Skin WoundNCT06575088
Pneumatic Tourniquet Application in Upper Extremity Surgeries
A study testing Standard tourniquet pressure (250 mmHg), Limb occlusion pressure and Cotton Pad in people with Skin Wound and Complication of Surgical Procedure, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study investigated the effect of cuff pressure and the selection of protective padding material(PPM) on the prevention of skin complications associated with pneumatic tourniquet(PT) application in upper extremity surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Wound, Complication of Surgical Procedure
- What is being tested?
- Standard tourniquet pressure (250 mmHg), Limb occlusion pressure and Cotton Pad
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2022to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who 18 years and older
- Patients who undergoing upper extremity surgery
- Patients who underwent surgery under general and regional anesthesia
- Patients who having no communication problems
- Patients who agreeing to participate in the study
Who cannot join
- Patients who with communication barriers
- Patients who refused to participate in the study
- Patients who aged below 18 years
- Patients who underwent surgery for the second time
- Patients who underwent bilateral extremity surgery
- Patients without pneumatic tourniquet application
Show all 14Show fewer
- Patients who received hypertension treatment
- Patients who diabetes mellitus treatment
- Patients who had skin lesions under the cuff during preoperative observation
- Patients who had active infection
- Patients who had skin complications
- Patients who have an above-elbow splint applied
- Patients who underwent surgical operation associated with malignancy
- Patients with the surgical area located proximal to the elbow
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Republic of Turkey Ministry of Health Bursa City Hospital
Bursa
About this study
Official title: Effect of Cuff Pressure Level and Protective Padding Material Selection on the Prevention of Skin Complications in Pneumatic Tourniquet Applications in Upper Extremity Surgery: Clinical Research
Purpose: This study investigated the effect of cuff pressure and the selection of protective padding material(PPM) on the prevention of skin complications associated with pneumatic tourniquet(PT) application in upper extremity surgery.
Methods: This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX. Standard tourniquet pressure (STP) or limb occlusion pressure (LOP) was applied as PT cuff pressure. Cotton pads or elastic stockinette was used for PPM under the cuff. Patients were categorized into four groups; (i) STP with a cotton pad; (ii) STP with an elastic stockinette; (iii) LOP with a cotton pad; and (iv) LOP with an elastic stockinette. Total of 200 patients were included in the study, with 50 patients in each group. Skin complications were evaluated postoperatively at 0, 30, and 180 min.
Read the detailed description
Pneumatic tourniquet (PT) is frequently used in extremity surgeries because of its advantages, including better surgical field visibility and shorter operation duration. Notwithstanding its advantages, PT can cause a number complications in the postoperative period, including pain, edema, skin complications, muscle injuries, thromboembolism, and neurological damage. Although the risks associated with the use of PT have decreased because of the introduction of adjustable pressure mechanisms and safety alarm systems, complications can still occur. Surgical team members should be knowledgeable about PT to ensure quality and safe patient care. It is of great importance to evaluate the size and shape of the extremity and skin condition prior to PT application, apply the appropriate size cuff, and evaluate the skin under the cuff and peripheral pulses distal to the cuff upon application.
There are different recommendations regarding safety practices for the application of PT in extremity surgeries. Previous studies in the relevant literature reported controversial results regarding the appropriate tourniquet cuff pressure for extremity surgery, and there are different applications for determining the cuff pressure. Previous studies mostly used standard tourniquet pressure (STP). STP is defined as 250 mmHg pressure for the upper extremity and 300 mmHg pressure for the lower extremity. Nevertheless, minimum inflation pressures have been recommended instead of STP to prevent complications likely associated with high pressures. Another method is the use of limb occlusion pressure (LOP). LOP is defined as the minimum pressure required to stop arterial blood flow into the extremity distal to the cuff. LOP can be determined manually or automatically by slowly inflating the cuff and stopping the pulse using certain equipment, including a Doppler flowmeter or pulse oximeter. It was suggested that PT cuff pressure could be minimized by LOP application and that the risk of tourniquet-related complications could be reduced. Most previous studies on PT have focused on the lower extremities. Nevertheless, tourniquet use also been the method of choice in upper extremity surgery to provide a surgical field without blood.
In PT applications, protective padding material (PPM) is placed between the skin and the cuff to prevent skin injuries. The Association of Perioperative Registered Nurses recommends the application of soft, low-lint padding materials, including limb protection sleeves or two layers of stockinette (plaster stocking). The padding material should not compress the skin or cause wrinkles. Fewer skin complications were observed in patients with cotton pads or elastic stockinette than in patients without PPM. There is no material with proven superiority in the use of PPM.
This study investigated the effects of cuff pressure level and the choice of PPM on the prevention of skin complications after PT in upper extremity surgery. It was hypothesized that there was a relationship between the level of cuff pressure and the PPM during use and skin complications during PT applications in upper extremity surgery.
- Conditions
- Skin Wound, Complication of Surgical Procedure
- Being tested
- Standard tourniquet pressure (250 mmHg), Limb occlusion pressure, Cotton Pad, Elastic stockinette
- Keywords
- Skin Complications, Protective Material, Pneumatic Tourniquet, Tourniquet Pressure, Upper Extremity Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard tourniquet pressure (250 mmHg)Other
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Limb occlusion pressureOther
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Cotton PadOther
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
Elastic stockinetteOther
The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.
| Study group | Role | What they receive |
|---|---|---|
| Standard tourniquet pressure with cotton pad | Active comparator | Cotton pad was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure. Receives: Other: Standard tourniquet pressure (250 mmHg); Other: Cotton Pad |
| Standard tourniquet pressure with elastic stockinette | Active comparator | Elastic stockinette was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure. Receives: Other: Standard tourniquet pressure (250 mmHg); Other: Elastic stockinette |
| Limb occlusion pressure with cotton pad | Active comparator | Cotton pad was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure. Receives: Other: Limb occlusion pressure; Other: Cotton Pad |
| Limb occlusion pressure with elastic stockinette | Active comparator | Elastic stockinette was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure. Receives: Other: Limb occlusion pressure; Other: Elastic stockinette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Redness
Redness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance.
Measured: through study completion, an average of 1 year
Tourniquet scar
A tourniquet scar is a scar on the skin in the form of wrinkles and folds aligned with the structure of the sleeve.
Measured: through study completion, an average of 1 year
Petechiae
Petechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve.
Measured: through study completion, an average of 1 year
Bulla
A bulla is considered a fluid-filled blister on the skin.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start14 Oct 2022
- Primary completion30 Jul 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Skin WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were categorized into four groups based on the method of choice for determining the level of tourniquet cuff pressure and the PPM applied under the cuff. (i) . Standard tourniquet pressure (STP) with cotton pad; (ii) STP with elastic stockinette; (iii) limb occlusion pressure (LOP) with cotton pad; and finally, LOP with elastic stockinette. Power analysis was performed using the PASS software for sample size calculation. 50 patients were included in each group, considering that some patients might discontinue the trial. Block randomization method was used to randomize patients into study groups. The independent variables of the study were skin complications associated with tourniquet application on the skin under the sleeve. Complications were identified by the study team and confirmed by clinic nurses, and there was no disagreement regarding the occurrence of complications.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sevgi Vermişli, Bursa City Hospital
- Investigators
- Sevgi Vermisli Ciftci, Ph.D., Study chair, Republic of Turkey Ministry of Health Bursa City Hospital/Operating RoomZeki Gunsoy, M.D., Principal investigator, Republic of Turkey Ministry of Health Bursa City Hospital/Hand Surgery ClinicFatma Demir Korkmaz, Professor, Principal investigator, Ege University/ Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575088
- Sponsor's protocol ID
- 2022-12/5
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydin A, Kanan N. Effect of Protective Padding in Pneumatic Tourniquet Applications on the Prevention of Skin Complications. Orthop Nurs. 2022 Jul-Aug 01;41(4):260-268. doi: 10.1097/NOR.0000000000000857.
PubMed 35869912Jensen J, Hicks RW, Labovitz J. Understanding and Optimizing Tourniquet Use During Extremity Surgery. AORN J. 2019 Feb;109(2):171-182. doi: 10.1002/aorn.12579.
PubMed 30694553Bosman HA, Robinson AH. Pneumatic tourniquet use in foot and ankle surgery--is padding necessary? Foot (Edinb). 2014 Jun;24(2):72-4. doi: 10.1016/j.foot.2014.03.007. Epub 2014 Mar 25.
PubMed 24745802Din R, Geddes T. Skin protection beneath the tourniquet. A prospective randomized trial. ANZ J Surg. 2004 Sep;74(9):721-2. doi: 10.1111/j.1445-1433.2004.03143.x.
PubMed 15379794McMillan TE, Johnstone AJ. Tourniquet uses and precautions. Surg (United Kingdom). 2017;35(4):201-203. doi:10.1016/j.mpsur.2017.01.011
Olivecrona C, Tidermark J, Hamberg P, Ponzer S, Cederfjall C. Skin protection underneath the pneumatic tourniquet during total knee arthroplasty: a randomized controlled trial of 92 patients. Acta Orthop. 2006 Jun;77(3):519-23. doi: 10.1080/17453670610012539.
PubMed 16819695Spruce L. Back to Basics: Pneumatic Tourniquet Use. AORN J. 2017 Sep;106(3):219-226. doi: 10.1016/j.aorn.2017.07.003.
PubMed 28865632Sun C, Yang X, Zhang X, Ma Q, Yu P, Cai X, Zhou Y. Personalized tourniquet pressure may be a better choice than uniform tourniquet pressure during total knee arthroplasty: A PRISMA-compliant systematic review and meta-analysis of randomized-controlled trials. Medicine (Baltimore). 2022 Feb 25;101(8):e28981. doi: 10.1097/MD.0000000000028981.
PubMed 35212310Martinez-Rico S, Lizaur-Utrilla A, Sebastia-Forcada E, Vizcaya-Moreno MF, de Juan-Herrero J. The Impact of a Phone Assistance Nursing Program on Adherence to Home Exercises and Final Outcomes in Patients Who Underwent Shoulder Instability Surgery: A Randomized Controlled Study. Orthop Nurs. 2018 Nov/Dec;37(6):372-378. doi: 10.1097/NOR.0000000000000501.
PubMed 30451774Bowen BA. Orthopedic Surgery. In: ROTHROCK JC, McEwen DR, eds. Alexander's Care of the Patient in Surgery. 16th ed. Optum/UnitedHealthCare San Antonio, Texas: Elsevier; 2018:2050-2300.
Hicks RW, Denholm B. Implementing AORN recommended practices for care of patients undergoing pneumatic tourniquet-assisted procedures. AORN J. 2013 Oct;98(4):383-93; quiz 394-6. doi: 10.1016/j.aorn.2013.08.004.
PubMed 24075334Yalcinkaya M, Sokucu S, Erdogan S, Kabukcuoglu YS. Tourniquet use in orthopedic surgery: a descriptive survey study among Turkish orthopedic surgeons and residents in Istanbul. Acta Orthop Traumatol Turc. 2014;48(5):483-90. doi: 10.3944/AOTT.2014.14.0068.
PubMed 25429571Olaiya OR, Alagabi AM, Mbuagbaw L, McRae MH. Carpal Tunnel Release without a Tourniquet: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2020 Mar;145(3):737-744. doi: 10.1097/PRS.0000000000006549.
PubMed 32097317Pinto A, Moniz J, Dinis A, Santos N, Carmona C. Pneumatic tourniquet in orthopedic surgery, an institutional good practices review. Reg Anesth Pain Med. 2022;47(Suppl 1):A1-A315. doi:10.1136/rapm-2022-ESRA.252 Background
McEwen JA, Kelly DL, Jardanowski T, Inkpen K. Tourniquet safety in lower leg applications. Orthop Nurs. 2002 Sep-Oct;21(5):55-62. doi: 10.1097/00006416-200209000-00009.
PubMed 12432700
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cuff Pressure Level and Protective Padding Material Selection on the Prevention of Skin Complications in Pneumatic Tourniquet Applications in Upper Extremity Surgery: Clinical Research
- ClinicalTrials.gov ID
- NCT06575088
- Acronym / sponsor ID
- 2022-12/5
- Conditions
- Skin Wound, Complication of Surgical Procedure
- Keywords
- Skin Complications, Protective Material, Pneumatic Tourniquet, Tourniquet Pressure, Upper Extremity Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This study investigated the effect of cuff pressure and the selection of protective padding material(PPM) on the prevention of skin complications associated with pneumatic tourniquet(PT) application in upper extremity surgery.
Methods: This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX. Standard tourniquet pressure (STP) or limb occlusion pressure (LOP) was applied as PT cuff pressure. Cotton pads or elastic stockinette was used for PPM under the cuff. Patients were categorized into four groups; (i) STP with a cotton pad; (ii) STP with an elastic stockinette; (iii) LOP with a cotton pad; and (iv) LOP with an elastic stockinette. Total of 200 patients were included in the study, with 50 patients in each group. Skin complications were evaluated postoperatively at 0, 30, and 180 min.
Detailed description
Pneumatic tourniquet (PT) is frequently used in extremity surgeries because of its advantages, including better surgical field visibility and shorter operation duration. Notwithstanding its advantages, PT can cause a number complications in the postoperative period, including pain, edema, skin complications, muscle injuries, thromboembolism, and neurological damage. Although the risks associated with the use of PT have decreased because of the introduction of adjustable pressure mechanisms and safety alarm systems, complications can still occur. Surgical team members should be knowledgeable about PT to ensure quality and safe patient care. It is of great importance to evaluate the size and shape of the extremity and skin condition prior to PT application, apply the appropriate size cuff, and evaluate the skin under the cuff and peripheral pulses distal to the cuff upon application.
There are different recommendations regarding safety practices for the application of PT in extremity surgeries. Previous studies in the relevant literature reported controversial results regarding the appropriate tourniquet cuff pressure for extremity surgery, and there are different applications for determining the cuff pressure. Previous studies mostly used standard tourniquet pressure (STP). STP is defined as 250 mmHg pressure for the upper extremity and 300 mmHg pressure for the lower extremity. Nevertheless, minimum inflation pressures have been recommended instead of STP to prevent complications likely associated with high pressures. Another method is the use of limb occlusion pressure (LOP). LOP is defined as the minimum pressure required to stop arterial blood flow into the extremity distal to the cuff. LOP can be determined manually or automatically by slowly inflating the cuff and stopping the pulse using certain equipment, including a Doppler flowmeter or pulse oximeter. It was suggested that PT cuff pressure could be minimized by LOP application and that the risk of tourniquet-related complications could be reduced. Most previous studies on PT have focused on the lower extremities. Nevertheless, tourniquet use also been the method of choice in upper extremity surgery to provide a surgical field without blood.
In PT applications, protective padding material (PPM) is placed between the skin and the cuff to prevent skin injuries. The Association of Perioperative Registered Nurses recommends the application of soft, low-lint padding materials, including limb protection sleeves or two layers of stockinette (plaster stocking). The padding material should not compress the skin or cause wrinkles. Fewer skin complications were observed in patients with cotton pads or elastic stockinette than in patients without PPM. There is no material with proven superiority in the use of PPM.
This study investigated the effects of cuff pressure level and the choice of PPM on the prevention of skin complications after PT in upper extremity surgery. It was hypothesized that there was a relationship between the level of cuff pressure and the PPM during use and skin complications during PT applications in upper extremity surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Patients were categorized into four groups based on the method of choice for determining the level of tourniquet cuff pressure and the PPM applied under the cuff. (i) . Standard tourniquet pressure (STP) with cotton pad; (ii) STP with elastic stockinette; (iii) limb occlusion pressure (LOP) with cotton pad; and finally, LOP with elastic stockinette. Power analysis was performed using the PASS software for sample size calculation. 50 patients were included in each group, considering that some patients might discontinue the trial. Block randomization method was used to randomize patients into study groups. The independent variables of the study were skin complications associated with tourniquet application on the skin under the sleeve. Complications were identified by the study team and confirmed by clinic nurses, and there was no disagreement regarding the occurrence of complications.
| Arm | Type | Receives |
|---|---|---|
| Standard tourniquet pressure with cotton pad | Active comparator | Other: Standard tourniquet pressure (250 mmHg), Other: Cotton PadCotton pad was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure. |
| Standard tourniquet pressure with elastic stockinette | Active comparator | Other: Standard tourniquet pressure (250 mmHg), Other: Elastic stockinetteElastic stockinette was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure. |
| Limb occlusion pressure with cotton pad | Active comparator | Other: Limb occlusion pressure, Other: Cotton PadCotton pad was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure. |
| Limb occlusion pressure with elastic stockinette | Active comparator | Other: Limb occlusion pressure, Other: Elastic stockinetteElastic stockinette was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who 18 years and older
- Patients who undergoing upper extremity surgery
- Patients who underwent surgery under general and regional anesthesia
- Patients who having no communication problems
- Patients who agreeing to participate in the study
Key exclusion criteria (14 listed)
- Patients who with communication barriers
- Patients who refused to participate in the study
- Patients who aged below 18 years
- Patients who underwent surgery for the second time
- Patients who underwent bilateral extremity surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard tourniquet pressure (250 mmHg)The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared. | Other | Standard tourniquet pressure with cotton pad, Standard tourniquet pressure with elastic stockinette |
| Limb occlusion pressureThe effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared. | Other | Limb occlusion pressure with cotton pad, Limb occlusion pressure with elastic stockinette |
| Cotton PadThe effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared. | Other | Limb occlusion pressure with cotton pad, Standard tourniquet pressure with cotton pad |
| Elastic stockinetteThe effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared. | Other | Limb occlusion pressure with elastic stockinette, Standard tourniquet pressure with elastic stockinette |
Primary outcome
Redness
Time frame: through study completion, an average of 1 year
Redness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance.
Tourniquet scar
Time frame: through study completion, an average of 1 year
A tourniquet scar is a scar on the skin in the form of wrinkles and folds aligned with the structure of the sleeve.
Petechiae
Time frame: through study completion, an average of 1 year
Petechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve.
Bulla
Time frame: through study completion, an average of 1 year
A bulla is considered a fluid-filled blister on the skin.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 35869912Aydin A, Kanan N. Effect of Protective Padding in Pneumatic Tourniquet Applications on the Prevention of Skin Complications. Orthop Nurs. 2022 Jul-Aug 01;41(4):260-268. doi: 10.1097/NOR.0000000000000857.
- Background: PubMed 30694553Jensen J, Hicks RW, Labovitz J. Understanding and Optimizing Tourniquet Use During Extremity Surgery. AORN J. 2019 Feb;109(2):171-182. doi: 10.1002/aorn.12579.
- Background: PubMed 24745802Bosman HA, Robinson AH. Pneumatic tourniquet use in foot and ankle surgery--is padding necessary? Foot (Edinb). 2014 Jun;24(2):72-4. doi: 10.1016/j.foot.2014.03.007. Epub 2014 Mar 25.
- Background: PubMed 15379794Din R, Geddes T. Skin protection beneath the tourniquet. A prospective randomized trial. ANZ J Surg. 2004 Sep;74(9):721-2. doi: 10.1111/j.1445-1433.2004.03143.x.
- BackgroundMcMillan TE, Johnstone AJ. Tourniquet uses and precautions. Surg (United Kingdom). 2017;35(4):201-203. doi:10.1016/j.mpsur.2017.01.011
- Background: PubMed 16819695Olivecrona C, Tidermark J, Hamberg P, Ponzer S, Cederfjall C. Skin protection underneath the pneumatic tourniquet during total knee arthroplasty: a randomized controlled trial of 92 patients. Acta Orthop. 2006 Jun;77(3):519-23. doi: 10.1080/17453670610012539.
- Background: PubMed 28865632Spruce L. Back to Basics: Pneumatic Tourniquet Use. AORN J. 2017 Sep;106(3):219-226. doi: 10.1016/j.aorn.2017.07.003.
- Background: PubMed 35212310Sun C, Yang X, Zhang X, Ma Q, Yu P, Cai X, Zhou Y. Personalized tourniquet pressure may be a better choice than uniform tourniquet pressure during total knee arthroplasty: A PRISMA-compliant systematic review and meta-analysis of randomized-controlled trials. Medicine (Baltimore). 2022 Feb 25;101(8):e28981. doi: 10.1097/MD.0000000000028981.
- Background: PubMed 30451774Martinez-Rico S, Lizaur-Utrilla A, Sebastia-Forcada E, Vizcaya-Moreno MF, de Juan-Herrero J. The Impact of a Phone Assistance Nursing Program on Adherence to Home Exercises and Final Outcomes in Patients Who Underwent Shoulder Instability Surgery: A Randomized Controlled Study. Orthop Nurs. 2018 Nov/Dec;37(6):372-378. doi: 10.1097/NOR.0000000000000501.
- BackgroundBowen BA. Orthopedic Surgery. In: ROTHROCK JC, McEwen DR, eds. Alexander's Care of the Patient in Surgery. 16th ed. Optum/UnitedHealthCare San Antonio, Texas: Elsevier; 2018:2050-2300.
- Background: PubMed 24075334Hicks RW, Denholm B. Implementing AORN recommended practices for care of patients undergoing pneumatic tourniquet-assisted procedures. AORN J. 2013 Oct;98(4):383-93; quiz 394-6. doi: 10.1016/j.aorn.2013.08.004.
- Background: PubMed 25429571Yalcinkaya M, Sokucu S, Erdogan S, Kabukcuoglu YS. Tourniquet use in orthopedic surgery: a descriptive survey study among Turkish orthopedic surgeons and residents in Istanbul. Acta Orthop Traumatol Turc. 2014;48(5):483-90. doi: 10.3944/AOTT.2014.14.0068.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevgi Vermisli Ciftci, Ph.D. study chair
Republic of Turkey Ministry of Health Bursa City Hospital/Operating Room
Zeki Gunsoy, M.D. principal investigator
Republic of Turkey Ministry of Health Bursa City Hospital/Hand Surgery Clinic
Fatma Demir Korkmaz, Professor principal investigator
Ege University/ Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard tourniquet pressure (250 mmHg), Limb occlusion pressure and Cotton Pad in people with Skin Wound and Complication of Surgical Procedure, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Redness (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575088, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.