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Subcutaneous closure versus no subcutaneous closure after non-caesarean surgical procedures

  1. Kurinchi Selvan Gurusamy1,*,
  2. Clare D Toon2,
  3. Brian R Davidson1

Editorial Group: Cochrane Wounds Group

Published Online: 21 JAN 2014

Assessed as up-to-date: 29 AUG 2013

DOI: 10.1002/14651858.CD010425.pub2


How to Cite

Gurusamy KS, Toon CD, Davidson BR. Subcutaneous closure versus no subcutaneous closure after non-caesarean surgical procedures. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD010425. DOI: 10.1002/14651858.CD010425.pub2.

Author Information

  1. 1

    Royal Free Campus, UCL Medical School, Department of Surgery, London, UK

  2. 2

    West Sussex County Council, Public Health, Chichester, West Sussex, UK

*Kurinchi Selvan Gurusamy, Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. kurinchi2k@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 21 JAN 2014

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Characteristics of included studies [ordered by study ID]
Cardosi 2006

MethodsRandomised clinical trial


ParticipantsCountry: USA
Number randomised: 155
Post-randomisation drop-outs: not stated
Revised sample size: 155
Average age: 57 years
Females: 155 (100%)
Inclusion criteria: women having elective gynaecological pelvic surgery through a vertical midline incision with a subcutaneous thickness of 3 cm or more
Exclusion criteria: women unable to provide informed consent; hospitalised > 24 h preoperatively; having laparotomy after unsuccessful laparoscopy or vaginal surgery


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 78): subcutaneous closure
Group 2 (n = 77): no subcutaneous closure

We excluded a third group (n = 67) who were randomised to subcutaneous drain

Details of surgery including location and contamination: pelvic surgery for various benign and malignant conditions (clean and clean-contaminated)
Details of suture material: polyglactin 2-0
Continuous or interrupted closure of subcutaneous tissue: continuous

Follow-up: 6 weeks after surgery


OutcomesWound complications and hospital stay


NotesWe attempted to contact the trial authors in February 2013

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available

Allocation concealment (selection bias)Unclear riskComment: this information was not available

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: this was a 3-armed trial, 2 arms of which were eligible for inclusion in this review. There were 3 post-randomisation drop-outs: 1 participant received 48 h of preoperative antibiotics for a pelvic abscess; 1 had postoperative fascial dehiscence requiring reoperation; and 1 had to return to the operating room to control pelvic bleeding. The groups to which these post-randomisation drop-outs belonged were not reported. All three participants could have belonged to the excluded group or all the three participants could have belonged to the two included groups. Since this information was not clear, we have classified this as unclear

Selective reporting (reporting bias)High riskComment: the trial protocol was not available and the trial did not report all the primary outcomes of this review

el Gamel 1994

MethodsRandomised clinical trial


ParticipantsCountry: UK, USA
Number randomised: 200
Post-randomisation drop-outs: not stated
Revised sample size: 200
Average age: not stated
Male: female ratio: 140 (70%): 60 (30%)
Inclusion criteria: people requiring saphenous vein graft excision for coronary artery bypass graft (only people in whom the excision was performed in the thighs were included in this review since the people requiring saphenous vein graft excision from the legs were randomised separately in a different trial which was excluded (el Gamel 1994a)


InterventionsParticipants randomly assigned to 2 groups

Group 1 (n = 100): subcutaneous closure
Group 2 (n = 100): no subcutaneous closure

Details of surgery including location and contamination: saphenous vein graft excision (clean)
Details of suture material: Vicryl 2-0
Continuous or interrupted closure of subcutaneous tissue: not stated

Follow-up: 4-6 weeks after surgery (outpatient review)


OutcomesWound infection


NotesWe attempted to contact the trial authors in February 2013

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available

Allocation concealment (selection bias)Unclear riskComment: this information was not available

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: this information was not available

Selective reporting (reporting bias)High riskComment: the trial protocol was not available and the trial did not report all the primary outcomes of this review

Hussain 1990

MethodsRandomised clinical trial


ParticipantsCountry: Saudi Arabia
Number randomised: 200
Post-randomisation drop-outs: not stated
Revised sample size: 200
Average age: 37 years
Male: female ratio: 30 (15%): 170 (85%)
Inclusion criteria: people having open cholecystectomy for chronic cholecystitis
Exclusion criteria: chronic obstructive airway disease; people requiring choledochotomy (incision on the common bile duct)


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 100): subcutaneous closure
Group 2 (n = 100): no subcutaneous closure

Details of surgery including location and contamination: cholecystectomy for chronic cholecystitis (clean-contaminated)
Details of suture material: polyglactin 2
Continuous or interrupted closure of subcutaneous tissue: interrupted

Follow-up: until hospital discharge


OutcomesWound infection and hospital stay


NotesWe attempted to contact the trial authors in February 2013

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available

Allocation concealment (selection bias)Unclear riskQuote: " . . . randomized by sealed envelopes into two groups"
Comment: further details were not available

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: this information was not available

Selective reporting (reporting bias)High riskComment: the trial protocol was not available and the trial did not report all the primary outcomes of this review

Kong 1993

MethodsRandomised clinical trial


ParticipantsCountry: UK
Number randomised: 50
Post-randomisation drop-outs: not stated
Revised sample size: 50
Average age: 72 years
Male: female ratio: 11 (22%): 39 (78%)
Inclusion criteria: people having hip operation (hemiarthroplasty or hip replacement)
Exclusion criteria: people with previous surgery to the same side


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 25): subcutaneous closure
Group 2 (n = 25): no subcutaneous closure

Details of surgery including location and contamination: hip operations (clean)
Details of suture material: Vicryl (thickness not stated)
Continuous or interrupted closure of subcutaneous tissue: interrupted

Follow-up: 8 days after surgery


OutcomesThis trial reported none of the outcomes of interest for this review


NotesWe attempted to contact the trial authors in February 2013

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available

Allocation concealment (selection bias)Unclear riskComment: this information was not available

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: this information was not available

Selective reporting (reporting bias)High riskComment: the trial protocol was not available, and this trial reported none of the primary outcomes of this review

Kore 2000

MethodsRandomised clinical trial


ParticipantsCountry: India
Number randomised: 60
Post-randomisation drop-outs: not stated
Revised sample size: 60
Average age: 45 years
Females: 60 (100%)
Inclusion criteria: women undergoing abdominal hysterectomy with at least 2.5 cm of subcutaneous fat


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 30): subcutaneous closure
Group 2 (n = 30): no subcutaneous closure

Details of surgery including location and contamination: abdominal hysterectomy (clean)
Details of suture material: polyglycolic acid 2-0
Continuous or interrupted closure of subcutaneous tissue: continuous

Follow-up: 7 days after surgery


OutcomesWound complications


NotesWe attempted to contact the trial authors in February 2013

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available

Allocation concealment (selection bias)Unclear riskComment: this information was not available

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: this information was not available

Selective reporting (reporting bias)High riskComment: the trial protocol was not available and the trial did not report all the primary outcomes of this review

Paral 2007

MethodsRandomised clinical trial


ParticipantsCountry: Czech Republic
Number randomised: 441
Post-randomisation drop-outs: 26 (5.9%)
Revised sample size: 415
Average age: 55 years
Male: female ratio: 274 (66%): 141 (34%)
Inclusion criteria: people requiring elective abdominal surgery


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 210): subcutaneous closure
Group 2 (n = 205): no subcutaneous closure

Details of surgery including location and contamination: elective abdominal surgery (clean and clean-contaminated)

Details of suture material: polyglactin 2-0
Continuous or interrupted closure of subcutaneous tissue: interrupted

Follow-up: 30 days after surgery


OutcomesWound infection: the number of participants who developed wound infection within 30 days was not reported - instead the authors presented the participants who had wound infection on different post-operative days


NotesWe attempted to contact the authors in February 2013
Reasons for post-randomisation drop-outs:

Clean wounds: did not receive intervention (3 in each group) and lost to follow-up (6 in intervention group, 5 in control group)

Clean contaminated wounds: did not receive intervention (1 in intervention group, 4 in control group) and lost to follow-up (1 in intervention group, 3 in control group)

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Randomization was accomplished using a computer program (permutation of blocks by generation of pseudo-random numbers with a rectangular distribution) in order to obtain homogeneity of groups"

Allocation concealment (selection bias)Low riskQuote: "The envelope method was used to decide which patients would undergo suturing of subcutaneous fat. Numbered envelopes contained the sealed information ‘Suture Yes’ or ‘Suture No’. The envelope was unsealed by the operating surgeon in the operation theater just before surgery"

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
High riskComment: there were post-randomisation drop-outs and it is likely that these drop-outs would have had a clinically significant effect on the outcomes

Selective reporting (reporting bias)High riskComment: the trial protocol was not available, and this trial reported none of the primary outcomes of this review

Tamelis 2005

MethodsRandomised clinical trial


ParticipantsCountry: Lithuania
Number randomised: 130
Post-randomisation drop-outs: 9 (6.9%)
Revised sample size: 121
Average age: not stated
Male: female ratio: not stated
Inclusion criteria: people having colorectal surgery through a midline incision


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 66): subcutaneous closure (n = 61 after post-randomisation drop-out)
Group 2 (n = 64): no subcutaneous closure (n = 60 after post-randomisation drop-out)

Details of surgery including location and contamination: colorectal operations (contaminated or dirty)
Details of suture material: Maxon 3-0
Continuous or interrupted closure of subcutaneous tissue: not stated

Follow-up: 2 weeks after surgery


OutcomesWound infection


NotesWe contacted the trial authors in February 2013; the trial authors replied in March 2013

Reason for post-randomisation drop-out: died (2 in intervention group, 1 in control group); eventration (abnormal elevation of the diaphragm) (2 in each group); relaparotomy (1 in each group)

Source of funding: Surgery department (author replies)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The sequence was generated using computer (author replies)"

Allocation concealment (selection bias)Low riskQuote: "The identity of the trial arm was kept in a sequentially numbered, opaque, sealed envelopes (author replies)"

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "Our study was performed in double-blind fashion. It was performed by 2 investigators. The identity of the trial arm was kept in a sequentially numbered, opaque, sealed envelopes. The first investigator made randomisation of the patients randomly selecting envelope and opening it before operation. Neither second investigator (outcome assessor) nor the patient knew about method of wound closure - with subcutaneous suture or without (author replies)"
Comment: the surgeon was aware of the randomisation prior to operation.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Our study was performed in double-blind fashion. It was performed by 2 investigators. The identity of the trial arm was kept in a sequentially numbered, opaque, sealed envelopes. The first investigator made randomisation of the patients randomly selecting envelope and opening it before operation. Neither second investigator (outcome assessor) nor the patient knew about method of wound closure - with subcutaneous suture or without (author replies)"

Incomplete outcome data (attrition bias)
All outcomes
Low riskComment: there were post-randomisation drop-outs. Imputation by different scenarios did not change the conclusions

Selective reporting (reporting bias)High riskComment: the trial protocol was not available and the trial did not report all the primary outcomes of this review

Tiryakioglu 2010

MethodsRandomised clinical trial


ParticipantsCountry: Turkey.
Number randomised: 82
Post-randomisation drop-outs: 3 (3.7%)
Revised sample size: 79
Average age: 63 years
Male:female ratio: 59 (74.7%): 20 (25.3%)
Inclusion criteria: people having elective saphenous vein graft excision for coronary artery bypass graft surgery


InterventionsParticipants randomly assigned to 2 groups
Group 1 (n = 41): subcutaneous closure
Group 2 (n = 38): no subcutaneous closure

Details of surgery including location and contamination: saphenous vein graft excision (clean)
Details of suture material: Vicryl 2-0
Continuous or interrupted closure of subcutaneous tissue: continuous

Follow-up: 2 months after surgery


OutcomesWound infection


NotesWe attempted to contact the trial authors in February 2013
Reasons for post-randomisation drop-outs: died

Source of funding: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskComment: this information was not available

Allocation concealment (selection bias)Unclear riskComment: this information was not available

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskComment: this information was not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskComment: this information was not available

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskComment: there were post-randomisation drop-outs that might have made a clinically important difference to the treatment effect

Selective reporting (reporting bias)High riskComment: the trial protocol was not available and the trial did not report all the primary outcomes of this review

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Deliaert 2009Not a comparison of subcutaneous versus no subcutaneous sutures

el Gamel 1994aParticipants had bilateral operations (vein excision from the legs) . Each participant had one wound randomised to subcutaneous closure and another wound randomised to no subcutaneous closure. The analysis did not take intra-participant correlation into account nor did the trial provide details to allow us to take the intra-participant correlation into account during meta-analysis.

Milewski 1980Quasi-randomised study (allocation by age of the participant)

Nouraei 2010No information regarding whether the subcutaneous layer was included in the single-layer closure method

Singer 2005No information regarding whether the subcutaneous layer was included in the single-layer closure method

Stenvik 2006No information regarding whether the groups differed in the method of skin closure

Teebken 2000No information regarding whether the groups differed in the method of skin closure

 
Characteristics of ongoing studies [ordered by study ID]
ChiCTR-TRC-11001152

Trial name or titleChiCTR-TRC-11001152

MethodsRandomised controlled trial

ParticipantsPeople undergoing abdominal surgery

InterventionsSubcutaneous suture versus no subcutaneous suture

Outcomeswound healing

Starting date1st October 2010

Contact informationXiao L: wuwei_07@hotmail.com

NotesCurrently recruiting according to Chinese Clinical Trial Registry and WHO Trial Registry details

 
Comparison 1. Subcutaneous closure versus no subcutaneous closure

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Superficial surgical site infection6815Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.53, 1.33]

 2 Superficial wound dehiscence2215Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.22, 1.41]

 3 Deep wound dehiscence160Risk Ratio (M-H, Fixed, 95% CI)0.25 [0.03, 2.11]

 4 Hospital stay3434Mean Difference (IV, Fixed, 95% CI)0.10 [-0.45, 0.64]

 5 Superficial surgical site infection (sensitivity analysis - missing data imputation)6Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    5.1 Best-best analysis
6824Risk Ratio (M-H, Fixed, 95% CI)0.83 [0.52, 1.32]

    5.2 Best-worst analysis
6824Risk Ratio (M-H, Fixed, 95% CI)0.74 [0.47, 1.16]

    5.3 Worst-best analysis
6824Risk Ratio (M-H, Fixed, 95% CI)0.97 [0.63, 1.52]

    5.4 Worst-worst analysis
6824Risk Ratio (M-H, Fixed, 95% CI)0.87 [0.57, 1.33]

 6 Hospital stay (sensitivity analysis)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 7 Superficial surgical site infection (sensitivity analysis - > 30 days)3434Risk Ratio (M-H, Fixed, 95% CI)0.54 [0.25, 1.19]

 8 Superficial wound dehiscence (sensitivity analysis - > 30 days)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Summary of findings for the main comparison. Subcutaneous closure compared to no subcutaneous closure for non-caesarean surgery

Subcutaneous closure compared to no subcutaneous closure for non-caesarean surgery

Patient or population: participants having non-caesarean surgery
Settings: secondary
Intervention: subcutaneous closure of incision
Comparison: no subcutaneous closure of incision

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)

Assumed riskCorresponding risk

No subcutaneous closureSubcutaneous closure

Superficial surgical site infection83 per 100070 per 1000
(44 to 110)
RR 0.84
(0.53 to 1.33)
815
(6 studies)
⊕⊝⊝⊝
very low1,2

Superficial wound dehiscence103 per 100058 per 1000
(23 to 145)
RR 0.56
(0.22 to 1.41)
215
(2 studies)
⊕⊝⊝⊝
very low1,2

Deep wound dehiscence133 per 100033 per 1000
(4 to 281)
RR 0.25
(0.03 to 2.11)
60
(1 study)
⊕⊝⊝⊝
very low1,2

Hospital stayThe mean hospital stay in the control groups was
6 days
The mean hospital stay in the intervention groups was
0.1 higher
(0.45 lower to 0.64 higher)
434
(3 studies)
⊕⊝⊝⊝
very low1,3

*The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: we are very uncertain about the estimate

 1 The trial(s) was (were) of high risk of bias
2 The confidence intervals overlapped 1 and either 0.75 or 1.25 or both. The number of events in the intervention and control group was fewer than 300
3 There was severe heterogeneity as noted by the I2 statistic and the lack of overlap of confidence intervals