Table 3 Characteristics of included studies
Study | Study design | N participants randomised | Duration of active treatment (intervention group) | Study duration (including length of follow-up) | Setting | Location and study period | Relevant outcomes | Indication/wound type |
|---|---|---|---|---|---|---|---|---|
RCT Blinding not specified Single centre | 20 | Not specified | Until complete epithelization of the skin | Inpatient with outpatient continuatiOn | Sweden February 2007–April 2012 | Mortality Wound closure Adverse events Amputation Hospital stay and readmission | Acute open wounds Deep peri-vascular groyne infections (Szilagyi grade III) | |
RCT Blinding not specified Single centre | 90 | Generally 10–14 days | 1 month | Inpatient | Iran February 2013–March 2015 | Wound closure Adverse events | Acute open wounds Open fracture wound type IIIb based on Gustilo-Anderson classification | |
RCT Outcome-assessor blinded Single centre | 12 | According to the requirements of the nursing staff | 6 months | Inpatient, nursing home and patient’s home | UK September 2008–August 2009 | Mortality Wound closure Adverse events Pain | Chronic open wounds Grade III/V pressure ulcers according to the European Pressure Ulcer Advisory Panel Grading System | |
Banasiewicz et al. (2013) [72] | RCT Blinding not Specified Single centre | 19 | Not specified | Until the wounds healed to restore normal activity | Outpatient | Poland 2012 | Pain Physical function | Acute open wounds Pilonidal sinus (primary/recurrent) |
Bee et al. (2008) [73] | RCT Blinding not Specified Single centre | 51 | maximum 9 days | Not specified | Inpatient | USA April 2003–July 2007 | Mortality Adverse events | Acute open wounds Temporary abdominal closure after damage control laparotomy, massive visceral oedema and planned reexploration |
RCT Unblinded Single centre | 49 | 14 days | 6 months after wound closure | Outpatient | Netherlands October 2009–May 2012 | Wound closure Adverse events Pain Physical function | Acute open wounds Symptomatic pilonidal sinus with or without a previous abscess of the sinus | |
Braakenburg et al. (2006) [76] | RCT Blinding not Specified Single centre | 64 | Not specified | Until 80 days | Inpatient | Netherlands March 2002–May 2004 | Mortality Wound closure Adverse events Amputation | Acute, subacute and chronic wounds Any type of wound |
RCT Unblinded Multicentre (20 centres) | 62 | Until wound healing (maximum 12 weeks) | 12 weeks | Inpatient, at home, medical practice and/or others | Canada and UKMarch 2012–October 2014 | wound closure Adverse events pain Hospital stay and readmission | Subacute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer or other chronic) suitable for treatment with NPWT | |
Chiang et al. (2017) [83] | RCT Unblinded Single centre | 36 | Not specified | 12 months | Inpatient | New ZealandMarch 2010–June 2011 | Adverse events | Acute open wounds Patients with high risk vascular foot wounds |
RCT Unblinded Single centre | 75 | Not specified | Until discharge from hospital | Inpatient | Columbia June 2011–April 2013 | Mortality | Acute open wounds Traumatic open abdomen and open abdomen of a medical cause | |
Dalla Paola et al. (2010) S-II [86] | RCT Blinding not specified Single centre | 130 | Until wound healing or surgical wound closure | 6 months | Inpatient | Italy July 2007–July 2008 | Wound closure Adverse events amputation | Chronic open wounds Diabetic foot wounds |
RCT Unblinded Single centre | 24 | Not specified | Maximum 6 weeks | Inpatient | Netherlands March 2003–March 2005 | Adverse events | Chronic open wounds Difficult-to-heal surgical wounds or paraplegic and tetraplegic patients with pressure ulcers grade IV according to the European Pressure Ulcer Advisory Panel grading system | |
RCT outcome-assessor blinded Multicentre (40 centresb) | 368 | Until wound healing or surgical wound closure (maximum 16 weeks) | 6 months | In- and outpatient | Germany December 2011–February 2015 | Mortality Wound closure Adverse events Amputation Pain | Chronic open wounds Diabetic foot lesions of stadium 2 to 4 according to the Wagner classification | |
Gupta et al. (2013) [96] | RCT blinding not Specified single centre | 30 | Not specified | Not specified | Inpatient | India Study period not specified | Wound closure Adverse events Hospital stay and readmission | Acute open wounds Open musculoskeletal injuries in extremities that required coverage procedures |
Hu et al. (2009) [97] | RCT blinding not specified Single centre | 67 | Until complete wound healing | Until complete wound healing | Inpatient | China September 2005–November 2008 | Wound closure Adverse events Amputation | Chronic open wounds Complex or refractory type lesions |
Huang et al. (2006) [98] | RCT blinding not specified Single centre | 24 | Until wound closure | until natural surgery wound closure | inpatient | Taiwan 2004 | Mortality Amputation Hospital stay and readmission | Acute open wounds Upper or lower limb of acute necrotizing fasciitis |
Jayakumar et al. (2013) [99] | RCT Blinding not specified Single centre | 40 | Not specified | Not specified | Inpatient | India study period not specified | Wound closure Adverse events Hospital stay and readmission | Acute open wounds Type IIIA and Type IIIB open fracture both bones of leg |
Kakagia et al. (2014) [100] | RCT Blinding not specified Single centre | 50 (82 wounds) | Not specified | Average 21 months (range 5–36 months) | Inpatient | Greece June 2006–May 2011 | Wound closure Adverse events | Acute open wounds Leg fasciotomies due to fractures and/or soft tissue injuries |
Karatepe et al. (2011) [101] | RCT Blinding not specified Single centre | 67 | Not specified | Mean 4 months (range 2–8 months) | Inpatient | Turkey May 2007–December 2008 | Wound closure | Chronic open wounds Biabetic foot ulcers |
Leclercq et al. (2016) [102] | RCT Unblinded Single centre | 46 | 5 days | 3 months | Inpatient | France October 2010–May 2014 | Wound closure | Surgically covered wounds Autologous grafting on chronic leg ulcers |
Liao et al. (2012) [103] | RCT Blinding not specified Single centre | 60 | 7–10 days | Average 24 months (range 12–36 months) | Inpatient | China March 2005–June 2010 | Adverse events Hospital stay and readmission | Acute open wounds Amputation wounds for limbs open fractures |
Llanos et al. (2006) [104] | RCT Outcome-assessor blinded Single centre | 60 | 4 days | 7–23 days | Inpatient | Chile May 2003–October 2004 | Wound closure Adverse events Hospital stay and readmission | Acute open wounds Acute traumatic injuries and skin loss which hindered primary closure |
Mody et al. (2008) [105] | RCT Outcome-assessor blinded Single centre | 55 | Until discharge from hospital | Average 26 days ± 18 days (intervention group) Average 33 days ± 37 days (control group) | In- and outpatient | India Study period not specified | Adverse events Amputation Pain | Acute and chronic open wounds Acute or chronic extremity sacral or abdominal wound that could not be treated with primary closure |
Mohsin et al. (2017) [106] | RCT Outcome-assessor blinded Single centre | 100 | 4 days | Until discharge from hospital | Inpatient | India January 2013–December 2015 | Adverse events | Surgically covered wounds |
Moisidis et al. (2004) [107] | RCT Outcome assessor blinded Single centre | 22 (44 half wounds) | 5 days | 2 weeks | Inpatient | Australia July 2001–July 2002 | wound closure Adverse events | acute or chronic open wounds Split-thickness skin graft on acute, subacute or chronic wounds |
RCT Blinding not specified Single centre | 54 | Until surgery wound closure | Until 1 month | Inpatient | Netherlands July 1998–October 2002 | Mortality Wound closure Adverse events | Acute or chronic open wounds Full-thickness wounds | |
Nain et al. (2011) [111] | RCT Blinding not specified Single centre | 30 | Until wound closure (maximum 56 days) | Maximum 8 weeks | Inpatient | India Study period not specified | Wound closure | Chronic open woundsDiabetic foot ulcers |
Novinščak et al. (2010) [112] | RCT 3 trial arms Blinding not specified Single centre | 27c | Not specified | 2 months | Inpatient | Croatia Study period not specified | Wound closure | Chronic open wounds Complicated diabetic ulcer (Wagner 2–5) |
Perez et al. (2010) [113] | RCT Unblinded Single centre | 49 | Not specified | Until 30 days after wound healing | Inpatient | Haiti January 2007–June 2007 | Wound closureAdverse events | Acute and chronic open wounds Fasciitis of leg or forearm, Fournier gangrene, abdominal wound, cervical wound, inguinal hernia repair, trauma to extremities, venous leg ulcer |
Rencüzoğulları et al. (2015) [114] | RCT Blinding not specified Single centre | 40 | Not specified | Not specifiedd | Inpatient | Turkey February 2007–September 2010 | mortality Adverse events Hospital stay and readmission | Acute open wounds Open abdomen/decompressive laparotomy as part of the management of abdominal compartment syndrome |
Saaiq et al. (2010) [115] | RCT Patients blinded Single centre | 100 | 10 days | Until wound healing | Inpatient | Pakistan October 2007–December 2009 | Mortality Wound closure Adverse events Hospital stay and readmission | Acute open wounds Acute traumatic wounds most frequently located on the lower limb, upper limb, trunk and scalp |
Shen et al. (2013) [116] | RCT Blinding not specified Single centre | 307 | 6 days | Not specifiede | Inpatient | China August 2009–May 2012 | Wound closure | Acute open wounds Superficial partial thickness scald in children, shallow second degree burns mainly being located on the thorax, abdomen and limbs |
Sibin et al. (2017) [117] | RCT Blinding not specified Single centre | 30 | Not specified | Not specified | Inpatient | IndiaJanuary 2015–July 2015 | Wound closure Adverse events Hospital stay and readmission | Scute open wounds Gustilo type IIIA or IIIB open tibia fractures |
Sinha et al. (2013) [118] | RCT Outcome assessor blinded Single centre | 30 | Not specified | Not specifiedf | Inpatient | India 2011–2012 | Adverse events | Acute open wounds Open musculoskeletal injuries in extremities according to Gustilo Anderson classification grade II, IIIA, IIIB and IIIC |
RCT Outcome assessor blinded Multicentre (3 centres) | 40 | Not specified | 3 months | In- and Outpatient | UK November 2015–September 2016 | Wound closure Adverse events Amputation Pain Hospital stay and readmission Health-related quality of life | Acute open wounds Surgical wounds on the foot, abdomen, leg, breast, groyne, buttocks or perianal area | |
RCT 4 trial Arms Unblinded Multicentre (3 centres) | 86 | Not specified | 12 months | Inpatient | Netherlands October 2007–February 2010 | Adverse events Pain Hospital stay and readmission | Acute open wounds Deep dermal or full-thickness burns of arm, leg or trunk requiring skin transplantation | |
RCT Outcome-assessor blinded Multicentre (25 centres) | 263g | Until surgery wound closure or wound healing with secondary intention (maximum 84 days) | Maximum 12 months | In- and outpatient | Canada and USA August 2001–October 2006 | Mortality Adverse events | Chronic open wounds Stage III and IV pressure ulcers according to the National Pressure Advisory Panel (NPUAP) staging system located on the trunk or trochanter region | |
RCT Outcome-assessor blinded Multicentre (29 centres) | 208 | Until wound healing with secondary intention (maximum 112 days) | Maximum 12 months | Inpatienth | USA January 2002–July 2005 | Adverse events | Chronic open wounds Venous stasis ulcers | |
RCT Outcome-assessor blinded Multicentre | 12 | Not specified | 90 days | Not specified | USA October 2001–July 2004 | Wound closure Adverse events | Shronic open wounds Split thickness skin graft closure of venous stasis ulcers | |
RCT Unblinded Single centre | 58 (62 wounds) | Until surgery wound closure | Average 28 months (range 14–67 months) | Inpatient | USA June 2001–August 2006 | Wound closure Adverse events Amputation Hospital stay and readmission | Acute open wounds Severe open fractures including type II fractures, type IIIA fractures that were either heavily contaminated or had a remarkably severe soft tissue injury, and all type IIIB or IIIC fractures according to the classification of Gustilo and Anderson | |
RCT Outcome assessor blinded Multicentre (19 centres) | 164i | Until wound closure (maximum 112 days) | Maximum 13 monthsj | Inpatienth | USA August 2002–November 2005 | Mortality Wound closure Adverse events Hospital stay and readmission | Chronic open wounds Diabetic foot amputation wound up to the transmetatarsal region of the foot | |
RCT Unblinded Multicentre (29 centres) | 335 | Until wound closure (maximum 112 days) | Maximum 12 months | Inpatienth | Canada and USA August 2002–August 2005 | Mortality Wound closure Adverse events | Chronic open wounds Diabetic foot ulcer equivalent to Stage 2 or greater as defined by Wagner’s Scale | |
RCT Outcome assessor blinded Multicentre (14 centres) | 54 | Until surgery wound closure or wound healing with secondary intention (maximum 84 days) | Maximum 6 months | Inpatienth | Canada and USA October 2002–July 2005 | Mortality Wound closure Adverse events | Acute open wounds Open chest wounds | |
RCT Outcome assessor blinded Multicentre (19 centres) | 134 | Until surgery wound closure or wound healing with secondary intention (maximum 84 days) | Maximum 6 months | Inpatienth | Canada, Mexico and USA June 2002–October 2004 | Mortality Wound closure Adverse events | Acute open wounds Open abdominal wounds | |
Virani et al. (2016) [154] | RCT Blinding not specified Single centre | 93 | Until sufficient granulation tissue is present or approximation of the wound margins | Average 23 weeks ±6 weeks | Inpatient | India Study period not specified | Wound closure Adverse events | Acute open wounds Open diaphyseal tibial fractures, the majority of which were Gustilo Anderson Grade II and Grade IIIA fractures with heavy contamination and severe soft tissue and bony injury along with all Grade IIIB and Grade IIIC fractures |
RCT Blinding not specified Multicentre (2 centres) | 60 | Maximum 4 days | 12 months | Inpatient | Netherlands May 2001–May 2003 | Mortality Wound closure Adverse events Pain Hospital stay and readmission | Chronic open wounds Chronic venous, combined venous and arterial, or microangiopathic (arteriolosclerotic) leg ulcers of > 6 months’ duration | |
RCT Outcome assessor blinded Multicentre (24 centres) | 460k | Until wound closure or surgical covering | 12 months | Inpatient | UK 07/2012–2012/2015 | Mortality Wound closure Adverse events Amputation Pain Health-related quality of life Physical function | Acute open wounds Severe open fracture of the lower limb. Wounds were graded as a Gustilo and Anderson II or III | |
Xu et al. (2015) [162] | RCT Blinding not specified Single centre | 40 | 3–5 days | Not specifiedl | Inpatient | China 09/2013–2009/2014 | Mortality Wound closure Adverse events Hospital stay and readmission | Acute open wounds Necrotizing fasciitis in the inguinal region or genital area |