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Study flow diagram: review update.
Figures and Tables -
Figure 1

Study flow diagram: review update.

Summary of findings for the main comparison. Saline irrigation with or without prior infiltration of hyaluronidase vs standard wound care for management of extravasation injury in neonates

Saline irrigation with or without prior infiltration of hyaluronidase vs standard wound care for management of extravasation injury in neonates

Patient or population: neonates requiring management of extravasation injury
Setting: neonatal intensive care units
Intervention: saline irrigation with or without prior infiltration of hyaluronidase
Comparison: standard wound care

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with standard wound care

Risk with saline irrigation with or without prior infiltration of hyaluronidase

Complete wound healing after saline irrigation with or without prior hyaluronidase infiltration (wound healing): clinical assessment

Study population

Not estimable

237
(10 observational studies)

⊕⊝⊝⊝
Very low

Pooled data for 237 neonates from 10 case report studies who underwent saline irrigation. Three neonates received further surgical intervention. For 234 neonates, complete wound healing was reported

0 per 1000

0 per 1000
(0 to 0)

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and relative effect of the intervention (and its 95% CI)

CI: confidence interval; OR: odds ratio; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

All 10 studies analysed in GRADE pro GDT are case reports, and the intervention methods mentioned are highly variable. In view of this, "relative effect (95% CI)" and "absolute effect (95% CI)" were not derived.

Figures and Tables -
Summary of findings for the main comparison. Saline irrigation with or without prior infiltration of hyaluronidase vs standard wound care for management of extravasation injury in neonates
Table 1. Summary of excluded studies ‐ study design, population, intervention, and outcome

Study

Type of study

Number of neonates

Extravasation

Intervention

Outcome

Casanova 2001

Case series

14 neonates

Dopamine ‐ 9

Caffeine ‐ 2

Calcium ‐ 2

Beta blocker ‐ 1

Hyaluronidase infiltration and aspiration ‐ 12

Saline irrigation and aspiration ‐ 1

Hyaluronidase infiltration alone ‐ 1

3 cases developed skin necrosis but healed spontaneously

Chen Y Y 1996

Case report

1 neonate

Total parenteral nutrition (TPN)

Infiltration with hyaluronidase with saline irrigation

Healing in 3 days

Chowdhury 2004

Retrospective review of 31 cases

31 neonates had 36 extravasations

TPN ‐ 13

Medications ‐ 10

Blood products ‐ 6

Crystalloids ‐ 5

Contrast ‐ 2

Hyaluronidase infiltration and saline irrigation used for 24 extravasation injuries

No surgical graft required

Davies 1994

Case report

2 preterm neonate less than 29 weeks gestation

TPN

Hyaluronidase infiltration and saline irrigation

Minimal or no scarring, no functional sequelae

Gault 1993

Retrospective review of 96 cases

Total 96 cases referred to a tertiary plastic surgical unit

(age range ‐ preterm neonate to 72 years ‐ exact distribution not mentioned)

44 early referrals, i.e. within 24 hours

52 late referral, i.e. after 24 hours

TPN

Inotrope

Ca

KCl

Bicarbonate

Dextrose: 10%‐20%

Chemotherapeutics

Contrast

Antibiotics

(exact numbers not mentioned)

Early referral group: 44 (saline irrigation alone ‐ 37, liposuction and saline irrigation ‐ 6, liposuction alone ‐ 1)

Late referral group: wound and surgical management

Early referral group:

39 (88.5%) no soft tissue damage, 5 (11.5%) minor skin blistering

Late referral group: 8 (15%) healed without tissue necrosis, 17 (33%) minor skin sloughing, 27 (52%) extensive damage to tissues ‐ 3 amputations

Harris 2001

Retrospective review

56 neonates

TPN

Inotrope

Calcium

Potassium chloride

Sodium bicarbonate

High concentration of dextrose

(exact numbers not mentioned)

Saline irrigation alone

No skin loss. None required reconstructive surgery

Kostogloudis 2015

Case report

34 neonates

TPN ‐ 28

10% dextrose ‐ 4

Second‐generation cephalosporin ‐ 2

Saline irrigation followed by topical application of paraffin‐impregnated gauze and povidone‐iodine‐soaked gauze dressing

In 21 infants, no signs of soft tissue damage by 24 hours of treatment

Minor findings still present for a few days in 7 patents after treatment

Ischaemic signs present in 6 patients subsided within 25 days

Kuensting 2010

Case report

1 neonate

Antibiotics

Infiltration with recombinant human hyaluronidase (rHuPH20)

Wound healed completely by 8 days

Martin 1994

Case report

1 neonate

Dobutamine, adrenaline, 8.4% sodium bicarbonate, 10% calcium gluconate

Infiltration of hyaluronidase followed by liposuction and saline irrigation

No signs of soft tissue damage at 2 weeks

Siu 2007 

Case report

1 neonate

TPN

Hyaluronidase infiltration and saline irrigation

Healed fully by 5 days

Figures and Tables -
Table 1. Summary of excluded studies ‐ study design, population, intervention, and outcome
Table 2. Summary of excluded studies ‐ stage of extravasation and intervention and its outcome

Study

Stage of extravasation

Intervention

Outcome

Reason for exclusion

Casanova 2001

Skin necrosis (stage 3): n = 3

Swelling, oedema, discolouration (stage 1‐2): n = 11

Hyaluronidase and aspiration ‐ 12 cases

Hyaluronidase infiltration alone ‐ 1

Saline irrigation and aspiration ‐ 1

Treatment allocation not specified by stage of injury

No sequelae

Neither a randomised nor a quasi‐randomised study

Chen Y Y 1996

Swelling, erythema, and induration (stage 3): n = 1

Hyaluronidase and saline irrigation

No sequelae

Neither a randomised nor a quasi‐randomised study

Chowdhury 2004

Erythema and oedema (stage 1‐2): n = 12

Skin necrosis (stage 3): n = 24

Stage 1‐2 ‐ standard wound management

Stage 3 ‐ hyaluronidase and saline irrigation

No sequelae

No sequelae

Neither a randomised nor a quasi‐randomised study

Davies 1994

Skin necrosis (stage 3): n = 2

Hyaluronidase and saline irrigation

Minimal scarring, no sequelae

Neither a randomised nor a quasi‐randomised study

Gault 1993

Skin necrosis (stage 3):

Early referral: n = 44

Delayed referral (stage 3‐4): n = 52

Stage 3:

Saline irrigation alone: n = 37

Liposuction and saline irrigation: n = 6

Liposuction alone: n = 1

Stage 3‐4:

Wound debridement and surgical flap

No sequelae

8 (15%) healed without tissue necrosis, 17 (33%) minor skin sloughing, 27 (52%) extensive damage to tissues ‐ 3 amputations

Neither a randomised nor a quasi‐randomised study

Harris 2001

Exact stage of extravasation injury not specified: n = 56

Saline irrigation

No sequelae

Neither a randomised nor a quasi‐randomised study

Kostogloudis 2015

Stage 3 and stage 4 extravasation

Saline irrigation within 30 minutes of extravasation injury

None of the wounds needed secondary skin coverage procedures

Neither a randomised nor a quasi‐randomised study

Kuensting 2010

Discolouration, oedema, cool, pulses not palpable (stage 4): n = 1

Infiltration with recombinant human hyaluronidase (rHuPH20)

No sequelae

Neither a randomised nor a quasi‐randomised study

Martin 1994

Oedema, pallor, cold, and no capillary filling

Infiltration with hyaluronidase, liposuction, and saline irrigation

No sequelae

Neither a randomised nor a quasi‐randomised study

Siu 2007

Skin necrosis (stage 3): n = 1

Hyaluronidase and saline irrigation

No sequelae

Neither a randomised nor a quasi‐randomised study

Figures and Tables -
Table 2. Summary of excluded studies ‐ stage of extravasation and intervention and its outcome