applied via a vacuum pump.   

2.2.2 Negative pressure wound therapy for the open abdomen aims to facilitate nursing care by preventing gross discharge of fluid and to promote healing.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP749overview

2.3    Efficacy

2.3.1 A randomised controlled trial (RCT) of 51 patients who had exploratory laparotomy requiring temporary abdominal closure after damage-control laparotomy, massive visceral oedema or planned re-exploration and who were treated by NPWT or mesh closure reported no significant difference in achievement of delayed fascial closure between treatment groups (31% and 26% of patients, respectively) (absolute figures, significance and follow-up not stated). A case series of 258 patients needing open abdominal management (laparostomy) after general or vascular surgery for re-exploration (n = 142) or trauma (n = 116) and treated by NPWT reported that 88% (226/258) of patients underwent abdominal wound closure (follow-up not stated). Of these, 68% (154/226) had direct fascial closure at a mean of 3.6 days and 32% (72/226) needed skin grafting for closure. A non-randomised controlled trial of 72 patients who required open abdominal management (laparostomy) for abdominal sepsis or abdominal compartment syndrome, and were treated by NPWT or primary abdominal closure, reported complete fascial closure in 70% (26/37) of patients treated by NPWT after a median treatment period of 22.7 days (range 3–122 days).

2.3.2 In a case series of 100 patients who had abdominal wall reconstruction following prior surgery, infection (sepsis) or trauma, mean wound closure time after NPWT was 18 days (range 11–25 days) in patients with full-thickness deficits (loss of all the superficial and musculofascial layers)  and 13 days (range 11–14 days) in patients with partial-thickness deficits (loss of skin and subcutaneous fascia). A non-randomised controlled trial of 109 patients with sepsis after pancreatic necrosectomy reported that median surgical treatment period (time during which repeat laparotomies were needed) was significantly shorter in the NPWT group (mean 16 days; range 9–29 days) than in the group treated with an adhesive foil covering (mean 21 days; range 10–33 days), (p < 0.05). A case series of 29 patients who had laparotomy for intra-abdominal sepsis (n = 20), visceral oedema (n = 5) or increased abdominal pressure (n = 4) reported that the median duration of NPWT before wound closure was 26 days (range 2–68 days).

2.3.3 In the RCT of 51 patients, NPWT failed in 2 patients because evisceration occurred around the device. Their treatment was converted to mesh closure.

2.3.4 The non-randomised controlled trial of 72 patients reported aesthetic appearance at 9 months (evaluated using the 12-point Vancouver scale; lower scores better). Median aesthetic appearance score was 3.7 points (range 2.7–4.4 points) in the NPWT treatment group and 9.1 points (range
8.6–9.7 points) in patients who had laparostomys with primary abdominal closure (significance not stated).

2.3. The Specialist Advisers listed key efficacy outcomes as survival, reduced sepsis, ability to close the abdomen early, reduced need for later plastic or prosthetic abdominal wall replacement, reduced wound size, and patient satisfaction.

2.4    Safety

2.4.1 The RCT of 51 patients treated by NPWT or mesh reported enterocutaneous fistulae in 21% and 5%, respectively (absolute figures not stated), but there was no significant difference between the treatment groups (p = 0.14). A pancreatic fistula was reported in 1 patient treated with mesh. In the non-randomised controlled trial of 72 patients treated by NPWT or primary abdominal closure, a high-output enterocutaneous fistula developed in 1 of 37 (3%) patients treated by NPWT. In the case series of 258 patients, an enterocutaneous fistula developed in 5% (13/258) of patients (12 fistulae occurred after operations that included bowel resection and anastomosis). The case series of 29 patients reported that 20% (6/29) of patients developed an intestinal fistula at a median follow-up of 20 days.

2.4.2 The case series of 258 patients reported development of an intra-abdominal abscess in 3% (9/258) of patients. In the RCT of 51 patients 44% of patients treated by NPWT and 47% of those treated by mesh closure developed an abdominal abscess (absolute numbers not stated). Indications for open abdominal management in these series included trauma and general surgery: therefore, it is not possible to say that the abscesses developed as a result of NPWT.

2.4.3 Bowel obstruction was reported in 1% (3/258) of patients in the case series of 258 patients.

2.4.4 One Specialist Adviser described a series of patients with open abdomens referred from various hospitals in whom fistulae had developed after the application of NPWT, and in whom there were no other obvious predisposing factors. The Specialist Advisers stated that adverse events may relate to technique, including poor application of the foam dressing, and that foam touching the bowel may lead to fistula formation. The Specialist Advisers listed possible adverse events as fistula formation, bowel injury and anastomotic leakage causing catastrophic sepsis.

3       Further information

3.1    This guidance requires that clinicians undertaking the procedure make special arrangements for audit, with submission of data to inform future NICE guidance. NICE has identified relevant audit criteria and is developing an audit tool which will be available when the guidance is published. This tool should be completed and submitted as described in section 1.2 above.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

July 2009

 

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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Management of the open abdomen

Draft audit support

 

Using audit support

This audit has been organised because of concern about the occurrence of intestinal fistulae associated with negative pressure wound therapy (NPWT) for the open abdomen (laparostomy). There is currently no evidence about whether NPWT is the cause and patients with laparostomy are a high risk group in whom there are frequently co-morbidities predisposing them to fistulae formation. Therefore, in order to assess whether there is an excess risk of fistulae formation with NPWT, and identify possible clinical subgroups at particular risk, it is necessary to gather data on all patients with an open abdomen, in whom NPWT is not used as well as those in whom it is used.

Please complete a data sheet for all patients;

• with an open abdomen (laparostomy) where the gut and other intraperitoneal organs are exposed.
• who are an inpatient at any time between XX Nov 2009 - XX June 2011 [[details to be completed at publication]]

Data should be submitted using the web portal XXX or data collection forms should be sent by registered post to XXX where there is no access to the web application. [[details to be completed at publication]]

If you have any enquiries relating to this audit, please contact XXX [[details to be completed at publication]]

Please include details of the person submitting the information, their title and the hospital from which it is sent.

Links with other national priorities

The audit based on this guideline should be considered in conjunction with other relevant national priorities such as:

• [Insert titles and hyperlinks to related NICE audit support, national audits, NSFs and Healthcare Commission requirements] [[details to be completed at publication]]

 

Table 1. Data collection form: Complete one form for each patient or procedure.

Patient identifier:(please leave for completion centrally)	Sex:	Age:	Ethnicity:
	M/F

 

DATA ITEM	Tick/complete box as indicated
Admission details
Admission date	Date:    ____/_____/_____
Discharge date	Date:    ____/_____/_____
Surgery details
Surgical procedure immediately preceding need for open abdominal care	Details:
Date of surgery	Date:    ____/_____/_____
Number of previous abdominal operations on this admission	Number:
Number of intestinal suture lines or anastomoses	Number:
Underlying pathology leading to the abdomen being left open
Trauma without gut injury	Yes	No
Aortic aneurysm repair	Yes	No
Severe pancreatitis	Yes	No
Inflammatory bowel disease e.g.  Crohn’s disease /ulcerative colitis  / other (If yes , please delete as appropriate)	Yes	No
Primary visceral perforation e.g. colon, gallbladder etc. If Yes please specify:	Yes	No
Anastomotic/suture line leakage	Yes	No
Abdominal dehiscence	Yes	No
Other (please specify)	Yes	No
Morbidity score
ASA  score If other score used, please give details	Score:

 

Was NPWT used?	Yes	No
Who made the decision to use NPWT? (please indicate below)
Consultant Surgeon	Yes	No
Other Consultant	Yes	No
Trainee doctor e.g. Specialist Registrar (SpR)	Yes	No
Specialist nurse	Yes	No
Other (please specify)	Yes	No
NPWT details
Date NPWT initiated:	Date:    ____/_____/_____
Date NPWT stopped:	Date:    ____/_____/_____
Was a commercially available NPWT system used?	Yes	No
If yes, please give manufacturer and type of product used
Pressure applied	__________ mmHg
Was an ‘in-house’ locally produced NPWT system?	Yes	No
If yes, please give details of NPWT used i.e. details of the non-adherent sheet placed over viscera, and the type of wall suction etc.
Pressure applied	__________ mmHg
Details of management of the open abdomen if not using NPWT
Bagota bag	Yes	No
Other (please specify)	Yes	No
ITU/ICU/HDU CARE
Was the patient admitted to ITU/ICU/HDU?	Yes	No
Date admitted to ITU/ICU/HDU?	Date:    ____/_____/_____
Length of stay on ITU/ICU/HDU (if applicable)	__________ (days/weeks)

 

Fistulae details
Were there fistulae in the abdominal wound present prior to NPWT?	Yes	No
If yes, please indicate amount	Single	Multiple
If multiple, please indicate how many?	<5 fistulae	>5 fistulae
Give details of origin of fistulae e.g. colon, stomach etc.
Output (per 24 hours)	Low <500ml	High >500 ml
Did the fistula(e) develop whilst NPWT was being used?	Yes	No
If yes, please indicate amount	Single	Multiple
If multiple, please indicate how many?	<5 fistulae	>5 fistulae
Give details of origin of fistula(e) e.g. colon, stomach etc.
Output (per 24 hours)	Low <500ml	High >500 ml
Did the fistula(e) develop after NPWT had been discontinued?	Yes	No
If yes, please indicate amount	Single	Multiple
If multiple, please indicate how many?	<5 fistulae	>5 fistulae
Give details of origin of fistula(e) e.g. colon, stomach etc.
Output (per 24 hours)	Low <500ml	High >500 ml

 

Outcome
Further surgery needed to manage fistula(e)? If yes, please give details:	Yes	No
Need for prolonged (>28 days) Total Parenteral Nutrition? (see HIFNET document from Department of Health) If yes, please give details:	Yes	No
Plastic or prosthetic replacement of the abdominal wall? If yes, please give details:	Yes	No
Permanent wound closure achieved without need for further surgery? If yes, please give details:	Yes	No
Referral to another hospital for management of fistula(e)? If yes, please give details:	Yes	No
Adverse events during NWPT
Systemic complications? If yes, please give details:	Yes	No
Bleeding requiring medical intervention? If yes, please give details:	Yes	No
Death? If yes, please give details:	Yes	No
Other? (please specify) If yes, please give details:	Yes	No

 

Further information

Click here for further information on reporting and monitoring the audit of NICE guidance in your organisation.

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved.

Supporting implementation

A practical guide to implementation, ‘How to put NICE guidance into practice: a guide to implementation for organisations’, is also available on our website (www.nice.org.uk/usingguidance/implementationtools).

The guidance

You can download the guidance documents from www.nice.org.uk/IPXXX

• Interventional procedures guidance – all the recommendations.
• ‘Understanding NICE guidance’ – information for patients and carers.

For printed copies of the ‘Understanding NICE guidance’, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk and quote NXXXX (‘Understanding NICE guidance’). [[details to be completed at publication]]

 

Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.

 

It is the responsibility of consultees to accurately cite academic work in order that they can be validated.